Analytical

Enhancing Efficiency and Economics in Process Development and Quality Control of Biotherapeutics

by

Analytical techniques that measure protein quantity and quality are used in nearly all stages of research, process development, quality control and manufacturing of biotherapeutics. UV spectroscopy, ELISA and HPLC have been in use for decades for protein quantitation in physiological and process samples, and continue to be the workhorses despite their many limitations. Biopharmaceutical companies have enthusiastically adopted Pall ForteBio’s Octet® systems due to their high throughput capabilities, decreased sample preparation requirements, and low cost of operations. The Octet systems…

October 24, 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

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

New Paradigms for Process Validation

by , , , , , , , , , , , and

    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…

October 1, 2013

Cellular Communications

by

Like spectroscopy, as discussed in BPI Lab last month (1), cell signaling is not a laboratory technique but rather an area of scientific study. The environment of living cells — whether prokaryotic or eukaryotic, in vitro or in vivo — comprises not only water, nutrients, waste products, and metabolites, but also molecules released by other cells in response to intracellular events such as microbial infection and disease state or environmental factors such as temperature, osmolality, and pH. Receptor proteins on…

October 1, 2013

Development of Protein Capsular Matrix Vaccine Platform Technology

by , , and

Polysaccharide vaccines account for about 30% of the total >$20-billion/year vaccine market. Despite efficacious vaccines in the field, diseases such as invasive Streptococcus pneumoniae and typhoid fever persist. Development of multivalent polysaccharide conjugate vaccines requires complex chemistries and multiple, expensive good manufacturing practice (GMP) process steps. Matrivax Research and Development Corporation is developing a protein capsular matrix vaccine (PCMV) technology that simplifies synthesis of polysaccharide vaccines with fewer process steps than are required by typical conjugation vaccine processes. Polysaccharide Vaccine…

October 1, 2013

Emerging Challenges to Protein A

by

Protein A affinity chromatography has been a target for replacement since its commercial debut, mainly because of its high acquisition cost. The technique became established despite the cost because it was born into an industrial culture that favored speed to market over manufacturing economy (1). Vendors have since strengthened protein A’s position with incremental but worthy improvements such as higher capacity, lower ligand leaching, and modest tolerance of NaOH. Collateral improvements in polishing technologies, such as the high throughput and…

October 1, 2013

An Industry–Academia Partnership

by and

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…

October 1, 2013

Container–Closure Integrity

by , , and

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),…

October 1, 2013

Enlightening Results

by

Separating spectroscopy from spectrometry is not as straightforward as it might seem. Spectroscopy is the science of the interactions between matter and radiated energy, and spectrometry is the technology that applies that science (1). The former generates no results on its own. It is concerned with spectra produced when matter interacts with or emits electromagnetic radiation, including all methods of producing and analyzing light spectra using spectroscopes, spectrographs, spectrometers, and spectrophotometers. The distinction should come from the meanings of the…

September 1, 2013