Podcasts

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…

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 —…

Culture Media: Sourcing Animal-Free Raw Materials

For September’s Ask the Expert, we talked to Bill Whitford (senior manager of the bioprocess market for Thermo Fisher Scientific) about sourcing animal-free raw materials for cell culture media. This has become a requirement for many biopharmaceutical sponsors, but it is not without its issues. But what precisely is meant by animal is not always clear. Regulatory guidance is sparse on this issue. And a designation of animal-derived–component free (ADCF) often involves additional certification, testing, or auditing. Sponsors and material…

Reducing Tech-Transfer Risk

Process understanding is the key to mitigating risks associated with technology transfer. In 2007, Justin Neway provided strategies for combining on-demand data access, trending, reporting, and analytics to achieve that understanding throughout process development (pdf). With increasing adaptation of process analytical technology (PAT) and quality-by-design (QbD), process understanding strategies have shifted.

Cell Therapies Roundtable: Building the Pillars to Success

In order to deliver cell-based therapies on a commercial scale, cell therapy companies and suppliers must form partnerships in order to overcome existing manufacturing, regulatory, and analytical challenges. Four leading cell therapy experts discuss what is and what has to be done in order to accomplish this objective.