This podcast features: Russell Madsen In this interview with BPI Managing Editor, Mirabel Rios, author Russell Madsen, President of the Williamsburg Group, LLC, provides an update to his two-part article that first appeared in April and May of 2010.
Podcasts
Novel Excipients Prevent Aggregation in Manufacturing and Formulation of Protein and Peptide Therapeutics
This podcast features: Ed Maggio
Recommendations for Extractables and Leachables Testing
This podcast features: Raymond Colton
January 2014 Issue Author Insights
Establishing a Research Agenda in Bioproduction
In an audiocast with managing editor Maribel Rios, Rick Johnston (principal at Bioproduction Group), discusses his views on some changes in the biomanufacturing industry since his January 2008 article, “Establishing a Research Agenda in Bioproduction.†In that article, Johnston reviewed some of the industry’s operational challenges, including the need for supply chain reliability, uncertainty in demand and production processes, and variability in quality assurance and quality control. In the audiocast, he talks about steps the industry has taken toward addressing…
Reviewing Bioindustry’s Economic Year in 2013
This month, managing editor Maribel Rios discusses the financial state of the bioindustry with Howard Levine, founder, president, and principal consultant of BioProcess Technology Consultants. The industry is facing new opportunities for sales growth not only in the United States and Europe, but also in emerging markets such as those in Brazil, Russia, India, and China (the “BRIC†nations). Some of that growth comes from an increasing pipeline of biosimilars driven by the patent expiration of some major blockbuster biotherapies.…
Successful Sterilization Using Chlorine Dioxide Gas
In an audiocast with managing editor Maribel Rios, an author looks back on his report of a unique cleaning method from BPI’s first year over a decade ago. Amnon Eylath (senior director of quality assurance at Genzyme, formerly of Amgen) discusses the two-part 2003 article, “Successful Sterilization Using Chlorine Dioxide Gas.†(Read Part 1 or Part 2 ) That article described Amgen’s development of a process for disinfecting the surfaces of an isolator and process vessels using chlorine dioxide (CD)…
Analytical Advances: The Power of Mass Spectrometry
This month, Lester Taylor, director of LC-MS product marketing, and Ning Tang, senior application scientist (both at Agilent Technologies) talk about the advances that have extended adoption of mass spectrometry (MS) in QA/QC laboratories. Ideal technologies for analyzing large proteins and peptides include high-resolution LC-MS time-of-flight (TOF) spectrometry and hybrid LC-MS quadrupole TOF (Q-TOF) methods. The experts also discuss software tools for MS analysis, which facilitate the processing of complex data sets. Traditional biopharmaceutical applications for MS include protein molecular-weight…
Delivering Affordable Biologics from Gene to Vial
Miriam Monge (from Biopharm Services) revisits her March 2010 article (coauthored with Andrew Sinclair) in an audiocast with managing editor Maribel Rios. She reviewed the industry’s economic challenges at that time, which included costs associated with treatment, increasing market competition, and the rising demand for approved biosimilar products to offset healthcare costs. They wrote, “Many issues the biopharm sector faces appear to be the consequence of a maturing industry with structural impediments to its development brought about by regulation, political…
The Future of Protein A
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…