Held in Long Beach, California, from October 31 to November 4, was the BioProcess International, a conference and exhibit organized by IBC Life Sciences. Focused on biologics manufacturing, the presentations for each day were grouped according to four tracks and largely featured case studies. For example, on November 1, the day IBO attended the show, one of the four tracks was “Analytical Technologies for Biopharmaceutical Development.”

IBO chose to attend the day’s two Strategy Discussion Forums, which were interactive discussions between industry leaders, regulators and audience members. The interactive format provided for an extended exchange of views and ideas on problems facing drug developers, manufacturers, regulators and technology providers. Tuesday’s morning session was entitled “Integrating New Technologies—Reviewing the Hottest New Technologies and the Challenges Faced when Implementing Them into Your Processes.” It featured executives from Latham BioPharm Group, Cook Pharmica, Acceleron Pharma, Pfizer, GE Healthcare Life Sciences and the FDA’s Center for Drug Evaluation and Research (CDER).

Providing a vendor’s point of view, Günter Jagschies, PhD, senior director of Strategic Customer Relations at GE Healthcare Life Sciences, highlighted the importance of collaborations between vendors and end-users, stating that collaboration is the mode of the future. But collaboration can also have its frustrations, according to one audience member, who recounted his company’s trial of a new technology only to discover a major problem with it, and the time and effort that his company expended in educating the vendor about its product.

The discussion also touched on how collaborations at a precompetitive level could benefit technology development. Dr. Jagschies supports a more open approach to intellectual property by pharmaceutical companies to facilitate technology development, emphasizing that a vendor’s resources to develop a technology are finite. Steven Kozlowski, PhD, director of CDER’s Office of Biotechnology Products, Office of Pharmaceutical Science, noted how a more open approach could facilitate technology adoption by enabling a small company’s technology to survive, even if the company does not.

Both panelists and audience members shared their thoughts on the dilemmas faced by small companies in bringing a new technology to market. The adoption of new technologies can be limited by a small company’s credibility. Making this point was an audience member who asserted that a common question he will ask before trying a new technology is “who’s done it before?” Another audience member from a technology company stated that the premium placed on standardization and cost control today has also limited the adoption of new technologies.

Economic considerations were also discussed. Mauricio Barraza, senior manufacturing manager at Acceleron Pharma, stated that biological manufacturing is more expensive than small-molecule manufacturing. He noted that, taken together, sometimes a series of small improvements to existing technologies can be more valuable than a new technology.

The role of developing markets in advancing new technology was also discussed. Dr. Jagschies noted although many drug companies in China and India want proven technology, new technology can often offer cost savings. Another influencing factor of the adoption of technology in developing countries is the willingness of some drug companies in such countries to accept lower profit margins. An audience member commented that the vaccine market was an area where the need for lower-cost manufacturing could drive technology innovation.

In his presentation, Dr. Kozlowski noted that it still takes a long time for new technology to be adopted, citing the example of capillary electrophoresis, which took 30 years to be added to the US Pharmacopeia. As an example of the FDA’s efforts in working with industry on the adoption of new technology by providing transparency and flexibility, he cited the 2004 Process Analytical Technology Framework.

The second strategy discussion forum IBO attended, “Global Advances in the Regulation of Biosimilars,” featured executives from biosimilar companies and regulators. Moderator Thomas J. Vanden Boom, PhD, vice president of Global Biologics R&D at Hospira, started the discussion by sharing IMS’s projections for the biosimilars market. In 2010, biosimilars accounted for only $311 million of the $138 billion global market for biologic drugs. In 2015, biosimilars are projected to account for $2–$2.5 billion of the $190–$200 billion market for biologics. He noted that the difference between the estimated sales for biosimilars in 2015 and the $70 billion of biologics that will be off patent by then will be the rate of adoption. He stated that the market for biosimilars can be characterized by one word: uncertainty.

Providing some insight into the relatively new market, Jay S. Stout, PhD, executive director of Biologics Manufacturing Services and Commercialization for Merck & Co., noted the variability in the discount on biosimilars compared with the originator, depending on the product, the country and how long the biosimilar has been on the market. He also stated that on average it cost $100–$200 million to develop a biosimilar drug.

Dr. Kozlowski stated that the FDA plans to issue general guidance on biosimilars by year end that will answer some industry questions about how to move forward with biosimilar development. Many of the panelists commented on how biosimilar approvals will make available to regulators new data about the originator drug that was not available when the originator was approved and thus could provide further insight into biotech development and manufacturing. Dr. Vanden Boom noted that the market for biosimilars is likely to push biotech companies to innovate rather than simply extend originator products.

Dr. Vanden Boom asked the Merck, Sandoz and Amgen executives on the panel about any tensions between their companies’ originator and biosimilar divisions. Drs. Windisch and Stout noted that there was tension at first, but that it has dissipated, and that the divisions collaborate technically both for development and manufacturing.

The conference’s exhibition featured over 120 companies, including several analytical technology providers. Agilent displayed its AssayMAP Bravo platform (see IBO 2/15/11), while Caliper Life Sciences showed its LabChip GX II system. Other instrument companies showcasing analytical technologies at their booths included Forte Bio, Gyros and Molecular Devices.

ProteinSimple introduced the Bot1 High Throughput Autosampler. It is designed for the MFI 5000 Micro-Flow Imaging platform, an imaging-based particle counter that measures shape, size, concentration and morphological parameters of particles 2–10 µm in size. The Bot1 enables higher-throughput monitoring of aggregation during formulation development. It holds up to 48 samples and provides automated sample introduction, washing and rising. The Bot1 will begin shipping in December.

Fogale Biotech exhibited the evo biomass probe and transmitter. The transmitter combines capacitance and optical density measurements of cell viability. For live cells, the capacitance sensor measures biomass concentration. For total cells, the optical density probe measures the medium turbidity of cell concentration.

Having applied its technology to a wide range of industries, MSP showed the FlowCytoPrep 5000, which is designed to make flow cytometry more amenable to use in biopharmaceutical manufacturing, for which the adoption has been hampered by the extensive sample preparation required, according to MSP. The FlowCytoPrep 5000 automates sampling, including washing, fixing, staining, dilution and injection. The latest version of the system features four stirred microreactors. Up to 16 parameters per sample can be measured. Sample interval time is typically between two and twenty minutes. Software modules allow for compatibility with flow cytotmers from multiple manufacturers. Other applications include food and biofuels.

The show was the North American debut of Sartorius’s CERTOMAT CTplus incubation shaker. Sartorius told IBO that the product is the first of its kind developed specifically for culturing mammalian cells. Features include a stainless steel interior and a sealed drive train to prevent corrosion. The maximum capacity is six 5L flasks.

Next year, the BioProcess International conference will return to Providence, Rhode Island. The 2012 conference will run October 8–12.