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.…

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…

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…

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…