From Frederick to Belgium

I am always on the lookout for publications in recent journals from local sources, like groups at NCI-Frederick and other local companies. If you know of any and would like to publicize your publication, just drop me a line and let me know.

Looking for something entirely different, I came across this recent publication in the ILAR Journal:

It is a comparison by GSK-Belgium of different in vitro systems for MAb production and prominently features local company FiberCell Systems. They conclude that FiberCell’s HF system is a suitable replacement for tradition in vivo systems. That means many a nude mouse is spared in every MAb production run, as MAb are traditionally produced by inducing a renal (kidney) tumor in mice and extracting the ascites (tumor fluid). I probably shouldn’t be posting this over lunch.

Anyway, a few select excerpts from the article:

Industrial Implementation of in Vitro Production of Monoclonal Antibodies

Vincent Dewar, Pierre Voet, Françcoise Denamur, and Jean Smal

Vincent Dewar, Pierre Voet, M.S., Françcoise Denamur, B.S., and Jean Smal, Ph.D., are members of the Scientific Staff of GlaxoSmithKline Biologicals, Rixensart, Belgium.

Abstract

Monoclonal antibodies are widely used at GlaxoSmithKline Biologicals (GSK Bio) for the quantification and characterization of antigens and for the release of vaccine lots. In 1998, GSK Bio decided to change the production of monoclonal antibodies (MAbs) designed for immunological tools from in vivo to in vitro technology. In 2004, all MAbs used at GSK Bio were produced in vitro. These MAbs cover more than 100 different targets with a variety of 1500 hybridomas, and approximately 60 to 90 MAbs are produced every year. This article describes the development process, including a description of the different systems tested based on double membrane or hollow fiber technology. The productivity, assets, and drawbacks of the different technologies are presented, and evaluation strategies for the choice of in vitro systems are discussed. Binding kinetics displayed by MAbs produced in vitro and in vivo were found to be similar, and MAbs produced in vitro are suitable tools for various immunological applications.

FiberCell.The FiberCell^TM (Fibercell Systems Inc., Frederick, MD) hollow-fiber cell culture system is composed of a culture medium reservoir (250 mL) and a 60-mL fiber cartridge (1.2 m²), both connected to a single microprocessor-controlled pump (Fibercell^TMsolo pump). It is possible to prolong the media supply cycles by replacing the original medium reservoir with a 5-L flask. In contrast to the Cell-Pharm® systems, the FiberCell^TM bioreactor is used inside a CO₂ incubator. Oxygenation occurs by a gas-permeable tubing.

Optimal inoculation of the system requires 400×10⁶ cells. One to two FiberCell^TM bioreactors together with the pump and the media reservoir can fit into a standard 180 L CO₂ incubator. Operation requires mid-level cell culture skills and a moderate investment. Production capacities, handling, and investment make the Fibercell^TM system suitable for routine MAb production units.

Discussion

During the introduction of in vitro methods for production of monoclonal antibodies at GSK Bio, the suitability for a given application was tested with each batch of MAb produced by in vitro technology and compared with that of MAbs produced by ascites tumors. New hybridomas generated after 1999 did not undergo such comparative analysis because the ascites tumor technology had been almost fully replaced by in vitro technologies. We report herein on our experiences with sp2/0-derived hybridoma cells cultured in various bioreactor systems. MAbs produced in vitro displayed similar binding kinetics to MAbs produced in vivo, and they were found be suitable tools for 12 different immunological applications (data not shown), including ELISA, Western blot, immunohistochemistry, affinity chromatography, FACS, as neutralizing antibodies, and in bactericidal or opsonophagocytosis applications.

A key factor for the choice of the appropriate in vitro bioreactor is the production capacity of the system, which must meet quantitative requirements at an affordable price. Concentration of the antibodies in the production medium is important when a small liquid volume is required to reduce the time needed for further purification. In addition, the concentration of MAbs obtained with a system should be applicable to immunological applications. It is also important to consider requirements for laboratory space, supplementary material, and technical expertise. Systems that operate outside an incubator save valuable space that can be allocated to alternative cell culture activities.

The productivity of an in vitro system depends on several variables, the most important of which are the culture conditions and the hybridoma cell line inoculated. For example, to achieve production quantities of 250 mg with low secretors (≤ 30 mg/mo; 250×106 cells), it is not advisable to use a suspension system due to the significant manpower and time requirements of that system (for adequate multiplication of the systems). In such cases, a more complex bioreactor that is based on hollow fiber technology is preferable for an economic production-to-investment ratio, despite the high starting costs and media consumption. Suspension systems are more appropriate for small- to medium-scale productions with hybridomas that are characterized by medium to high MAb production capacity (>30 mg/mo, 250×106 cells). In our laboratory, many laboratory-scale productions ranging from 10 to 150 mg have been successful using miniPERM or CELLineTM 1000, a system that requires little space and is easy to handle. Tecnomouse (1 cassette) and FiberCellTM (60-mL ECS cartridge) have been very convenient for productions ≥ 150 mg. CP100 was also suitable for medium-scale productions but at a higher expenditure in terms of preculture of hybridomas and set-up of the bioreactor. Although the Tecnomouse at its full capacity (5 cassettes) has not been tested, the most appropriate system for antibody productions beyond 500 mg has been the CP2500. It is advisable for a laboratory that is specialized in MAb productions to adopt several different in vitro methods to meet different needs.

Conclusion

In vitro bioreactor systems are a viable alternative to murine ascites for laboratory-scale MAb production. Various in vitro culture systems exist that are qualitatively equal to the ascites production method. It is generally accepted that in vitro production of MAbs is preferable to producing antibodies in ascites tumor cells (NRC 1999). Members of an official ethics committee might justify the use of the ascites method as an exception when, for example, hybridoma cells must be recovered because they have failed to grow in vitro, they have become infected, or the antibodies are needed for established therapeutic purposes. The existence of validated in vitro replacements for ascites in rodents has prompted governments in Europe to impose full or partial bans on animal-based MAb production. Although the in vitro MAb production technologies are more complex than in vivo ascites methods because they require additional cell culture, they have the clear advantage that animal pain and distress are avoided.

Ft Detrick Spring Research Festival

Just a reminder that the Annual Spring Festival is being held again this year at the Fort on Wednesday and Thursday this week (May 14th & 15th).

The event is open to the public, you just need to tell the armed guards ou’re going to the Spring Festival or the “Tent Show”.

If you’ve never been there, it’s definitely worth a couple hours time, either chatting with the vendors or Poster presenters. This year appears to be unusual because it seems like every year there is either torrential downpour, oppressive heat and even worse, both in combination. Standing in that tent is not pleasant in 100% humidity and 100 degrees.

I also like the theme this year: The Cancer Tree. They will be giving out free seeds, although it appears you’ll have to be a presenter or a exhibitor.

Here’s the story on the tree:

The Cancer Tree (Camptothecaacuminata)Our Spring Research Festival tradition is to choose something found in nature—plant or animal—that produces substances shown to have biochemical activity in fighting or preventing disease. In past years, we have featured the rosy periwinkle of Madagascar, Catharanthus roseus , the marine cone snail, Conus textilis, the African clawed frog, Xenopus laevis, the honeybee, Apis mellifera, and the gila monster (Heloderma suspectum and H. horridum). The “Cancer Tree,” a member of the tupelo family, is known by several additional non-scientific names: the Happy Tree and the Tree of Life. Those names are honestly earned. This is the tree that gave us the anticancer compound camptothecin, a substance found in the tree’s bark. The resulting drugs, topotecan and irinotecan hydrochloride are useful in treating breast cancers, ovarian cancer, colon cancer, malignant melanoma, small cell lung cancer, thyroid cancers, lymphomas and leukemias. The compounds, which have antiviral as well as anti-tumor properties, are also used for the treatment of AIDS. In 2002, the FDA approved another compound similar to topotecan as second-line therapy for certain cervical ovarian and lung cancers. The new compound, through regulating gene expression, can block growth of blood vessels that tumor cells need to survive. The tumor, deprived of its blood supply, can then shrink and die. The National Cancer Institute’s Developmental Therapeutics Program is responsible for the find. Giovanni Melillo, MD, together with colleagues Robert Shoemaker, PhD, and Nick Scudiero, PhD, devised a high-throughput screen for 2,000 compounds and found three other effective compounds in addition to the topotecan analog. The Cancer tree is native to China, growing up to 75 feet tall in warmer climates. In climates such as Maryland, the tree is easily grown from seed and can be kept indoors with ample warmth and bright light, when pruned to manageable size. The Spring Research Festival organizers, in a nod to both the cancer tree and to fostering biodiversity for the sake of research have ordered a supply of Camptotheca acuminata seeds, and will be awarding them to Festival participants. The recipients will receive instructions along with their botanic treasures to ensure that both have the best chances to live long and prosper.

USAMRIID Teams with Hopkins for Graduate degree at Ft Detrick

This looks like a pretty good opportunity for our “younger” readers out there.  The Job Search page continues to be one of the most popular on this site and I often wonder how many of these inquiries are from recent graduates?

In any event I saw a brief note in the FNP today and then pulled the original press release from Hopkins web site.  Here’s the skinny:

JHU Biotech Program, U.S. Army Enter
Collaborative Relationship
Agreement will expand educational opportunities in
biodefense research field

The Johns Hopkins University and the U.S. Army have agreed to work together to train scientists to develop vaccines and medicines to defend against biological attacks.

Students accepted into the program will study part-time to earn Johns Hopkins Master of Science in Biotechnology degrees with concentrations in biodefense. Simultaneously, they will work for the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), located at Fort Detrick, Md.

Under a five-year agreement between Johns Hopkins’ Advanced Biotechnology Studies Program and USAMRIID, graduate students will be employed under the Army’s Student Career Experience Program and will be eligible for Army reimbursement of their Johns Hopkins tuition.

“Based on a long history of excellence in biotechnology research and education at both institutions, this is an invaluable cooperative effort that will significantly enhance the educational opportunities of our biodefense students,” said Richard McCarty, chair of the Advanced Biotechnology Studies program in the university’s Krieger School of Arts and Sciences Advanced Academic Programs. “We hope it will lead to future interactions and joint scientific research between our respective faculty and scientists.”

Johns Hopkins advisors will work with students to select an appropriate course structure that will capitalize on the resources being offered by USAMRIID, such as research staff and laboratory facilities.

USAMRIID does basic and applied research on biological threats to develop vaccines, drugs and tests to protect soldiers, but much of the science it produces is also applied to civilian medicine.

“USAMRIID is very excited about sponsoring these master’s students and offering them the opportunity to work at USAMRIID on vaccines and therapeutics against extremely interesting pathogens,” said Peter Hobart, USAMRIID’s science director. “This is one more manifestation of the institute’s keen interest in working closely with colleges and universities to train the next generation of scientists.”

About the Advanced Biotechnology Studies part-time Master of Science in Biotechnology Program: Grounded in biochemistry, molecular biology, and cell biology, this program allows students to delve into pure science, applied science, lab science, regulatory affairs, and biotechnology enterprise. They can pursue a general master’s in biotechnology or focus on one of three concentrations that are available fully online: bioinformatics, biotechnology enterprise, or regulatory affairs. Concentrations in biodefense and molecular targets and drug discovery require some on-site instruction.

For more information about Johns Hopkins’ part-time graduate degree available through the Advanced Biotechnology Studies Program, please visit biotechnology.jhu.edu or contact our academic advisors:

Patrick Cummings, Senior Associate Program Chair Biotechnology 410-516-4724; cupat@jhu.edu

Dr. Kristina Obom, Associate Program Chair Biotechnology/Bioinformatics 301-294-7159; kobom@jhu.edu

Lynn Johnson Langer, Senior Associate Program Chair Biotechnology (MS/MBA, Bioscience Regulatory Affairs, and Biotechnology Enterprise) 301-294-7063; ljlanger@jhu.edu

IVGN announces Licensing deal with WARF

According to their web site today, Invitrogen has signed an agreement with Wisconsin Alumni Research Foundation (WARF) for Human Embryonic Stem Cells.

According to the release:

Under the terms of the agreement, Invitrogen will have the right to work with karyotypically normal hESCs to develop novel research and drug discovery tools.

“Invitrogen’s goal is the development of research tools that enhance the ability of scientists to work with embryonic stem cells and to enhance the utility of these cells for research and drug discovery,” said Joydeep Goswami, Vice President, Stem Cells and Regenerative Medicine. “Having the ability to work with karyotypically normal hESCs through our license with WARF allows us to develop better technologies for research, such as more defined media and engineered stem cell lines. This agreement is another step in our strategy of pursuing advances in the high-growth area of regenerative medicine.”

This is interesting in several regards.  WARF appears to be holding it’s own in defending several patents related to hES cells, although the verdict is still out.

Perhaps more interesting is that IVGN’s RegMed group is, I believe, in Frederick.  At least Dr Rao, who is also a VP of the Stem Cell Group, is in Frederick.

OncoVAX Authorized by Dutch

In a press release yesterday, it was announce that Frederick-based Vaccinogen’s potential blockbuster colon cancer “vaccine” therapy has been approved for manufacture at their Emmen, Netherlands facility.

From the FoxBusiness web site:

FREDERICK, Md., May 7, 2008 /PRNewswire via COMTEX News Network/ —-Vaccinogen Inc. said Dutch health authorities licensed it to manufacture its break-through OncoVAX anti-colon cancer vaccine, immediately clearing the path to more than $100 million of potential European sales.

The Dutch approval of the company’s facility based in Emmen, The Netherlands also paves the way to its pivotal US FDA Phase IIIb clinical trial — the final step before the vaccine can be sold in the United States.

“The facility can produce up to 3,500 vaccines annually, equivalent to $130 million in revenues,” said Michael G. Hanna, Jr., Ph.D., Vaccinogen CEO. “That number only scratches the surface of potential demand for a Stage II colon cancer vaccine. One of every three patients who have their cancer removed see it return — and the results are usually fatal.”

“Our experience with OncoVAX has resulted in increasing the patients’ chance of survival by more than 50%,” he concluded. “This represents an opportunity for a new lease on life for tens of thousands of patients around the world.”

The Dutch license permits the company to commercialize the vaccine, first in Switzerland and then in seven other countries in Eastern Europe. The OncoVAX vaccine represents a potential medical breakthrough because it uses a patient’s own cancer cells to prevent the cancer from returning after a successful operation to remove it.

The product is actually not a standard “vaccine” like you’d get for rabies or HPV or influenza.  These vaccines are produced and tested in large batches in fermenters and everyone gets essentially the same dose.  OncoVAX is actually an autologous vaccine, whereby a small section of the excised tumor is sent by the surgeon to the production facility where the tumor section is processed and made antigenic.  It is then injected back into the patient, where their own body produces antibodies to the tumor and kills it.

While Vaccinogen is not the only company working on this new era of “personalized medicine”,  they are among the first to pave the way through clinical trials.  This explains, in part, the extreme effort (in terms of $$ and time) it has taken to get this novel process through the rigors of FDA approval in the States.

There’s No Place Like Home

I was remiss in not posting that FITCI hosted the first of the Season Happy Hour & networking event on Friday. I had been in Kansas since Wednesday and was too busy working on my presentation and dodging tornado’s to post. Plus, I forgot to look ahead in my calendar.
The Happy Hour was well attended, by the Chamber of Commerce, RCM&D, OED, Ft Detrick’s tech transfer office and many other people I didn’t have the chance to meet & greet. I had only been back for about an hour, though, from my trip. Since I had to get up at 4 AM to get to the airport, I was pretty exhausted by 4 PM and the happy hour, so I didn’t stay long.

I stopped in to feed my cells, but ended up getting a Biodiesel sample for testing, so I did that instead, then got myself home.

Speaking of events, I will be out at the Greater Baltimore Tech Council’s Golf Classic on Monday May 19th and AFCEA Frederick’s Golf outing Tuesday May 13th at Whiskey Creek. The GBTC event is “SOLD OUT”, but there is still room for both individual golfers and Sponsorships at the Frederick event.

1st Annual AFCEA Golf Tournament Come Join Us Prior to the Spring Research Festival Where: Whiskey Creek Golf Course When: May 13th - 1 pm Shotgun Contact Abby Richon to sign up or become a sponsor 301-644-3913 x2178 arichon@ape-bio.com This e-mail address is being protected from spambots, you need JavaScript enabled to view it <!– document.write( ‘</’ ); document.write( ’span>’ ); //–>

Lunch Complementary Beverages on the Course Dinner Silent Auction Hole-In-one Contests Great Networking $100 per government golfer $125 per industry golfer

Click here to download PDF for available sponsorships

APE-BridgePath Merger announced

This press release came out today through the PRWeb:

Local Biotech Companies Merge Operations

Advanced Product Enterprises and BridgePath Scientific become APE-BridgePath Scientific

Frederick, MD (Vocus/PRWEB ) April 29, 2008 — The Baltimore-Washington metropolitan region is a productive R&D arena, with over $7 billion spent each year on scientific products for research and product development. Two local companies catering to the same target market, but with different niches, have teamed up to offer a spectrum of services to commercial, academic, and governmental research organizations.

Dr. Joseph Garner (left) and Patrick Haley have merged as APE-BridgePath Scientific, providing solutions for research and development institutions.

I couldn’t be more pleased with this merger. The combination of the two companies will allow us to serve the biotech industry at-large in a more cohesive manner

BridgePath Scientific and Advanced Product Enterprises, LLC (APE) of Frederick have merged their operations into APE-BridgePath Scientific. “Both companies are currently headquartered at the Frederick Innovative Technology Center incubator,” stated Dr. Joseph Garner, President and CEO of APE. “We have collaborated on a number of projects, and joining the two companies will provide our clients with a complete list of value-added services from one organization. We believe the addition of highly trained and business minded scientists to the product lines sold by BridgePath, will allow APE-BridgePath Scientific to provide a high level of understanding and technical support to commercial, academic, and governmental researchers that is currently lacking in the industry.”

“I couldn’t be more pleased with this merger. The combination of the two companies will allow us to serve the biotech industry at-large in a more cohesive manner,” stated Patrick Haley, President and CEO of BridgePath Scientific. BridgePath Scientific provides scientific and laboratory equipment, supplies and custom research and development product fulfillment. They carry tens of thousands of products. Founder, President and CEO Patrick Haley is an active member of the Frederick community and the State of Maryland. He has served on many business, community, industry, and civic boards and councils, including the Technology Council of Maryland, Goodwill Industries of Monocacy Valley, and the Suburban Frederick Kiwanis Club. Haley is a long time member of the Business Development Advisory Council (BDAC) for Frederick County, currently serving as Chairman, and the Frederick chapter of the Armed Forces Communications and Electronics Association (AFCEA). He is also co-founder and former Chairman of the Board of the Frederick Innovative Technology Center, Inc. (FITCI), Frederick County’s first technology incubator.

Advanced Product Enterprises, LLC provides preclinical contract research for pharmaceutical and vaccine companies along with several scientific research products. Their founders of APE have over 30 years of academic and industry research experience and recently launched APE Biodiesel, providing complete testing for biodiesel fuels. Dr. Joseph Garner, President and CEO of APE, was trained and received his PhD in molecular biology at the University of Maryland and studied at the Center of Marine Biology. He is active in a number of regional and national organizations, including the American Society for Pharmacology and Experimental Therapeutics, the American Society for Biochemistry and Molecular Biology, and the Business Development Advisory Council for Frederick County. Dr. Garner has presented research worldwide at scientific meetings, including Translation UK in Dundee, Scotland and International Marine Biotechnology Conference in Australia.

APE-BridgePath is located in the Frederick Innovative Technology Center’s second incubator located at 4539 Metropolitan Court in Frederick, Maryland. For more information about the company and their services, visit www.bridgepathscientific.com and www.ape-bio.com or call 1-888-496-8333.

In vitro models for human skin Tox studies to be made in Frederick

The news keeps coming in for LifeLine, in Walkersville. I was doing research for another project and saw this on their website today:

International Stem Cell Corporation Obtains Exclusive Rights in the US and Canada to Distribute Approved Human Skin Model for Toxicity Testing

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OCEANSIDE, California, April 29, 2008

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International Stem Cell Corporation (OTCBB: ISCO) announced today that it has entered into an exclusive agreement with CellSystems Biotechnologie to distribute laboratory-cultured models of human skin useful for testing the hazardous properties of consumer products and for dermatological and pharmaceutical research. Such testing is likely to be soon required for certain types of consumer products sold into the European Union.

According to International Stem Cell’s (ISCO) President Jeffrey Janus, “This agreement is another positive step in ISCO’s strategic plan to become the primary source of high quality human cells for the therapeutic and research markets by leveraging its manufacturing and distribution resources.”

ISCO’s human cell and cell culture research products are manufactured and distributed under the “Lifeline” brand by wholly-owned subsidiary Lifeline Cell Technology, LLC, based in Walkersville, Maryland (www.lifelinecelltech.com).
The laboratory-cultured models of human skin, called EST-1000 and AST-2000 were developed by CellSystems and contain cells manufactured by Lifeline. These three dimensional skin cell models are used as alternative methods to animal testing in the field of Skin Corrosion, Skin Irritation, Skin Sensitization, Genotoxicity and Phototoxicity.

“We have worked with the Lifeline staff and know their abilities to provide excellent
customer service and their ability to consistently produce high quality products; a critical factor for researchers that depend on human cells for the success of their research,” said Horst W. Fuchs, President of CellSystems Biotechnologie. This agreement between our companies opens a distribution channel for CellSystems’ skin model products to scientific researchers throughout the United States and Canada.”
“While the sale of these Lifeline stem cell and research products provides ISCO
immediate cash flow, it also helps embed ISCO’s products into successful therapeutic and quality control procedures worldwide, providing a revenue stream of shared royalties beyond traditional sales,” added Janus.

Holy Cow!

Yes, I know this is supposed to be a blog about Frederick County Biotech. This story is neither about Fred Co nor biotech, but it’s my blog and I can rant when I want to.

I am at a loss for words. Hold on, they’re coming back to me. In waves, kinda like diarrhea. Maybe this can be my inaugural BPSDB post?

The Global Warming conspiracy, in Nature no less, reports that the ozone-hole recovery is threatening the Antarctic Ice cap. Yes brothers and sisters, the Ozone hole, so widely attributed to be the demise of the planet in the 80’s, a tell-tale, doomsday prophecy of humans ruining the universe due to gluttony and lust of chlorofluorocarbons and exhaust from burning of fossil fuels, the ozone hole shrinketh.

From the article ( a drum roll please):

Antarctic ice threatened by ozone-hole recovery

Global winds could accelerate melting.

Amanda Leigh Haag

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The ozone hole may have delayed Antarctic warming

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Recovery of the ozone hole above Antarctica could warm the Antarctic and cause more ice to melt in coming decades, researchers say. As the ozone hole heals, wind patterns that shield the interior of the polar region from warm air may break down, causing warming in the Antarctica as well as warmer and drier conditions in Australia.

Despite global temperatures rising, the interior of Antarctica has experienced a unique cooling trend during its summer and autumn over the last few decades. Scientists attribute this cooling to the hole in the ozone layer, which alters atmospheric circulation patterns and strengthens the westerly winds that swirl around the continent. These winds have isolated the Antarctic interior from the warming patterns seen on the continent’s peninsula and throughout the rest of the world.

“The warming of the Antarctic may have been delayed because of the ozone hole,” says atmospheric scientist Judith Perlwitz, a climate scientist at the of the University of Colorado at Boulder and the National Oceanic and Atmospheric Administration.

Let it be said, as real climatologists have been telling us for decades, there is no consensus that we are in a period of global warming. As this article supports, the Antarctic (the Southern Hemisphere in general) has been experiencing a “unique cooling trend”.

Sounds like we’re heading for an Ice Age, to me.

Ok. Rant accomplished. I hope my invite to SciFoo ‘08 isn’t retracted. I’ll overblog this with something good I just read about FredCoBio…

NCI’s Nanotechnology Characterization Laboratory

I ran across this article last week in medicalphysicsweb.com, so might as well post it. All kinds of news from the Fort this week:

Apr 15, 2008

A new take on MRI contrast

The US National Cancer Institute (NCI) has given the go-ahead for preclinical characterization of a nanomaterials-based contrast agent that’s being billed, at least by developers in industry, as “a completely new approach to enhancing contrast during MRI procedures”.

The modified fullerene compound comes from the labs of Luna Innovations, a Roanoke, VA-based technology-transfer company with interests in healthcare, telecoms, energy and defence markets.

Studies of the MRI contrast candidate will include characterization of its physical attributes, its in vitro biological properties and its in vivo compatibility using animal models. Researchers will also examine critical parameters related to distribution, metabolism, elimination and toxicity.

The study programme is expected to take a year from receipt through the in vivo phase. Evaluation will be carried out at the NCI’s Nanotechnology Characterization Laboratory (NCL) in Frederick, MD. The NCL’s remit is to standardize preclinical characterization of nanomaterials intended for therapeutic and diagnostic applications.

“The outcome of this characterization study is the report necessary for an Investigational New Drug application,” said Chris Kepley, nanoimmunology group leader at Luna and principal investigator on the study. “The process of getting a new drug to market can be a lengthy one. However, with the NCL behind us we hope to move forward more quickly bringing to market a next-generation solution for MRI contrast agents.”