Manufacturing

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…

May Supplement Introduction: The Evolving Outsourcing Culture

When I began recruiting contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) to join the Pharma & Biopharma Outsourcing Association two years ago, some of the biologics-focused companies were concerned about being in a trade association alongside small-molecule–focused providers. It wasn’t quite “Upstairs, Downstairs,” much less a Sharks vs. Jets rivalry, but they weren’t sure whether my big-tent approach was viable. (For you millennials in the audience, please replace those references with “Downton Abbey” and “Batman v.…

From CMO to CDMO: Opportunities for Specializing and Innovation

Biopharmaceutical contract manufacturing organizations (CMOs) were initially enabled when the requirement for a company to file for both an establishment license application and a product licensing application transitioned to the current format of a biologics license application (BLA) submission for biological products (1). The initial focus of such CMOs was to provide large-scale, commercial manufacturing for companies that had already developed and validated bio manufacturing processes. Consequently, CMOs were generally formed as stand-alone service providers that “rented” manufacturing capacity to…

Best Practices for Technology Transfers Across a Global Network: A Discussion with Patheon’s Paul Jorjorian

A strategic technology transfer plan is the touchstone of global biomanufacturing enterprise, especially for contract service providers that must meet the needs of customers located across several continents. Like their clients, contract development and manufacturing organizations (CDMOs) are facing shortened timelines and cost pressures. They are turning to their process engineers and technology transfer teams to ensure communication with sponsor companies and streamline the transfer of information and critical activities between process development (PD) and manufacturing. In his presentation at…

Outsourcing to Enhance Assurance of Supply: Application of Counterintuitive Supply Chain Strategies — A Case Study

Single-use technologies have transformed biopharmaceutical manufacturing by providing tremendous and proven opportunities to reduce costs, improve flexibility, and shorten cycle times. The expansion of such technologies into commercial production has naturally raised new challenges for both end users and suppliers, thus driving the need for a critical look at risks associated with their use. End users now face a new challenge: how to assess their own supply chains for robust assurance of supply. What is the suppliers’ responsibility in addressing…