Leachables/Extractables/Particulates

Compatibility Assessment of a Model Monoclonal Antibody Formulation in Glass and Blow–Fill–Seal Plastic Vials

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PREPRINT October 2015 issue Blow–fill–seal (BFS) technology has been recognized by the industry as an advanced aseptic solution (1–3). Catalent Pharma Solutions has been commercially supplying sterile BFS products to the pharmaceutical industry for decades, primarily in the respiratory and topical ophthalmic markets. Such product formulations range from simple solutions to emulsions with drug substances from classical small molecules to large complex proteins such as biologics. The company also has optimized BFS processes and its Advasept plastic container system for…

July 13, 2015

Toward Industry Standardization of Extractables Testing for Single-Use Systems: A Collective BPSA Perspective

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Here we present a consensus position of the membership of the Bio-Process Systems Alliance (BPSA), the trade organization for the single-use industry based in Washington, DC. BPSA’s membership includes 48 corporate and institutional entities, among them component suppliers, systems integrators, end users, and independent testing laboratories. Consensus within this membership is reached through an official ballot of representative voting members, as provided for in the organization’s by-laws. The position outlined below was approved by such an internal consensus-balloting process. Building…

March 10, 2015

Extractables Profiles: A Comprehensive Approach Produces Long-Term Results

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Biopharmaceutical manufacturers spend years developing and testing new drug and biologic products to ensure their efficacy, safety, and usability for patients. Such knowledge is extremely valuable, but those same principles often get overlooked in selection of packaging and delivery systems. Decisions on packaging and delivery often are made almost as an afterthought. However, issues related to components such as extractables and leachables can affect patient safety and product quality. In addition, a lack of extractables and leachables data in filings…

March 10, 2015

Simulating Seal Life with Finite-Element Analysis

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Finite-element modeling is an attractive alternative to physical testing for predicting seal life, particularly when aging poses major concerns and seal replacement is expensive. For years, seal manufacturers and users alike have searched for a reliable method for predicting how long seals will last in service. Past methods for evaluating an elastomer’s potential as a static or dynamic seal use American Society for Testing and Materials (ASTM) or other standard immersion tests. These tests involve submerging a material in a…

February 6, 2015

Evaluating Freeze–Thaw Processes in Biopharmaceutical Development – Small-Scale Study Designs

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Regulations mandate that biopharmaceutical product quality be controlled throughout manufacturing, storage, transportation, and delivery to patients (1). Operations often include freezing and thawing of a bulk drug substance, dilution of that purified substance to a target concentration, filtration, filling into a selected container–closure system, additional processing (e.g., lyophilization), inspection, packaging, storage, transport, and delivery (2). Freezing is a common processing step used to maintain stability and quality of a drug substance during development and production of biopharmaceutical products. It is…

January 13, 2015

Trends in Setting Single-Use Technology Standards

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The biopharmaceutical industry now incorporates single-use (SU) technology and systems in most production processes based on cell culture (1, 2). Implementation of such technologies has led to the availability of prepackaged and sterilized systems complete and ready for use with preinstalled mixers and monitoring probes. From upstream process- material preparation through final-product formulation, biopharmaceutical sponsors are increasingly presented with numerous SU solutions that support all major production platforms (3–5). The number of SU materials and suppliers in biopharmaceutical manufacturing has…

October 16, 2014

Inactivated Poliovirus Vaccine Made in Modular Facilities with Single-Use Technology

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If current efforts to eradicate polioviruses worldwide are successful, then the oral poliovirus vaccine (OPV) currently used for routine immunization in low- and middle-income countries (LMICs) will be replaced by inactivated poliovirus vaccine (IPV). IPV will become the only option for such countries if they want to continue to vaccinate against polio (1). Because IPV is currently considered to be too expensive for use in LMICs, strategies are being undertaken to make IPV more affordable (2). Some experts estimate that…

October 1, 2013

Simpler and More Efficient Viral Vaccine Manufacturing

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Human and veterinary vaccines are divided into five main categories: conjugate, toxoid, subunit, inactivated (killed), and live (attenuated) vaccines (1). The vast majority of currently licensed human and veterinary vaccines are inactivated or live (2, 3). They are produced mostly using adherent cells: primary cells such as chicken embryo fibroblasts (CEF), human diploid cells such as MRC-5, or continuous cell lines such as Vero and MDCK (4). The pioneering legacy inherited by vaccine manufacturing development has led to strategies for…

October 1, 2013

Drug Products for Biological Medicines

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The California Separation Science Society (CASSS) held a Chemistry, Manufacturing, and Controls (CMC) Strategy Forum on drug products for biological medicines in July 2012 in Bethesda, MD. Topics included novel delivery devices, challenging formulations, and combination products. This CMC Strategy Forum aimed to promote an understanding of how best to increase the speed and effectiveness of drug product and device development for both large and small companies. Participants focused on areas that improve the likelihood for regulatory success, reduce risk,…

June 1, 2013

Broadening the Baseline

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When the editors of BPI asked us at BPSA to put together a content-rich article on single-use issues, we were happy to do so. Our challenge was how to bring in multiple viewpoints about the growing business of single-use that would be a “quick read” for the BPI audience. The answer: an expert colloquy. Represented here are several of the most qualified industry spokespersons in single-use — all are members of BPSA and speak as directors of the alliance. Their…

May 1, 2013