At this year’s BioProcess International Conference, the 2014 BioProcess International Award Winners were announced. These awards recognize outstanding achievements in the area of biotherapeutic development and manufacturing processes. This year individuals and companies that made significant contributions to improving biotherapeutics were recognized. Novel technologies in upstream, downstream and analytical application areas were also awarded. I have listed the winners and finalists along with a brief description of the winning achievements.
Dr. Robert Preti created PCT to meet the growing need for high quality Cell Therapy manufacturing. PCT provides a Cell Therapy focused contract development and manufacturing organization with over fifteen years of experience in this field. PCT provides a solution to bridge the gap between laboratory discovery and clinical application in this rapidly growing therapeutic area. Dr. Preti now holds the position of President and Chief Scientific Officer and under his guidance; PCT has become a leader in Cell Therapy manufacturing. PCT has full-scale cGMP/GLP manufacturing operations and have manufactured more than 30,000 products. Their two locations in New Jersey and California enable bi-coastal distribution and delivery, a function critical to the success of several Cell Therapy applications.
In addition to his work at PCT, Dr. Preti is also a leader in many other professional organizations including his work with the International Society for Cellular Therapy (ISCT) and the Alliance for Regenerative Medicine (ARM). He recently completed a five-year term as a director for the American Association of Blood Banks (AABB) and has published and presented extensively on Cell Therapy related topics.
ToleRaM Nanotech is working to develop and market novel methods for combatting organ transplant rejection by utilizing nanocarriers to provide targeted delivery of anti-rejection drugs. They have proposed a way to reduce the negative effect of immunosuppressant therapies delivered during organ transplant by delivering these drugs using nanocarriers that target only the transplanted organ. Thus, eliminating the need for systemic delivery of immunosuppressants and the associated side effects including opportunistic infections and occurrence of cancerous tumors.
BioCision – develops products and solutions for process standardization throughout the healthcare industry with products that enable researchers, clinicians and manufacturers to protect the integrity of temperature-sensitive therapeutics, biological samples, and biomaterials.
Horizon Discovery – supplies research tools to organizations engaged in genomics research and the development of personalized medicines
Bayer HealthCare has consistently shown a strong commitment to corporate citizenship and the community to which they belong. When Bayer moved into their Berkeley location in 1992, they incorporated community assistance into their agreement with the city. Their commitment exceeded standard city development agreements by examining the needs of the community and working to make a positive impact. Bayer created a strategy that included resource reduction, recycling plans, auto use-reduction, child care, affordable housing, high-quality public education among others. This represented a tremendous commitment from Bayer and its employees with a financial investment of more than $20 million dollars.
Category – Excellence in Facility Design or Retrofit
Winner: Gallus BioPharmaceuticals and GE Healthcare Life Sciences
In 2011 Gallus BioPharmaceuticals, a contract development and manufacturing business, acquired a 27 year old manufacturing facility in St. Louis from Centocor. In just nine short months, Gallus and their partner in the redesign, GE Healthcare Life Sciences, had transformed this former pharmaceutical facility to a state of the art cGMP flexible manufacturing facility. The 8,000 square foot facility is designed for Phase I, II, and III clinical manufacturing of monoclonal antibodies and recombinant proteins. Key to the speed of operational readiness was GE Healthcare’s FlexFactory™ cGMP manufacturing platform suite. The FlexFactory with its extensive use of single-use technologies and advanced process control and data historian capabilities, permits a wide range of manufacturing processes, manufacturing lay outs and simplifies the steps necessary to product changeovers. This work obviously required a close collaboration between the two companies and congratulations to both.
To learn more about flexible manufacturing see – “Single-use Stirred Bioreactors – Enabling Flexible Biomanufacturing”.
As a result of this vendor-customer collaboration, Tap Biosystems and Merck developed a mini bioreactor system to simulate production conditions in traditional full-scale bioreactors. The system, called ambr250, allows for improved bioprocess development by permitting scientists to execute a statistical DOE for 24 single use bioreactors simultaneously. Thus providing a perfect opportunity to test a range of manufacturing conditions during process development with efficient scalability.
In a press release issued following the award ceremony, Mwai Ngibuini, ambr250 Product Manager stated: “The main aim of our collaboration with Merck was to develop a simple to set up, single-use mini bioreactor system which has the versatility to replicate traditional bioreactors and fermenters for culturing mammalian and microbial cells. To achieve this we listened carefully to the bioprocessing experts that would use the system, as well as the context into which it would be placed and then worked tirelessly to deliver their vision.”
This collaboration is a great example of the groundbreaking achievements that can be accomplished when vendors and customers work in close partnership. Congratulations to both Tap Biosystems and Merck.
Winner: ambr250 – Tap Biosystems and Merck & Co., Inc.
The ambr250 was codeveloped by TAP Biosystems and Merck & Co., Inc. (see discussion of collaboration above).
The ambr250 workstation offers parallel control of 12 or 24 single-use bioreactors with 100-250 ml working volume. The system mimics large-scale bioreactor production by providing a fully automated system with media fill, inoculation, sampling and feeding. It is also possible to have individual control of each mini bioreactor’s temperature, impeller speed, pH and DO, thus enabling testing of a wide range of manufacturing conditions in a scaled-down model. This system addressed an unmet need in biomanufacturing and continues to enable new advances in process development.
In the same post awards press release, Mwai Ngibuini, ambr250 Product Manager stated: “We’re delighted to win these awards with Merck because it indicates that the time and effort we all put into this partnership has really been worthwhile and the ambr250 is viewed by our bioprocess peers and experts as breakthrough technology, which has the potential to totally transform process development of antibody and protein-based therapeutics.”
Category – Best Technology Application – Downstream
Winner: Natrix HD Membrane – Natrix Separations, Inc. and Gallus BioPharmaceuticals
The Natrix HD membrane chromatographic separation technology employs a 3-D macroporous hydrogel that permits a high density of binding sites. It also uses advective flow rather than diffusion, which significantly improves flow rate and throughput. This combination of high-density binding and high throughput provides key process benefits, including the ability to accomplish manufacturing needs within a smaller footprint, a reduction in consumables, a reduction in labor and elimination of fixed glass columns. These benefits combined with its single-use design provide increased flexibility over more traditional column chromatography methods. The Natrix technology has demonstrated success with a wide range of molecules. Gallus employs the use of Natrix HD membranes in areas of their downstream biomanufacturing operations.
MicroScale Thermophoresis (MST) is an innovative way to look at biomolecular interactions. The system uses a combination of fluorescence detection with thermophoresis and measures the motion of molecules along microscopic temperature gradients detecting changes in their hydration shell, charge or size. Applications include small-molecule binding events, protein interactions, and interactions of multi-protein complexes.