2016

Single-Use Technology Enables Flexible Factories

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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…

June 15, 2016

Ask the Expert Liposome and Viral Vector Characterization: Use of Electron Microscopy and Image Analysis

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with Dr. Josefina Nilsson For this webcast, Josefina Nilsson (EM Services business unit head) discussed Vironova’s work, including case studies. She focused on characterization of drug and gene delivery platforms with electron microscopy and image analysis, specifically for systems that use viral vectors or liposomes. Along with two colleagues — Gustaf Kylberg (image analysis expert) and Mathieu Colomb-Delsuc (electron microscopist) — she then answered questions from the audience. Nilsson’s Presentation Structural characterization provides important insights into the quality of development and…

June 15, 2016

Deciding on an Integrated Continuous Processing Approach: A Conference Report

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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…

June 15, 2016

May Supplement Spotlight

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World Vaccine Congress Names “Best CMO†At its annual meeting in Washington, DC, this past March, the World Vaccine Congress named Paragon Bioservices, Inc., as the “Best Contract Manufacturing Organization†(CMO) for 2016. The annual Vaccine Industry Excellence (ViE) Awards honor the industry’s most outstanding achievements in vaccine development around the world. This award is based on the service range in niche and core therapeutic areas, methods of performance improvement, attention to and quality of relationships with clients, reaching milestones…

May 17, 2016

May Supplement Introduction: The Evolving Outsourcing Culture

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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.…

May 17, 2016

From CMO to CDMO: Opportunities for Specializing and Innovation

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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…

May 17, 2016

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

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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…

May 17, 2016

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

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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…

May 17, 2016

Future Manufacturing Strategies for Biosimilars

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Biosimilars are a relatively new subset of biopharmaceuticals, with the biotechnology industry finally maturing such that off-patent generic-type products increasingly will be entering major markets (1–3). So far, more than 20 biosimilars for a limited number of reference products have been approved in major markets, primarily the European Union. Only two products have been formally approved as biosimilars in the United States. For this rapidly growing industry sector, little consensus or authoritative information is available yet regarding how and where…

May 17, 2016

Outsourcing Biosimilars Development

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A rapid increase in the number of companies working on development and registration of biosimilars has created a significant market for contract testing and manufacturing organizations (CTOs and CMOs) providing outsourced services specific to these products. Biosimilar developers turn to contract organizations when they lack either the internal capability or capacity for conducting certain work as well as when they require additional resources to bring products to market rapidly. A wide range of contract services are available, and each particular…

May 17, 2016