Claudia Zylberberg-Cell Culturing Innovator

Taking You Cultures to New Dimensions

I am pleased to feature Dr. Claudia Zylberberg, President and CEO of Akron Biotech, in this edition of “News Behind the News”.  She is an expert and innovator in providing tools and methods for the discovery and development of cell based therapies.  This starts with potent cell based assays and culminates with the ability to provide GMP produced reagents to support animal testing and other pre-clinical trial drug discovery processes.

Scientist and Entrepreneur a Synopsis

Claudia has a background that uniquely positions her to understand and address the growing needs and requirements of the basic and drug discovery research community. This includes researchers using stem cells as for discovery and potential therapies. Here’s an overview.

With a PhD in Biotechnology from the University of British Columbia and University of Buenos Aires, Claudia has over 25 years of experience in the international biopharmaceutical industry.  At NABI Biopharmaceuticals, she and her team developed and scaled plasma-derived products and recombinant vaccines. This included harmonizing products between EMEA and FDA. She has authored and co-authored many scientific articles and developed several commercial products for use in the field of cellular biology. She has also authored a children’s book on genetics and has several patent pending products in the area of cryopreservation and QC of stem cells.

She is as an advisor for the US Pharmacopoeia in standards setting for biologics and ancillary materials critical for the production of cellular therapies.  She is a member of the BioFlorida Board of Directors, Board member of Business Development Board of Palm Beach County, Scientific Advisor for ISCT (International Society for Cell Therapy), Executive Committee Member for the Alliance of Regenerative Medicine and the Chair of the Business Advisory Board for the Banner Center of the State of Florida and is part of the organizing committee for the World Stem Cell Summit coming up in Palm Beach December 2012.

Excellence in Cell Based Assays

Excellent in cell based assays means lower research and development costs. There are two sides of the “cost coin”. On one side, if any of the raw materials (plates, cells, media, growth factors, markers, probes or detection, etc. are a weak link), the whole chain is destroyed and all time and material cost are wasted. On the other side, if culture conditions do not promote an environment enables in vivo like conditions, the data may prove to be unsupported in pre-clinical testing. This results in big costs in both opportunity and related expenses.

This is why Akron Biotech’s product and expertise are so important.  This is also why they could become important partners for Neuromics.  They have the ability to deliver a large cross section of the capabilities required for excellence in cell based assays. 

These capabilities include:

  • Best manufacturing practices (GMP) guarantee products will work as expected.
  • Delivery of tools and methods that support research from the bench to pre-clinical studies.
  • Product strategies that insure current and future fill known gaps in driving cell based assay excellence.

These includes:  media, growth factors, 2D/3-D culturing ECMS and Polyfibers, recombinant proteins and cryopreservatives.  Many fit hand in glove with my strategic offerings. I plan on continue to publishing update on new developments from Akron Biotech.

Nanofiber 3-D Cell Based Assays

This “News behind the News” is a historic event.  It demonstrates how nanofiber scaffolds can be used to engineer organs for human transplants. Good news for researchers looking solutions are in vivo like environments for cell based assays.

Nanofibers Solutions work in transplants-imagine how well they will work in your 3-D based cell based assays.

3-D Cell Based Assays for Drug Discovery are the future. Like any new model, adoption rates are a function of how well the new solutions works. “The proof is in the pudding”.

Here’re highlights of a historic event based on transplants using nanofiber engineered laryngotrachea : Collaboration between Nanofiber Solutions and the Karolinska Institutet produces first synthetic laryngotracheal implants seeded with the patient’s stem cells to be successfully transplanted into human patients in Russia.

COLUMBUS, Ohio, June 26, 2012 – Nanofiber Solutions, LLC, an Ohio-based developer, manufacturer and marketer of 3-D synthetic scaffolds to advance basic research, tissue engineering and regenerative medicine announced today the first and second successful transplants of its tissue engineered laryngotracheal implants seeded with cells from the patients’ bone marrow.

The surgeries were performed June 19th and 21st at the Krasnodar Regional Hospital (Russia) by Dr. Paolo Macchiarini, Professor of Regenerative Surgery at the Karolinska Institutet (Stockholm, Sweden), and colleagues. Dr. Macchiarini led an international team that included Dr. Vladimir Porhanov, head of Oncological and Thoracic Surgery at Kuban State Medical University (Russia), Dr. Jed Johnson, Nanofiber Solution’s Chief Technology Officer who created the synthetic organs, Harvard Bioscience (Boston, USA) who produced the bioreactor, and Dr. Alessandra Bianco at University of Rome, Tor Vergata, who performed mechanical testing during scaffold development.

Both patients, a 33 year-old mother from St. Petersburg and a 28 year-old man from Rostov-on-Don, were in au to accidents and suffered from a narrowing of the laryngotracheal junction for which they already had failed previous surgeries. Transplantation was the last option for the patients to have normal quality of life. Immediately following transplantation, both patients were able to speak and breathe normally.

Nanofiber Solutions, lead by Dr. Johnson, designed and built the nanofiber laryngotracheal scaffolds specifically to match the dimensions of each patient’s natural larynx and trachea, while Harvard Bioscience provided a bioreactor used to seed the scaffold with the patients’ own stem cells.  Although this procedure represents the world’s first and second successful use of synthetic synthetic laryngotracheal implants, it is Nanofiber Solution’s second and third successful organ implants using their synthetic scaffolds within the last year.

Nanofiber Solutions’ scaffolds mimic the body’s physical structure and allow for a more successful seeding, growth and differentiation of stem cells. Because the cells used to regenerate the larynx and trachea were the patients’ own, doctors report there has been no rejection of the transplants and the patients are not taking immunosuppressive drugs. (more).

Capabilities of 3-D nanofiber scaffolds for cell based assays:

Human brain tumor biopsy showing migrating tumor cells along the alligned nanofiber.
  • Nanofibers are optically transparent to allow for live-cell imaging and real time quantification of cell mobility using an inverted microscope
  • Nanofibers mimic the 3D topography found in vivo which produces a more realistic cellular response to therapeutics.
  • More realistic cellular behavior means you can use fewer animals and decrease time-to-market for drug discovery and development.
  • Nanofibers can easily be coated with ECM proteins using existing protocols for standard lab ware.
  • Cells can be easily removed for protein or gene analysis using trypsin, EDTA, etc.
  • We will continue posting relevant press releases, pubs and data that prove the capabilities of these important solutions.