The First BioBeers at Brewers Alley

I think everyone had a great time last night at brewers Alley.  I am a bit disappointed that the AV situation was lousy, yet again (although the Bull Horn at Flying Dog is quite effective).  We estimate that attendance topped 100 again and there were alot of fresh, new faces in attendance.

My thanks (and apologies) again to the Sponsors Tyler-Donegan, Horiba, Microfluidics and UMBC.

I’ve heard nothing but glowing reviews from those in attendance, so thought I’d put a short slideshow together so you can prove you were actually there in the event you don’t remember.

FedBizOps Opportunities at Ft Detrick: Where’s the Beef?

I was stunned last week when I talking with an acquaintance of mine who is a Contract Specialist at SAIC-Frederick.  I was stunned because I didn’t know he was in the Science business (technically, he’s more like a purchasing agent) and because he was complaining that he gets so little responses from local suppliers RFI and RFQ that many times these “Purchase Orders” just expire.  I told him that I’d post some of these current opportunities, because I know many FredCoBio companies would love to have the chance to get a contract through SAIC.

Here’s the Beef.  A full  palette of delicious, juicy contracts just waiting to be bid upon. Viewable on FedBizOps:

S09-112 – Cell Line Development Services If no one jumps on this one, I’ll scream!!

Response Date: May 1, 2009 by 4:00PM Eastern

Archive date: May 30, 2009

Classification Code: A – Research and Development NAICS: 541711

Set Aside: N/A

Contracting office address: SAIC-Frederick, Inc.
National Cancer Institute at Frederick
92 Thomas Johnson Drive, Suite 250
Frederick, MD 21702-1201

Summary:

A contract manufacturing organization or supplier with the ability to economically develop a mammalian cell line expressing a therapeutic protein including but not limited to chimeric or humanized monoclonal antibodies, antibody fragment fusion proteins, or recombinant cytokines in an established cell line, such as CHO suspension cells, HEK 293 cells, or NS0 cells with stable expression level at 10-50pg/cell/day using a batch, fed-batch, or perfusion process.

Service Requirement:

Potential respondents are to provide detailed description of technical approaches and experience, as well as estimated costs in performing the activities detailed below:

Product Gene

1) SAIC-F would provide a gene sequence of an antibody or antibody fragment fusion with a protein, or a recombinant protein with construct size <10-12KB.
2) Respondents will provide description of sequence analysis and codons optimization for expression in mammalian cells using either direct synthesis or codon optimization techniques.

Product Expression Regulation

1) Respondents will provide a description of promoter; e.g., CMV or equivalent strong mammalian cell promoters.
2) Respondents will use a leading peptide to express the protein as secreted form.
3) Respondents will use a terminator or terminators to enhance target gene transcription.
4) Respondents will provide details on removal of introns to improve transcriptional yield where acceptable.

Cloning Requirement

1) Respondents will describe a selection system (GS or dhfr-) to be used in the expression system. Alternatives to the use of a selection system may also be described by the respondent.
2) Respondents will describe an additional selection to facilitate enriching high producer may be described; however SAIC-F requires to use a system previously approved by FDA for clinical trials.
3) Full length plasmid sequencing is required. A high transgene copy number in the cell line is preferred but not required.

Cell Line Requirement

1) Respondents will describe the proposed host cell line, such as CHO suspension cells, HEK 293 cells, or NS0 cells.
2) Respondents will describe how the host cell lines are qualified for use.
3) Respondents will provide how sequencing of the promoter and transgene coding region in the selected high producer is performed. Messenger RNA sequence and information regarding the location of the transgene(s) in the host cell is preferred but not required.

Procedure Requirement

1) Respondents will describe procedures for how the constructed plasmid DNA is transfected into a selected cell line; to include:
a) A stable transfection pool.
b) Single cell cloning methods.
2) If a selection system is used in expression, a reasonable transfected clone number (depend upon the system) is required; please describe. If there is no selection system is used to enrich high producer, more than 1000 single clones are required to select for expression screening.
3) Responder will describe procedures to evaluate cell growth and productivity based on respondent’s selection on medium and culture condition.
Cell Growth and Productivity Requirement

1) Respondents will describe how the following that would be delivered:
a) A serum-free or protein-free medium adaptation.
b) Cell growth to reach 5-10 a 106 cells/mL.
c) Cell doubling time in the range of 20-30hour.
d) Viability of culture greater than 90%.
e) More than 5 days for batch process or more than 9 days for fed-batch process.
f) Productivity of greater than 10pg/cell/day is required.
2) Respondents will describe methods used to characterize the expression candidate protein or previous experience working with clients to achieve characterization.

Key Requirements to be considered for the areas above include:

1) A traceable history of the host cell used in the study.
2) A clear history of the plasmid vector used in the study.
3) A cell culture medium that is GMP compliant.
4) Generation of a cell line expressing a product is well documented.
5) All the sequence information of the plasmid and cell line to be made available in standard electronic formats.

S09-135  Endotoxin Production

Purpose of RFI:

SAIC-F is to seeking to identify a qualified contract research organization that is able to economically produce a new batch of clinical grade bulk endotoxin that is compliant with current Good Manufacturing Practices to replace the > 30 year old bulk endotoxin currently in storage. PLEASE NOTE: An appropriate strain of E. coli would be required to be acquired by any potential Subcontractor should a Request for Proposal (RFP) and subsequent Subcontracting Agreement be offered to a selected offeror.

Project Goal:

The goal included in this statement of work is to produce a new batch of clinical grade bulk endotoxin that is compliant with current Good Manufacturing Practices to replace the > 30 year old bulk endotoxin currently in storage. This project will be broken down into a Development Section, including MCB production, and purification process development. An engineering run of bulk endotoxin along with a pilot lyophilization study. The final stage includes cGMP Production; including GMP bulk endotoxin manufacture and GMP vialing and lyophilization plus a manufacturing report.

Anticipated Milestones and Deliverables:

Milestone 1 – Activity A: Production and characterization of a 200 vial Master Cell Bank.

The previous cGMP endotoxin was produced from the Escherichia coli (Braude strain) group O 113:H10:K negative strain that was isolated and characterized at the Bacteriology Division, Bureau of Laboratories, Center for Disease Control, Atlanta, Georgia (Ewing WH, Hucks MC, and Taylor MW (1952) J Bacteriology 63: 319-325). The BDP will contact Dr. Epstein to determine if this bacterial strain is available from the NIH Clinical Center, the FDA, or the CDC.

The potential Subcontractor will obtain the appropriate strain of E. coli and then manufacture and characterize the 200 vial MCB according to current standards. The potential Subcontractor will provide a list of tests to be performed. SAIC-F may provide the potential Subcontractor a source of the required strain if necessary.

Milestone 1 – Activity B: Purification Development.

R&D grade E. coli cultures will be produced using the previously recommended chemically defined media and conditions. These cultures will be produced in the potential Subcontractor’s laboratories using standard R&D procedures and it is expected that this process will require minimal development work.

The resulting cell pellets will be used for purification development following the previous purification process used > 30 years ago. The potential Subcontractor will provide a proposal for process modification (if any) to meet the required scale, cGMP compliance, and product quality. Such studies may include:

1. A 10 liter culture will be produced and subjected to phenol extraction to produce a single unpurified bulk that can be used for purification development studies.
2. Tests to replace a dialysis step with transmembrane flow filtration (TFF).
3. Determine whether the deoxyribonuclease digestion can be replaced with Benzonase digestion.
4. Testing chromatography as a replacement for the sodium acetate/ethanol concentration step.
5. Determine whether the final dialysis step can be replaced with TFF.

Milestone 1 – Activity C: R&D Assay Development.

The potential Subcontractor will identify any method development necessary to perform the required release testing for the bulk and final vialed product shown in Tables 1 and 2.

SPECIAL NOTE: SAIC-F, with the NCI, will contact the US FDA for review of the proposed methods of analysis and specifications prior to initiation of the cGMP phase of the program. The results of that future discussion will be shared with the potential Subcontractor.

Milestone 2: Engineering Run/Pilot Lyophilization

The potential Subcontractor’s laboratories will be used to perform a cGMP pilot run. A full scale production and purification will be performed to test the process and produce bulk drug substance. This drug substance will be used as an internal reference standard for the following studies:

1. QC assay development.
2. QC testing for comparability to previous endotoxin CC-RE-Lot3.
3. Drug Substance stability studies.

The potential Subcontractor may perform any or all of these studies. The potential Subcontractor will also perform pilot formulation and lyophilization studies based on requirements to produce final vialed product listed in Table 3.

Milestones 3 &4: Production of cGMP Endotoxin

The potential Subcontractor will perform a full scale production and purification to produce cGMP grade endotoxin including the following activities:

1. Controlled fermentation will be conducted in a batch mode.
2. Purification will be performed to produce bulk drug substance.
3. QC/QA release of the drug substance.
4. Formulation, vialing, and labeling of endotoxin drug product (FVP).
5. QC/QA release of the FVP.
6. Stability program for FVP and, if required, bulk biological substance
7. Preparation of a Manufacturing Report (Appendix 1) to be included in
submissions to the US FDA with authorization to cross-reference any required
potential Subcontractor submissions to enable full review of the manufacturing
and testing documents by the US FDA for IND studies.

Table 1: Methods of Analysis and Specification for Bulk Biological Substance

Method Product Specification
Kinetic – QCL Potency Assay (EU/mL) (3) NLT 50,000 EU/mL
Gel Clot Potency Assay (EU/mL) (3) NLT 50,000 EU/mL
Sterility(1) Negative per 21CFR610.12
Residual host cell protein For Information Only
Residual host DNA For Information Only
Residual phenol(2) For Information Only
Mass spectrometry; method to be proposed by Contractor For Information Only
Polysaccharide characterization; method to be proposed by Contractor For Information Only
(1) Bacteriostasis & fungistatsis analysis to be performed on representative sample
(2) Additional residuals analysis may be required based on the potential process-related contaminants.
(3) Stability indicating assay

Table 2: Methods of Analysis and Specification for Final Vialed Product

Method Product Specification
Kinetic – QCL Potency Assay (EU/vial) 5,000 – 15,000 EU
Gel Clot Potency Assay (EU/vial) 5,000 – 15,000 EU
Sterility Negative per 21CFR610.12 & cUSP
Residual moisture <=3.0%
Note: All methods are stability indicating assays

Table 3: Required Deliverables for Milestone 3 & Milestone 4

CGMP Production Stage Minimum Quantity Configuration
Final Bulk Biological Substance 1.25 x 108 EU from 62.5 liters Final buffer is 1% lactose, 0.1% PEG-6000 to be bulk filled into sterile glass 10L bottles (8 L per bottle) and stored at 2-8oC
Final Vialed Product, Lyophilized 10,000 vials, net stability and release sampling; 2,000 EU/mL when reconstituted with 5 mL Water-For-Injection (WFI) 10,000 EU per vial in Type II borosilicate glass vials with 20mm stoppers and 20 mm West Aluminum seals. Sterile, single use vials stored at 2-8oC

S09-117 – DNA Plasmid Development Services

Summary:

A contract manufacturing organization or supplier with the ability to develop a process, and perform manufacturing for DNA plasmids for therapeutics and vaccines, using an established cell line, such as E. coli DH 5 alpha with productivity of not less than 800mg/liter of purified plasmid DNA in fermentation broth. It is also required to demonstrate that high quality of plasmid product including but not limited greater than 90% of supercoiled DNA can be purified from the broth.

Service Requirement:

Potential Offerors are to provide detailed description of technical approaches and experience, as well as estimated costs in performing the activities detailed below:

Standard Plasmid Construct – Assume a gene insert would be provided to the Offeror for the purposes of responding to this Request for Information/Sources-Sought Notice:

1) Plasmid contains several basic components including but not limited to promoter(s) to allow gene expression in a mammalian cells and/or tissues; with bacterial replication capability in either high or low copy number, and with no beta-lactmase resistance marker.

2) Plasmid with size of less than 12Kb.

3) Plasmid carries at least one protein coding sequence for expression in mammalian cells and/or tissues.

Production System and Productivity

1) E. coli DH 5 alpha or equivalent FDA accepted E. coli strain that can be employed as host cell for production of a plasmid.

2) The E. coli cells used for production meet FDA requirements for GMP manufacturing. The Offeror is to provide standard listing of procedures to establish and characterize Master Cell Bank.

3) It is required to demonstrate that the productivity is 800mg/liter or higher of fermentation broth at 10 liter or larger fermentation scale. The Offeror is requested to provide experience with specific data.

4) It is required to demonstrate at small scale that the plasmid can be purified from the fermentation broth at reasonable purification yield. The Offeror is requested to provide experience with specific data.

Product Characterization and Quality Requirements

1) A full length plasmid DNA sequence is required; the Offeror is to provide methods used and identify any subcontract relationships, if applicable

2) It is required to demonstrate that the purified plasmid is acceptable in quality including but not limited to higher than 90% of supercoiled plasmid.

cGMP Production

1) The Offeror is to provide facility and operational description for production of purified plasmid DNA under GLP and/or cGMP conditions. Examples of previous experience are requested.

2) It is requested that production be demonstrated for at least 5 g purified plasmid DNA per batch. The Offeror is requested to provide information on experience for large scale DNA plasmid production.

No Plans for the Weekend, but next week is prime

I am looking forward to a nice long hot weekend, with temperature expecting to approach 90 F.  I need to find some time to hunt mushrooms between moving a pile of rock & sand from a friends house and getting the pool in shape for swimming.  Aside from that, I hope to have plenty of quality time in a vegetal state, absorbing vitamin D.

Next week is going to be a big one, with a number of “work related” distractions (must generate more revenue and customers), the AFCEA Frederick Golf outing on Tuesday, BioBeers on Wednesday and the Spring Research Festival at Ft Detrick on Wednesday & Thursday.

Speaking of BioBeers I am happy to announce that our speakers are all ready to roll and our sponsorship is booked!

Tyler-Donegan is taking care of the beer tab and Horiba Labs, Anatom and Microfluidics are taking care of the munchies.

So this makes a first, where only one of the four sponsors are actually FredCoBio companies! Just goes to show that everyone wants to be in FredCoBio! We have over 80 confirmed RSVP’s already and we’re going to have to keep attendance under 120, so if you are coming, please RSVP today!  I am stunned, but not really shocked that only 16 people have signed up for the GoogleGroups page.  Geesh, good thing I am not trying to do a Science 2.0 or Web 2.0 group.  Looks like we’re going to have big groups from Lonza, USAMRIID and DynPort.

Enough bitching.  There’s beer to be had and we have an interesting presentation by my old FITCI chums Integrated Biotherapeutics.  Robert Unfer, Assistant Director Vaccine Development at IBT is going to whip the crowd into a frenzy by talking about “A Method for Decreasing Size Variability of Virus-Like Particle (VLP) Vaccine Preparations”.

Since it will be crowded at Brewers next week, I thought I’d post the abstract of the talk and a couple of figures.  There will be a test and I’ve figured out that talking about really geeky science stuff is a way to keep all the Sales people at bay.  Can’t keep them away, but thinning the herd every once in a while is a good thing.

A Method for Decreasing Size Variability of Virus-Like Particle (VLP) Vaccine Preparations

Background:  Established and emerging pathogens present a continuous challenge to health professionals and governments. There is a need for efficacious, cost-effective, and easily produced vaccines that can provide prophylactic and possible preventative therapy for many viral infections and diseases. Virus-Like Particles (VLP) provide an excellent vehicle to deliver important antigens to the immune system, while avoiding pitfalls and problems that are associated with other live replicating vaccine delivery systems. 

Methods:  VLP’s consisting of the major viral structural proteins can be produced in both mammalian and insect cells, and while they may assume similar morphologies to the native virus, they are often extensively pleomorphic. This may present problems for large-scale production and purification.  Since VLP’s are composed of lipid bilayer structures and have the potential to reform after disruption, Microfluidization using high shear pressures could reduce the size variability of VLP’s and ease purification.  In the present work, VLP supernatant produced using insect cells was analyzed for size variability by dynamic light scattering (Horiba LB-550 DLS) and laser diffraction (Horiba LA-950 Laser Diffraction Analyzer) both prior to and after processing with the M-110Y high shear Microfluidizer. The results were compared to determine which instrument was best for analysis of the VLP size distribution.  VLP’s were processed with either 2000 psi or 5000 psi, and either one or two system passes.  In addition, VLP’s previously purified by standard laboratory methods were analyzed for size variability both prior to and after processing. 

Results:  While direct comparison of DLS and Laser Diffraction was not possible, there is strong indication that the LA-950 will provide more precise and reproducible analysis and measurement of VLP particle sizes.  Pre-processed VLP’s exhibited sizes ranging from 80 nm to 1.6 uM.  Optimal results were observed using 2000 psi and two system passes, and demonstrated a more narrow size range of 90 nm to 0.35 uM.  Processed VLP’s were assayed for antigenicity by ELISA and Western Blot with specific antibodies. Both assays demonstrated no change in antigenicity.  Immunogenicity studies in mice have also been initiated.  

Conclusions:  The reduction in size variability has the potential to ease VLP vaccine purification processes.  And the retention of VLP antigenicity indicates that the vaccine effectiveness may not be affected.  Further studies are needed including further comparison of the two methods of size analysis however; microfluidization may provide an effective method in VLP vaccine production.

Figures:

SAIC-Frederick: Word from the Post

I have been talking with Frank Blanchard, Director of Public Affairs for SAIC-Frederick for a while now.  We’re trying to do a better job (well at least I am, frank’s already doing a fine job) of getting out the word on what kind of research is being done by SAIC contractors on the Post, primarily with the NCI labs.  He’s forwarded a number of interesting articles/Press releases for your reading pleasure.

From 30 March 2009:

Cancer Treatments Using Nanotechnology will Move Closer to Human Clinical Trials under NCI Initiative

FREDERICK, Md., March 30, 2009 – Two new nanotechnology concepts will undergo preclinical characterization as part of the National Cancer Institute (NCI) Advanced Technology Partnerships Initiative to accelerate the development of new treatments for cancer patients.

NCI has entered into separate agreements with Azaya Therapeutics Inc. and Lankenau Institute for Medical Research and its collaborating institute, Massachusetts Institute of Technology, to perform preclinical characterization of the companies’ proprietary nanotechnologies as a prelude to early-phase human clinical trials.

Under the Azaya agreement, the NCI’s Nanotechnology Characterization Laboratory (NCL)—operated by SAIC-Frederick, Inc. as part of the NCI Alliance for Nanotechnology in Cancer—will focus on characterization of Azaya’s lead cancer therapy (ATI-1123) for its adsorption, distribution and toxicity properties using standardized physico-chemical, in-vitro, and in-vivo assays.

The studies will provide a better understanding of the physical and biological properties of ATI-1123 and will support Azaya’s Investigational New Drug (IND) filings with the U.S. Food and Drug Administration.

Azaya’s product is an advanced liposomal formulation of the widely prescribed Taxotere® (docetaxel), a drug for breast, gastric, head and heck, ovarian, prostate, and non-small cell lung cancers.

Under a separate agreement, the NCL will perform preclinical studies on Lankenau’s novel therapeutic nanoparticles for treating solid tumors.

The initial study will focus on adsorption, distribution, and toxicity properties of Lankenau’s polymeric nanoparticle delivery system, which is designed to deliver toxin to tumors without harming normal tissue. Early stage laboratory studies targeted models of prostate, ovarian, pancreatic, and cervical cancers.

Both agreements fall under the ATPI, which seeks to accelerate the development and delivery of new treatments to cancer patients through strategic partnerships with industry, academia, and the nonprofit sector.

From Nature on March 4th: (see also this related story from the LA Times)

Novel Approach Prevents AIDS-Virus Sexual Transmission in Primates

An inexpensive and widely used additive to food and cosmetics has been shown to prevent transmission of a primate version of the AIDS virus.

The research, published online in the March 4 issue of the journal Nature, represents a novel strategy in the search for a safe, affordable, and effective means to prevent the spread of AIDS, especially via sexual transmission to women.

The strategy exploits a recent finding about sexual transmission of AIDS viruses.  Using a monkey model of sexual transmission of AIDS virus, the scientists showed that vaginal exposure to the virus, even in excessive amounts, initially only infects a relatively small number of cells. Without additional target cells, the infection would fail to progress, remain localized, and not cause AIDS.

The immune system, however, responds to the virus by recruiting immune cells (T cells) to the site of infection. This provides the virus with new target cells and the means to spread and establish a systemic infection that can lead to AIDS.

In the current research, investigators at the University of Minnesota, SAIC-Frederick, and collaborating institutions wondered if dampening the initial host response might deprive the virus of new target cells and thereby prevent the virus from establishing itself throughout the body.

In testing this novel idea, they focused on the critical window of opportunity at the earliest stages of infection, when only a limited number of cells are infected, before the virus has spread, a time when the virus is most vulnerable.  To try to block recruitment of new target cells by the virus, they chose a safe, widely used compound-glycerol monolaurate (GML).

GML is a naturally occurring compound used in food and cosmetics to protect consumers from microbes and associated inflammatory reactions, including toxic shock syndrome. GML has antibacterial properties, but also inhibits signaling molecules that stimulate the immune system, which can cause inflammation.

The scientists used a primate version of HIV known as simian immunodeficiency virus (SIV). Applied vaginally, GML prevented infection even after repeated exposure to high doses of the monkey virus.

“This result represents a highly encouraging new lead in the search for an effective microbicide to prevent HIV-1 transmission that meets the criteria of safety, affordability, and efficacy,” the group reported.

GML is a novel approach in that it lacks the direct antiviral activity of most compounds that have been used so far to try to block sexual transmission of HIV. But the initial success of this approach might be enhanced further by using GML or a similar compound in combination with antiviral agents that directly attack the virus.

While the results are promising, additional research involving larger groups of animals over longer periods of time will be necessary before human clinical trials can be considered.

The research is in line with an intensive new focus in the battle against AIDS. With limited progress toward a vaccine, and the rampant spread of the disease, scientists are looking with renewed interest at prevention strategies that focus on sexual transmission, which is leading the spread of the disease worldwide.

Globally, there were 2.7 million new cases of HIV and 2 million HIV-related deaths in 2007 (www.unaids.org). In sub-Saharan Africa, which accounts for nearly one-third of new HIV infections and AIDS death globally (www.unaids.org), young women are more than three times as likely to be infected as young men. This underscores the importance of developing prevention strategies that young women can use to protect themselves from HIV infection. Approaches based on the new research may help meet this need.

In the current work, the research group first tested the safety of daily vaginal applications of GML for six months in a group of rhesus macaques and found no side effects. Nine monkeys received a warming gel with GML added and three monkeys received the warming gel alone as a control.

The next step was to test the effectiveness of GML against the primate virus. Two animals with a warming gel plus GML and two with the warming gel alone were exposed vaginally to high doses of SIV, and then re-exposed to the virus. They continued to receive daily doses of the active and placebo gels. As a result, both of the GML-treated animals were completely protected from acute systemic infection. One of the placebo-receiving monkeys, however, became infected with SIV.

The researchers followed up by repeatedly exposing three additional GML-treated monkeys and three control animals to the virus over a period of weeks. Again, GML-treated animals were spared from acute infection, but all three in the control group became infected.

The lead investigator is Ashley Haase of the University of Minnesota. Collaborators include Jeff Lifson, M.D., head of the AIDS and Cancer Virus Program Directorate, and Jacob Estes, Ph.D., ACVP;and researchers from the Wisconsin Primate Research Center.Ceres Nanosciences and SAIC-Frederick Collaborate
On Cancer Steroid Hormone Studies

And a recent Press Release last week:

FREDERICK, Md., April 22, 2009 – Ceres Nanosciences, LLLP, and National Cancer Institute contractor SAIC-Frederick, Inc., a wholly owned subsidiary of Science Applications International Corporation (NYSE: SAI), have signed a collaboration agreement to assess Ceres’ nanotechnology-based system that can isolate scant amounts of substances in body fluids, with an eye toward developing tools for diagnosing cancer at the earliest possible stage when treatments are most effective.

Under the agreement, SAIC-Frederick laboratories will begin by assessing Ceres’ Nanotrap^TM technology in an effort to identify from body fluids extremely low concentrations of steroid hormones.

The agreement was formed under the National Cancer Institute’s Advanced Technology Partnerships Initiative (ATPI), which aims to further NCI’s mission by rapidly translating the results of basic research into new tests and treatments for cancer patients. SAIC-Frederick, as prime contractor at the National Cancer Institute at Frederick, is facilitating ATPI partnerships for the government.

“The role that steroid hormones play in cancer continues to be a research area of great interest,” said Timothy Veenstra, Ph.D., Head of Laboratory Proteomics Analytical Technologies at SAIC-F. “Our intent in developing the Ceres Nanotrap^TM is to increase the speed and accuracy with which samples can be processed and analyzed. This will lead to a better understanding of the role that steroid hormones play in cancer.”

“This collaboration with SAIC-F is an ideal match for Ceres,” said Ross Dunlap, Chief Operating Officer of Ceres Nanosciences. “It is aligned with our mission to develop an integral technology for more efficient and effective sample processing and disease diagnosis. We are very excited to partner with Dr. Veenstra’s team in support of the cancer research programs at SAIC-F.”

Ceres’ Nanotrap^TM technology is a nanoparticle platform developed to better capture low-abundance biomarkers and protect them from degradation. The Nanotrap^TM collection process, coupled with existing clinical diagnostic platforms, has the potential of significantly improving efficiency, reliability, sensitivity and accuracy of a wide range of critical diagnostic processes. This may improve diagnosis of diseases, including cancer, at their earliest stages.

About Ceres Nanosciences, LLLP

Ceres Nanosciences, LLLP is a privately held company focused on the development of diagnostic products using its unique and proprietary Nanotrap^TM capture particle technology. Ceres’ business goals are to develop a number of commercial applications of the Nanotrap^TM for high-demand diagnostics and other needs in the life science industry.

About SAIC-Frederick

SAIC-Frederick, Inc., a wholly owned subsidiary of Science Applications International Corporation (SAIC), a Fortune 500® company, is the operations and technical support contractor for the National Cancer Institute’s research and development center in Frederick, Md. This is a national laboratory dedicated to rapidly translating basic research into new technologies for diagnosing, treating, and preventing cancer and AIDS. SAIC-Frederick maintains a full suite of advanced technologies in areas such as nanotechnology, genomics and imaging; operates the federal government’s only drug and vaccine manufacturing facilities; operates the high-performance Advanced Biomedical Computing Center; and supports more than 300 clinical trials for patients in the United States and around the world.

Information about the NCI’s Advanced Technology Partnerships Initiative can be found at ATPIhome.com

Contacts:
Ross M. Dunlap
Ceres Nanosciences, LLLP
1.800.615.0418 ext. 202
rdunlap@ceresnano.com

Frank Blanchard (Contractor)
Director, Public Affairs
SAIC-Frederick, Inc.
National Cancer Institute at Frederick
Post Office Box B
Frederick, Maryland 21702
Phone: (301) 846-1893
Fax: (301) 846-1116
blanchardf@mail.nih.gov
http://www.saic-frederick.com

New Additions to FredCoBio Community

At the Ft Detrick Alliance tour last week, I was tipped off by Helen from FredCo-md.net (County Gov’t) that there were a number of new Biotech companies in the FredCoBio community.  Here’s the list:

Andromedex Corp. www.andromedex.com Andromedex specializes in helping independent pharmacies save money on their everyday items. From prescription pharmaceuticals to diabetic testing strips to health and beauty aids, Andromedex has savings to offer everyone.

BioProducts Maryland, Inc.  www.bioproductsmd.com BioProductsMD, LLC is a privately-held company located in historic, downtown Middletown, MD. Our company specializes in the development of new and exciting products that will have a major impact in the biotechnology and pharmaceutical industries. BioProductsMD is a new venture by Jeff Schubert, of Cell Trends fame. They list a number of ELISA assays and Integrase enzyme on their web site

Microbiology International www.800ezmicro.com Microbiology International specializes in autoclaves, peristaltic pumps, air samplers, anaerobic chambers, plate pourers, media preparators and stomachers as well as other automation equipment used in microbiological laboratories. We also provide laboratories with the most innovative automation equipment as well as the highest quality rapid detection kits and consumable products for pathogen detection available worldwide.

Bluepoint Bioscience www.bluepointbioscience.com distributes infectious disease diagnostic products to the clinical market. Our products include immunoassay based kits. Additional assays are developed per each client’s request, and include assays that use enzyme and fluorescence based detection platforms.  Looks like they’re sharing space with Marligen in Ijamsville.

Fisher BioServices www.fisherbioservices.com (no information currently available on their web site)

Sustainable Bioresources, LLC www.sustainablebioresources.com We are an early stage company in Frederick, Maryland conducting research and development of new cultivars for sustainable production of threatened plant species that are of economic interest.

And one I will add to the list is Kempbio www.kempbioinc.com a new company with a solid foundation in the bioservices industry. Our scientists have been serving the biopharmaceutical research community for over 15 years with quality cell culture and protein expression services. As we begin Kempbio, Inc. we are focused on technologies that we have mastered and we offer high-quality services to meet your research needs.  Kempbio is here in the incubator with me at FITCI@Hood.  Kempbio is a new venture by Chris Kemp, who is well know in FredCoBio for the former Kemp Biologicals, PGC Scientific and Gene Choice.

On a related note, looks like there is going to be a Job Fair of sorts at FCC’s Advanced Workforce Training Center, 200 Monroe Avenue, Frederick on April 22.  They’re calling it a ” Green Career Fair and Expo”.  I’m not sure if that because they’re environmentally conscious, that there are Big Bucks involved or that so many of us in FredCoBio have been recyled through the mulcher like compost throughout our careers?

Ft Detrick trip report

The tour of Ft Detrick (hosted by the Ft Detrick Alliance) on Thursday was enlightening, although it was about the nicest day of the year and I was stuck on a tour bus or in a conference room from noon until 5 PM.

The first stop was with the 21st Signal Brigade. There was an interesting “briefing” (could call it a “longing”, but this might imply you want to hear more) and they do a lot of neat stuff from Frederick:  the Hot Line between White House & Kremlin, responsible for all Presidential Communications and Secret Service, Medical communications,   Site R, etc.  And the Satellite Farm is pretty cool, too.  I think the largest has a spam of 78 feet.  Expect a few new additions in the next couple of years.
From there we had an informative visit at the USDA’s Agricultural Research Center’s Foreign Disease-Weed Science Research Unit. From their web site

Research focuses primarily on new or emerging plant pathogens which are not yet established in the U.S. and which must be kept under containment. Studies include 1) identification and control of pathogens which pose a potential threat to American agriculture and 2) use of foreign pathogens for biological control of introduced weeds. Primary objective of the research on disease threatening pathogens is to develop accurate methods for rapid identification and exclusion. The unit also assists in developing controls to compromise the impact of the disease, if established. The primary objective of the weed biocontrol research is to find pathogens not present in the U.S. but which are keeping the target weed under natural control in it’s native habitat. Studies are conducted on molecular and pathological characterization to assure safe release. The overall goal of the weed research is to support sustainable agriculture by assisting American agriculture in eliminating it’s reliance on chemicals for control of weeds. Research is conducted in support of other U.S. Government Agencies that require containment or which need assistance in answers to emergency situations concerning new diseases.

Interesting fact is that this is the largest BL3 level plant containment facility in the world with (I think) 27,000 sq feet of greenhouse under glass. Double insulated glass, white washed to prevent solar heating and cooling. The facility requires a tremendous amount of air handling to maintain temperature and humidity. So, ironically, the Greenhouse is not “Green” at all.  But the work they do saves millions and million of acres of crops every year and the research projects can take 20-30 years to complete.

The Last stop on the tour was at TATRC (Telemedicine & Advanced Technology Research Center).  They are doing research of the future.  I was hoping to hear about the Army’s Institute of Regenerative Medicine, but I did get to hear and seee a number of other cool projects.  There were talks about the Advanced robotics and Autonomous Casualty Care Programs, including the BEAR (Battlefield Extraction-Assist Robot) and Advanced Prostetic research.  There are a number of links on the TATRC web site to videos they showed us, but I cannot figure out how to make them work.  perhaps I am not advanced enough?

We also were given a copy of the TATRC Annual report, highlighting all of the programs (many of them not listed on the web site).   These include a suite of sexy, biotech programs like Medical Imaging Technologies that will permit portable sonography and remote diagnosis, a wide array of Infectious Disease research, research on Blood Safety & Supply, Neuroscience, Regenerative Medicine, Traumatic Brain Injury and Nanomedicine.

So the Fort grows and grows.  As mentioned in by the Frederick News-Post over the weekend, There are plenty of Jobs Available at Ft Detrick.  You can find some of them HERE.  Like most job hunting, if you know someone on the inside, I encourage them to ask for their help in getting your application into the right hands.

Looks like a busy day for me tomorrow, but I’ll try to throw up some new, new FredCoBio biotech companies I have heard about.  I’ll bet some of them are hiring, too.

Tour of the Fort

I am looking forward to a tour of Ft Detrick, exclusive for members of the Ft Detrick Alliance, tomorrow.  According to the Alliance web site, it is an “unprecedented tour of Fort Detrick.”  Don’t know what that means, but I hope we get a walk-through of the new NBACC facility. The next big Alliance event is a tour of the Riverside 5 SAIC facility in June.

And speaking of news from the fort, I was reading a very interesting piece yesterday about a proposal from NCI-Frederick for a new form of Clinical Trial they’re calling “phase O (Zero)”.

NCI (including NCI-Frederick researchers) have worked out a deal with the FDA to explore this phase O trial on a new cancer drug compound.  The phase O trials will involve a very small n umber of patients and use very low dosages of the compound of interest.  The purpose is to determine if  it is possible to enroll a small number of patients, treat them with a low dose of a new drug, identify whether the desired target of the drug was affected, and obtain all of this critical information relatively quickly.  The key point being small number of patients and rapid results = Saving BIG $$$.  Also, not advancing a compound into phase 1 trial that is going to fail is a big winner.

And in other news reported by FNP yesterday, a civilian Computer Scientist will receive a Arthur S. Flemming Award, recognizing him as an outstanding government worker. Jaques Reifman “leads a team of computer experts who have developed software for predicting physiological effects, identifying the DNA “fingerprints” of pathogens and searching databases of chemical compounds’” as reported by the Frederick News-Post.

I’ll take notes tomorrow and try to let you know on Friday if I see anything else intersting at Ft Detrick!

AFAB Labs, LLC: A Warehouse full of Used Goods

It just occurred to ma that many of you out there may be looking for some lab equipment, but need to mnd your budgets.  I may have a deal for you, AFAB Labs LLC.  I’ve been working with them to stock my lab here in FITCI.  Although they don’t have the slickest web site, I can tell you they have a warehouse full of used equipment. I have taken a number of people in the incubator system through their warehouse, and have also hooked up a bunch of my friends in the DIYbio community with gear.

They have a lot of electrophoresis units, scales, stirrers, whole fermentation skids, chromatography columns, pipettes, and pH meters galore.

So if you are looking for some gently used lab gear at better than eBay prices, I suggest to contact them. If you’d like a personal introduction on more information, you can always bug me if you want to.

And don’t forget to tell them you want the FredCoBio discount.

Weekend Update: Shroom hunting starting off slowly

I was hoping this weekend would be better for morel hunting after the rains yesterday. I think it’s still too cold at night and maybe we need a bit more than the inch of rain we picked up Friday into yesterday afternoon.

I did find a nice bunch of Oyster mushrooms on a downed Tulip tree.  I also found some interesting little organge/brown capped gilled ‘shrooms that have tantalizing me.  I’m not certain I have identified them correctly, so I went down this morning and collected 8 of them:

Click on pick for slide show

I am pretty sure this is the Deadly Galerina, Galerina autumnalis. According to the National Audubon Field guide, 10 hours after ingestion expect vomiting & diarrhea, cramps then a short remission followed by kidney and/or liver failure, coma and death.  Then again, it could be edible and it’s Easter.  I think I’ll pass and wait for the morels.

Catching Up

I’ve been busy in the lab the past couple days and haven’t had a chance to update an number of interesting stories I’ve stumbled across.  First things first.  you all need to be reprimanded for being Web 2.0 phobic.  Thus far, only 6 people have signed up on the FredCoBio Google Group.  Shame on you.  What are you waiting for, Christmas? Sign up here by selecting the “Join This Group” mouse over in the right column.  In all fairness, this is partially my fault since I didn’t have things set up correctly in the first announcement.

Now on to some interesting news.  As reported in the Frederick News Post, in the Gazette and then picked up by a number of other News feeds, Life Technologies won a $250,000 from the Governator and will be adding at least another 50 jobs in Frederick.  this at a time when Osiris is paring back in Columbia and other non-bio groups are laying off in Frederick.  I am so glad to see Life Tech is getting everything back on track.

In a very significant report I was reading this morning, Qiagen (HQ in the EU with facilities in MoCo) has come out with a $5 HPV test that will likely save millions of lives in the developing world. This effort was funded, in part, by the Bill & Melinda Gates foundation.  I know this is directly FredCoBio, but only the most dedicated reader will recall that the first generation of this HPV test is what brought yours truly to the Free State.  The Old Molecular Diagnostics Division of Life Technologies chaperoned the HPV test through FDA approval and I am proud to have participated in the effort.  unfortunately, this was in 1989 and it’s taken nearly 20 years for this test to find a significant market for growth and the good science to back it up.  There are even some who believe this was the first DNA diagnostic test approved by the FDA and most of it was done by Frederick Countians.  We knew 20 years ago this test would eventually replace the Pap smear and this may finally be the straw that breaks the Pap smears speculum.

In other interesting news, the NCI has announced Priorities for Stimulus money spending over the next couple of years.  It is not specifically stated in the article, but these priorities are certain to shape the way the new NCI-Frederick at Riverside Park is going to be deployed and I can’t wait to see the results.

And finally, an interesting publication from NCI-Frederick in the April 7th issue of the journal Cancer Cell.  NCI-Frederick researchers, working with a team from the university of Maryland show that expression of RNF6 was increased in human prostate cancer tissues that do not respond to androgen ablation and is required for prostate tumor growth under androgen depleted conditions.  In plain English, this may result in a significant breakthrough i the treatment of advanced prostate cancer.