Leachables/Extractables/Particulates

Simulating Seal Life with Finite-Element Analysis

by

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

by , , and

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

by and

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

by and

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

by

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

by

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

by , and

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

Single-Use Technology and Modular Construction

by , , , , , and

To enable broad, global access to life-saving biopharmaceutical products, our industry is facing significant pressure to reduce the overall cost of manufacturing and enable local manufacturing where possible. Combined with growing markets outside the United States and Europe and development of high-titer, high-yield processes, that pressure has led to a shift in the industry’s approach to facility design and construction. Today’s biopharmaceutical production facilities must be flexible, cost effective, and readily constructed with minimal capital investment and construction timelines. As…

April 1, 2013

Broadening the Baseline

by , and

When the editors of BPI asked us at BPSA to put together a content-rich article for the single-use supplement, 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 (a “conversational exchange or topical dialogue”). Represented here are several of the most qualified industry spokespersons in single-use — all are members of BPSA and…

April 1, 2013

Single-Use Pumps Take Center Stage

by and

The multibillion-dollar global biopharmaceutical industry is placing increased emphasis on development and manufacture of advanced biologics. Such products offer exciting potential for the development of drugs that could provide as-yet-unknown treatments for a wide array of diseases. One important goal is to commercialize biologic products as early as possible within the typical 20-year patent window. Patent submission must occur during drug development. Much work follows a patent filing, including further product development, toxicity checks, and clinical trials. Hopefully, US Food…

April 1, 2013