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…
2013
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),…
October 2013 Issue Author Insights
Standards for Ancillary Materials Used in Cell- and Tissue-Based Therapies
Cell- and tissue-based therapies are being used increasingly to treat many diseases for which currently no other adequate treatment options are available. These products contain human or animal cells that can replace, regenerate, or augment a recipient’s diseased, dysfunctional, or injured cells, tissues, or organs. Cells or tissues might be unmanipulated, or their biological characteristics can be altered ex vivo before administration of the final product to patients. Examples of cell therapies range from traditional blood transfusions to recent approaches…
Upstream Processing
The “Cell Culture and Upstream Processing” track began many years ago as a conference of its own. In October 2004, IBC Life Sciences brought it together in Boston, MA, with three other events (“Recovery and Purification,” “Production and Economics,” and “Scaling Up from Bench to Clinic”) to create the first BPI Conference. Just like BPI magazine’s editors, the event producers have depended on industry advisors from the beginning. Our editorial advisory board (EAB) members give generously of their time and…
Enlightening Results
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…
Downstream Processing
The “Recovery and Purification” track began many years ago as a conference of its own. In October 2004, IBC Life Sciences brought it together in Boston, MA, with three other events (“Cell Culture and Upstream Processing,” “Production and Economics,” and “Scaling Up from Bench to Clinic”) to create the program of the first BPI Conference and Exhibition. Just like BPI magazine’s editors, the event producers have depended on industry advisors since the beginning. Our editorial advisory board (EAB) members give…
Protein A
The number of blockbuster monoclonal antibody (MAb) drugs continues to grow. In 2008, MAbs generated revenues in excess of US$15 billion (1), making them the highest-earning category of all biotherapeutics. The world MAb market will reach $62.3 billion in 2015, with next-generation therapeutic antibody revenues reaching $2.3 billion in 2015 according to Visiongain reports published in September and November 2011 (2, 3). Biosimilar antibodies will also begin to enter established markets as regulatory authorities clear approval pathways for them. Most…
Manufacturing
We editors think of the “manufacturing” theme as a sort of catch-all category for technical issues that aren’t specifically protein-production or separation/purification related. For us, that has always included assay development and other analytical topics that are more product- than process-focused. For the purposes of this conference-guide supplement, however, we have developed a separate article for analytical matters. So what falls under manufacturing? In past BPI Conferences, tracks such as “Production and Economics” and “Scaling Up from Bench to Clinic”…
NIR Spectroscopy for Process Monitoring and Control in Mammalian Cell Cultivation
The quality by design (QbD) and process analytical technology (PAT) approaches have shown significant benefit in the classical pharmaceutical industry and are now strongly influencing bioprocessing. Monitoring critical process parameters (CPPs) during biotechnological cell cultivations is essential to maintaining high efficiencies and quality. Commercial sensor systems for real-time inline monitoring are available for some parameters, such as pH or the concentration of dissolved oxygen (DO). For others such as glucose concentration, total cell count (TCC), and viability no robust online…