Cell Banking for Cell and Gene Therapy: Regulatory, Ethical, and Scientific...
Regenerative medicine holds great potential for human disease management, with hundreds of cell and gene therapy (CGT) products for tissue/organ reconstitution or replacement in different stages of...
View ArticleBioengineering for “Benchtop Clinical Trials”
Animal studies can be poor predictors of human drug response. Species-specificity of organs is a concern especially for the heart. Many drugs that enter clinical trials will fail ultimately because of...
View ArticleBioassay Evolution: Finding Best Practices for Biopharmaceutical Quality Systems
Bioassays help drug developers determine the biological activity (potency) of their products, which has been a biopharmaceutical critical quality attribute (CQA) since long before that concept had a...
View ArticleEvaluating Biosimilars: A View from the Small-Molecule World
For many years the pharmaceutical industry was dominated by small (usually synthetic) molecules, mixed with a number of nonactive materials and encapsulated or (in the really old days) rolled into...
View ArticleSupply and Demand Trends: Mammalian Biomanufacturing Industry Overview
Since the 1986 approval of the first recombinant therapeutic antibody, OKT3, biopharmaceuticals have become a large percentage of overall pharmaceutical company revenue. In 2018, sales of the top five...
View ArticleA Response Plan for Viral Contamination in Bioproduction Facilities
The biopharmaceutical industry uses living biological systems as a platform for manufacturing of protein-based drugs, vaccines, and other therapies derived from or consisting of different cell types....
View ArticleUsing Blockchain Technology to Ensure Data Integrity: Applying Hyperledger...
Digitalization of manufacturing operations is a major challenge that many industries face. With the advent of smart equipment, automation of unit operations and complete processes, and digitalization...
View ArticleThe Next Global Life-Science Leader
Canada’s life-science industry is exceptional at producing innovative research. With less than 0.5% of the world’s population, our country produces 5% of the globe’s total research publications....
View ArticleNew Directions in Bioprocess Development and Manufacturing
The biopharmaceutical industry continues to grow at a rapid pace. That growth is accelerating even more because of keen investor and research interests in cell and gene therapies. My focus below is on...
View ArticleDeveloping a Biopharmaceutical Workforce for Today and Tomorrow
Biomanufacturing is constantly evolving, developing new treatments and therapies through cutting-edge methodologies and facing increasing integration of big data and analytics. But keeping up with...
View ArticleBrazilian JBS Federally Inspected Fetal Bovine Serum
Serum is the most commonly used supplement in cell culture. Fetal bovine serum (FBS) is the common choice because it contains high concentrations of growth factors and other important signaling...
View ArticleA Framework for a Competency-Based Curriculum
Training departments in biopharmaceutical manufacturing facilities are at the forefront of ensuring that their employees are trained in accordance with regulatory compliance standards that govern the...
View ArticleDiscussions at Phacilitate 2020 on Business, Manufacturing, and Future Trends
Presenters in the three main program tracks at the Phacilitate Leaders World conference in Miami, FL, this past January represented sponsor-developers of cell/gene-therapy (CGT) products, contract...
View ArticlePatient Access Tops the List of Advanced Therapy Milestones at Phacilitate 2020
In a highly anticipated presentation at the 2020 Phacilitate Leaders World event — part of Advanced Therapies Week, along with the World Stem Cell Summit in Miami, FL — Susan Nichols (chief executive...
View ArticleA Healthy Biosimilars Market Promotes Innovation and Affordability
Innovative drug manufacturers require an opportunity to recoup capital and opportunity costs that they incurred to develop new medicines. Once patents have expired, competitors should be empowered to...
View ArticleCell and Gene Therapies Get a Reality Check: A Conversation with Anthony...
As founder of cell and gene therapy (CGT) specialist firm Dark Horse Consulting Group in California, Anthony Davies speaks from a quarter century of experience including former positions at Onyx...
View ArticleVirtual Audits: A New Reality in the World of COVID-19
The novel coronavirus disease 2019 (COVID-19) pandemic has every industry seeking out ways to accomplish time-sensitive activities using a number of virtual approaches. This is certainly true in the...
View ArticleBiosimilars 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...
View ArticleLife-Science Lawsuits: Learning from the Ordeal
Life-science companies often are cast into the role of the “canary in the coal mine” — the first parties to be targeted and hit by lawsuits. Such companies depend on discovery, trial and error, and...
View ArticleFinding Efficiencies to Accelerate Biopharmaceutical Development
An old engineering adage says that in any technical project, you can get speed and/or quality and/or cost-efficiency — but you never get to have all three. The idea is that emphasizing any one of those...
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