In this audiocast, BPI’s managing editor Maribel Rios talked with Karol Lacki (staff scientist at GE Healthcare Biosciences) about the use and future of protein A in bioprocessing. Its selectivity, robustness, and well-known ability to bind to a wide range of IgG molecules have made protein A a widely accepted affinity resin for current purification streams. Nonetheless, the industry has raised some concerns over cost, productivity, and other issues. That has led to the development of novel alternatives for purification…
Tuesday, October 1, 2013 Daily Archives
Virological Safety of Biopharmaceuticals
In an audiocast with managing editor Maribel Rios, Hazel Aranha (manager of viral clearance and safety at Catalent Pharma Solutions) discusses risk assessment and management strategies since her November 2005 article, “Virological Safety of Biopharmaceuticals.†Several factors have made risk an increasingly important issue, including the globalization of the industry and concerns over emerging viruses. Some strategies for addressing risk — such as the “as low as is reasonably practicable†(ALARP) approach and conducting a cost–benefit and decision analysis —…
Gallus Strengthens Biologics CMO Business with Acquisition of Laureate
Gallus BioPharmaceuticals, LLC Gallus Strengthens Biologics CMO Business with Acquisition of Laureate (St. Louis, Missouri – October 1, 2013) – Gallus BioPharmaceuticals, LLC (Gallus), a leading biologics contract manufacturing organization (CMO), today announced its acquisition of Laureate Biopharmaceutical Services, Inc. (Laureate), a full service biologics CMO located in Princeton, New Jersey. This acquisition doubles Gallus’ process development (PD) and clinical drug substance manufacturing capacity, adds full protein characterization, testing and clinical fill-finish capability and offers a seamless development pathway for…
Biomedical Advanced Research and Development Authority (BARDA) Exercises Option with Pfenex Inc. To Extend Contract and Increase Funding for the Development of a Recombinant Protective Antigen (rPA) Based Anthrax Vaccine
Pfenex Inc. Biomedical Advanced Research and Development Authority (BARDA) Exercises Option with Pfenex Inc. To Extend Contract and Increase Funding for the Development of a Recombinant Protective Antigen (rPA) Based Anthrax Vaccine Funding will be provided by the Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services. San Diego, CA, October 1, 2013 – Pfenex Inc. today announced that the Department of…
Anticipating Success: Meeting the Inherent Challenges of Complex Drug Substances
Realizing the full potential of a novel injectable drug compound is no small task. In the months and years that lead from the exciting discovery phase to the rigorous demands of a commercial launch, unexpected scientific and technical challenges can slow development to a halt, often at key stages. A careful, systematic approach to identifying where and why these roadblocks can occur is fundamental to staying on course. Just as important is a robust, repeatable process design focused on retaining…
Designing Quality into the Product: Early Developability Assessment in Biopharmaceutical Development
The ultimate objective in the development of any new therapeutic candidate is the validation of its mechanism of action and therapeutic efficacy in a clinical setting. Three important areas of product development critical to determining the success of a new drug candidate are: manufacturing, safety, and delivery of the product to patients. Early attrition observed during preclinical stages can often extend development timelines or require additional process optimization, therefore costing the developer more time and money. It is desirable to…
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…
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),…
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…
Spray-Dry Manufacture of Vaccine Formulations
Development of vaccines and immunotherapeutics has expanded rapidly due to technological advances in the fields of molecular biology and bioprocess engineering, as well as a smoothing of management and material logistics worldwide. Expression platforms and novel cell lines have enabled creation of increasingly complex vaccines. The advancement of vaccine formulation development is also capitalizing on new advances in manufacturing that use model-based methodologies gleaned from physiochemical principles, process analytical tools, and systematic approaches to problem solving. Herein we highlight recent…