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How BARDA locked up COVID-19 vaccine manufacturing capacity for Operation Warp Speed

The government agency that develops medical countermeasures for the US stockpile says it had to move quickly to secure contract manufacturing plant capacity for COVID-19 vaccines before the private sector could “capture” it. There was no time to give other contract manufacturers a chance to bid for the work, which the Health and Human Services Department’s Biomedical Advanced Research and Development Authority, or BARDA, recently awarded in a pair of task orders totaling nearly $900 million. BARDA awarded a $628…

The Role of New Technology in Enabling Cell and Gene Therapies

Moderator Doug Miller, with Tim Kelly, Daniella Kranjac, Andy Ramelmeier, and Ran Zheng This part of the BPI Theater program focused on emerging bioprocess technologies and their implications for cell and gene therapy (CGT) products. Doug Miller assembled a panel showcasing a wide range of technical expertise and representing several CGT industry stakeholders. That pluralism yielded far-reaching discussions about what CGT capabilities exist, what advances could facilitate therapy manufacture, and how companies might pursue technological development. Viral-Vector Therapies Miller kicked…

Early Stage Analytical Considerations for Late Stage Biologics Success

This BPI Special Report will cover phase appropriate analytical strategies that will balance various drivers to meet overall development goals without sacrificing the requirements of a program. The goal is to provide important recommendations for analytical method development that can help the biopharmaceutical industry identify opportunities to improve lead time and reduce development costs while maintaining required quality standards. Fill out the form below to learn more about analytical method development now.   Arugadoss Devakumar, PhD, is director of analytical…

Biosimilars Pipeline and Market Trends

Most biopharmaceutical industry experts now consider biosimilars to be mainstream products, indicating that the field has progressed immensely over the past 10 years. Nevertheless, when comparing approvals and commercial offerings across the globe between 2013 and 2020, it becomes clear that some regions welcome these therapies more than others do. Western European biosimilars markets continue to be kind to these drugs’ production, distribution, and coverage; and companies headquartered in Asia and the Pacific Rim increasingly are getting involved in biosimilars…

Managing Risk in Single-Use Systems Design and Implementation: A Shared Responsibility

Managing risk in single-use systems design and implementation is a shared responsibility. The ultimate responsibility for drug processes and products will always remain with manufacturers. However, implementation of single-use systems can shift responsibilities to suppliers within key areas, including design and sterilization, which must be clearly controlled and validated. This Special Report discusses how suppliers and manufacturers when working together can mitigate the risk of applying single-use systems in biopharmaceutical production from design through validation to point-of-use testing and operator…

Fighting Alzheimer’s Disease with a Breakthrough Peptide

Even more so than cancer, Alzheimer’s disease is one disease that many people fear greatly. The thought of falling prey to the inevitable desecration of our own minds is something that makes even the bravest among us shudder. If we’re robbed of our sense of who we really are, we imagine, then we are doomed to live our last days without the dignity that defines us and that we hold most dear. The ultimate horror of the condition is that…

BVDV Risk Mitigation: Dealing with Bovine Viral Diarrhea Virus in Serum

Bovine serum products such as fetal bovine serum (FBS) are critical, nutrient-rich supplements frequently used in cell culture systems for a number of applications, including biotechnology, animal and human pharmaceutical and diagnostic manufacturing, and life-science research. Serum can be contaminated with adventitious agents that could increase its risk for use in cell culture systems. Bovine viral diarrhea virus (BVDV) is one of the most significant infectious diseases in the livestock industry worldwide because of its high prevalence, strong persistence, and…

Commercialization Frameworks for the Biopharma Ecosystem

Kiran Chin, managing partner and CEO, MKA Insights Chin began her presentation by introducing her company and its focus on helping bioprocess, life sciences, clinical diagnostics, and gene therapy companies accelerate growth. Although there is no shortage of information on data processes, Chin has found that many companies lack focus on some fundamentals that drive commercialization strategies. Companies tend to dive in without asking basic questions: Why do we exist? What are our capabilities? What is the technology that we…