Manufacturing

Outsourcing Trends in Biosimilars Development: A Discussion with Niall Dinwoodie (Charles River Laboratories)

No discussion about the future of the biopharmaceutical industry would be complete without assessing the impact of biosimilars. But such discussions no longer focus on whether biosimilars will enter the market, but rather when and how much market share will they take. The rapid progression of biosimilar candidates in company pipelines and the strong biosimilars research conducted by international organizations are strong indications that if your company is not already working within the biosimilars market, it may already be too…

Making the Correct Outsourcing Decisions: BPI Theater Panelists at BIO 2016 Discuss Current and Future Needs for Contract Services

Outsourcing has become a critical part of the industry in general and will play a larger role as companies continue to seek faster and more cost-effective routes to market. On Wednesday 8 June 2016, Gil Roth (president of the Pharma and Biopharma Outsourcing Association, PBOA) chaired a lunchtime roundtable titled “Making the Correct Outsourcing Decisions.” Roth’s association is a nonprofit trade group that represents CMOs and CDMOs through work with Congress and the FDA, with a focus on intra-industry issues.…

Harnessing the Power of Big Data to Improve Drug R&D

Like many other industries, biotechnology is being transformed by the emergence of big data — extremely large data sets that can be analyzed to reveal patterns, trends, and associations — and advanced analytics. Information from multiple sources such as electronic health records, payer claims, and mobile health platforms is growing exponentially. When used and harnessed properly, these data can boost the efficiency of drug research and development (R&D) in three critical areas: early R&D investment, drug development, and personalized medicine.…

Moving Toward a Continuous Future

During the March 2016 BPI West conference in Oakland, CA, BPI publisher Brian Caine and I had an opportunity to meet with Michael Egholm, PhD, Vice President and General manager of Biopharmaceuticals at Pall Life Sciences. We are pleased to be able to share his thoughts about Pall’s support of continuous processing — and the company’s current offerings. Montgomery: Not everyone seems to be defining continuous processing in the same way. What is your general concept of it? Egholm: At…

Center of Excellence

Enabling Continuous Processing Using a Step-by-Step Approach

Mario Philips is Vice President and General Manager of Single-Use Technologies at Pall Life Sciences. In February, he spoke with BPI publisher Brian Caine and editor in chief Anne Montgomery about Pall’s commitment to enabling continuous processing and its development of single-use technologies. In that discussion, he addressed some major process bottlenecks and Pall’s solution to them, including centrifuge replacements by continuous acoustic wave separation, continuous chromatography with multicolumn chromatography technology platform, and a simplified version of tangential-flow filtration. Read…

Bacteriophages, an Alternative to Antibiotics: Challenges and Possible Solutions for Bringing Them to Market

Bacteriophages are viruses (consisting of a genome contained within a protein coat) that specifically infect bacteria. They are the most abundant living entities on earth — the estimates range from 1030 to 1032 in total — and play key roles in regulating the microbial balance in every ecosystem where that has been explored (1). Bacteriophages are genotypic and phenotypically different from viruses that infect Archaea (Archaeovirus) and Eukarya (Eukaryovirus). The name bacteriovirus has been proposed as scientifically more accurate (2).…

Bridging Polymer Science and Biotechnology Applications with Single-Use Technologies

Implementation of single-use technology in the biotechnology industry is increasing every year. One major interest has been understanding the interaction of extractables with protein and cells for applications ranging from cell banking to biopharmaceutical manufacturing. In October 2015, the Engineering Conference International (ECI) organization hosted a conference in Leesburg, VA, to explore how the science of plastic applies to bioprocessing. The “Single-Use Technologies: Bridging Polymer Science to Biotechnology Applications” meeting brought together experts from different fields to share issues, understanding,…

A Single-Use, Clinical-Scale Filling System: From Design to Delivery

Single-use components have been successfully incorporated into many unit operations for both upstream and downstream processing, from laboratory scale to commercial manufacturing. The development of single-use filling needles has created an opportunity to introduce fully disposable systems into final formulation and filling of drug products (1). One major challenge in replacing a cleanable filling line containing stainless steel needles is to ensure that an alternative system can satisfy all critical performance parameters established for an existing process. In 2012, Merck…

Single-Use Technology Enables Flexible Factories

The biosimilars market is rapidly evolving, with more than 450 biosimilar molecules in development worldwide, and many anticipated transfers of molecules in process around the globe. With US$85 billion of biopharmaceutical products coming off patent by 2020 (1), the driving force to develop biosimilars is strong. The market will be highly saturated, with dozens of biosimilars currently in development for each current blockbuster molecule. We know of 46 trastuzumab biosimilars and 39 rituximab biosimilars in development. Because the biosimilars market…

Deciding on an Integrated Continuous Processing Approach: A Conference Report

Biopharmaceutical manufacturers are increasingly investigating or implementing continuous processes, and industry experts are participating in vibrant and healthy discussions on a wide range of process approaches being adopted. We seem to have entered a phase within the biopharmaceutical industry (which is often described as conservative) of intense bioprocess innovation as manufacturers strive to lower costs and provide agile, responsive supply chains for “drug on demand” continuous manufacturing operations. Senior industry leaders met in Berkeley, CA, in late 2015 at ECI’s…