A Look Ahead in Biomanufacturing

From time to time, it's important to take stock of the industry from both a retrospective and prospective point of view. Throughout 2012, we celebrated 25 years of BioPharm International, looking back at major advancements in technology, biologics development and processing approaches, and regulatory science. As we enter 2013, we are eager to envision what the future of biopharmaceutical manufacturing will bring. We've asked our editorial advisory board members to provide their perspective on what's ahead. Below are a few highlights.

Angie Drakulich

"As biopharm molecules continue to grow relative to small molecules, classical pharma companies will invest and acquire more biopharm companies. The number of new drug targets is growing slowly, so firms are focusing on specific clinical areas. Monoclonal antibodies (mAbs) and mAb-similars will continue to be the biggest molecule segment because it offers a flexible drug platform. We will see improvements in ease-of-use and cost, such as smaller volume dosage and less frequent administration. Biosimilars will emerge over the next 10 years, driven by customer cost pressures and the reduced development risk for manufacturers. Improvements in disposables (e.g., integrity, extractables) will drive further adoption to reduce classified air and water utilities and speed process turnaround." —Herb Lutz, EMD Millipore

"As technologies continue to improve, 'fit-for-purpose' manufacturing will become even more prevalent. Large, single-product manufacturing factories will be replaced by smaller, more modular, multiproduct facilities using disposable equipment. Companies will use an ever-growing network of CMOs. Moreover, these facilities will increasingly be located within the country/region whose population is served by life-changing medicines." —Denny Kraichely, Johnson & Johnson Pharmaceutical R&D

"Despite the continued growth of biopharmaceutical products worldwide, their high cost and foreign manufacture make them expensive and difficult to obtain in many emerging markets. These countries want to provide top-tier medical care to citizens but struggle to pay for expensive therapies. To meet these challenges, the manufacture of biopharmaceutical products will require local stateoftheart facilities designed on standard platform processes, built using advanced modular design and construction, and incorporating single-use technologies wherever possible." —Howard L. Levine, BioProcess Technology Consultants

"Uniform product quality is a key issue as manufacturing expands globally. Regulatory oversight should prevent entry of low quality material into distribution chains. The solution will be a global regulatory force to match the global industry. Early forms may be found among the International Conference on Harmonization, the Global Harmonization Task Force, and the Pharmaceutical Inspection Co-operation Scheme. The problem will be to create a system where quality standards have the legal status to prevent distribution of substandard products within cooperating countries." —Steven S. Kuwahara, GXP BioTechnology

"Pharmaceuticals, biologicals, biosimilars, and vaccines will increasingly be produced in Asia by low-cost suppliers, provided they can follow globally harmonized GMP standards. Much of this work will use single-use technologies where scale is appropriate, based on capital cost savings, enhanced containment, elimination of cleaning concerns, and reduced water requirements. Vaccines will be produced locally in emerging markets, also using single-use technologies. Concerns over counterfeiting and other supply-chain risks may generate the return of jobs to the US pharmaceutical industry, provided that wages can be competitive." —Jerold Martin, Pall Life Sciences

"The limit between large and small molecules will become blurred. Small molecules will become more functionally complex, while large molecules will be trimmed to their essential functions for easier application. Fragment antibodies, conjugates, targeted glycoforms and oligosaccharides, 3D matrices, large-scale stem-cell production, and others will need new and affordable production approaches, which one day may include cell-free production or plant-based biofactories. All this is likely, while one old challenge remains: the downstream bottleneck." —Hans-Peter Meyer, Lonza AG