2013

An Industry–Academia Partnership

GE Healthcare Life Sciences recently launched a joint program with Osaka University to support future growth of the biopharmaceutical sector in Japan. Together, they offer students access to GE Healthcare’s expertise in training and technologies for bioprocess research and manufacturing. The program is funded by Osaka University as part of its “Interdisciplinary Program for Biomedical Sciences” (IPBS), a government-funded commitment to graduate education. The goal of IPBS is to educate young scientists to undertake global-scale collaborations to develop effective treatments…

Container–Closure Integrity

An increasing number of biopharmaceuticals — including vaccines, stem cells, and proteins — require cold storage to maintain efficacy before use. However, the ability to maintain container–closure integrity (CCI) during cold storage is not completely understood. Concerns about CCI failure have been raised for storage and shipment of such products in rubber-stoppered vials under cold conditions (e.g., −80 °C or on dry ice). Commonly used butyl stoppers are believed to lose their elastic properties below their glass transition temperature (Tg),…

From the Editor

      With the approaching holiday season and the end of the year — how can that be? — we find ourselves pretty well settled into plans for our 2014 editorial calendar. As a team, we’ve met during the summer to brainstorm and share the results of our research into the subjects of next year’s special reports and supplements. What should we focus on next? What old themes and supplement topics need to be revisited, and what new topics…

Virus Risk Mitigation for Raw Materials

Recombinant protein–based medicinal products and modern cell-based vaccines have a very strong safety history with respect to viral and microbial contamination. However, virus contamination incidents do occur occasionally in manufacturing processes, and they can consume many resources and be expensive to rectify. The root cause of contamination incidents in recent years is most likely the use of contaminated raw materials. These include bovine serum contaminated with reovirus, epizootic hemorrhagic disease virus, Cache valley virus or vesivirus 2117; porcine trypsin contaminated…

Development Strategies for Novel Vaccines for Infectious Diseases

In a vaccine development program, the probability of success at each transition decreases, even though the actual probability of moving from one phase to another can be 50–80% (Figure 1). Many compounds and vaccine candidates are screened out even before they get into preclinical studies. Developers can implement different approaches to reduce product failure risk before a program gets expensive, including Establishing a product development plan (PDP) Identifying and mitigating risk with gap analysis Learning from the mistakes of others…

Industry Adoption of Membrane Adsorbers

Membrane adsorbers (MAs) are the fastest-growing segment in single-use bioprocessing. But their future is not entirely certain. According to BioPlan Associates’ latest survey of biopharmaceutical manufacturing, the MA market has been growing at ~20% annually since 2006 (1). Paradoxically, however, the segment may not be a true “rising star.” Our study also shows that MAs remain among the least-often adopted devices among biomanufacturers. So the question of how and whether MA technology can revolutionize bioprocessing remains open. Market for Membrane…

Simpler and More Efficient Viral Vaccine Manufacturing

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…

A CMO Perspective on Quality Challenges for Biopharmaceuticals

    The global annual revenue for biopharmaceuticals has been growing consistently since 2001, accounting for 15.6% of the total pharmaceutical market in 2011. The global biopharmaceutical market was valued at US$138 billion in 2011 and is expected to surpass $320 billion by 2020 (1). The market for recombinant proteins now exceeds $100 billion, a milestone attained in 2011. Figure 1:  ()   Much of the growth in biopharmaceutical revenue is due to an increasing number and sales of recombinant…

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

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…

New Paradigms for Process Validation

    Both the United States and the European Union have recently evolved guidance on how to execute process validation (1, 2) with the prospect of a more appropriate life-cycle approach. It goes beyond the traditional three to five lots run at the center point of proposed ranges for operating parameters. New approaches leverage product design and process development information. They facilitate adapting the quality by design (QbD) paradigm to allow for a science- and risk-based selection of critical process…