Author Archives: BPI Staff

Drug-Product Development – BioProcess International Conference & Exposition 2015

What’s on the minds of groups involved in drug-product manufacturing in 2015? They’re applying quality by design (QbD) principles and process analytical technology (PAT) to formulation and fill–finish. High- throughput and single-use technologies are helping them improve process economics as well as sterility and flexibility. Formulators are redrawing the lines between drug substance and drug product manufacturing, especially when it comes to preformulation analysis. Fill–finish groups are working out the details of new types of container– closures and delivery devices.…

Featured Products and Services

Accelerator Development Services Applications: Bioprocess consulting, process development, and qualification Features: Pall Life Sciences supports customers with an experienced team of scientists and engineers — from on-site guidance to larger projects in its own process development laboratories. PadReactor® Single-Use Bioreactors Applications: Flexible for suspension- adapted and adherent cell cultures Features: The PadReactor family of single-use bioreactors is designed for cell culture applications. These systems are linearly scalable (5–1,000 L) and suited from laboratory-scale process development to large-scale GMP manufacturing. They…

e-Book: QbD Manufacturing Strategies — The CMC Strategy Forum Series, Part 2

The CMC Strategy Forums provide a venue for biopharmaceutical product discussion. They focus on relevant chemistry, manufacturing, and controls (CMC) issues throughout the life cycle of a therapeutic and thereby foster collaborative technical and regulatory interaction. Forum chairs share information with regulatory agencies to help them merge good scientific and regulatory practices. Outcomes of the forum meetings are published in BioProcess International and on the CASSS website. This process is meant to help ensure that biopharmaceutical products manufactured with advancing…

Spotlight

BioProcess Development Week 2015 by Maribel Rios From 30 March to 2 April 2015, more than 750 professionals gathered at the Hyatt Regency Resort in Huntington Beach, CA, to attend the annual Biopharmaceutical Development and Production meeting. Organized by IBC Life Sciences, BDP Week provided attendees with keynote addresses and sessions on the state of the bioprocessing industry and hot technical topics as well as preconference workshops, exhibit hall networking opportunities, poster presentations, and keynote addresses from five bioindustry leaders.…

BPI European Summit 2015 Poster Hall Award Winners Announced

BioProcess International magazine is pleased to announce the winners of the BioProcess International European Summit Poster Hall awards. The winning poster in the Supplier category is Identification and Characterization of Raw Materials Using FTIR and ICP-MS for Bioproduction Application, by Duncan Omune, PhD; Nuvjeevan S. Dosanjh, PhD; Yingtao Chai, PhD; Ronald Sanford, Darryl Dickerson, and Elizabeth C. Dodson, PhD from BD Advanced Bioprocessing in Maryland, USA. This poster highlights an advance in analytical method development and presents its application to…

Spotlight

Niche-Disease: Pompe’s Disease by Cheryl Scott Pompe’s disease is a genetic disorder that causes a cellular buildup of the complex sugar glycogen. Its accumulation in organs and tissues impairs their ability to function normally. Since the disorder was identified in 1932 by Dutch pathologist J.C. Pompe, researchers have classified three forms of Pompe disease (also called glycogen storage disease type II or acid maltase deficiency): classic infantile-onset, nonclassic infantile-onset, and late-onset. The disease is inherited in an autosomal recessive pattern.…

Spotlight – March 2015

Niche-Disease: Fanconi Anemia by Cheryl Scott Fanconi anemia (FA) is a rare, genetic blood disorder that causes bone-marrow failure. It prevents bone marrow from producing sufficient new blood cells and/or makes it produce faulty blood cells. Although FA is a blood disorder, it can affect many organs, tissues, and systems. Children who inherit the condition are at higher risk of being born with birth defects. It is a complex and chronic disorder that can be psychologically demanding. FA is not…

Ask the Expert – 2D DIGE Western Blots for HCP Detection and Coverage Determination: Advantages of Fluorescence over Colorimetric Detection

with Jamina Fiedler, BioGenes GmbH Biopharmaceutical products must be free of by-products (such as host-cell proteins, HCPs) for approval by authorities such as the US FDA. For that, a clear proof is required of sufficient HCP detection by the HCP assay used. The two-dimensional (2D) DIGE Western blot method is the standard technique for detection of HCP coverage. Colorimetric detection has several limitations that can be overcome by the use of fluorescent detection. Jamina’s Presentation Practical differences between 2D DIGE…

Poster Hall and Awards Set to Launch at INTERPHEX 2015

International Pharmaceutical Expo (INTERPHEX), the premier pharmaceutical and biopharmaceutical event dedicated to innovation, technology and knowledge, and sponsored by the Parenteral Drug Association (PDA), and BioProcess International, a monthly magazine devoted to the development, scale-up, and manufacture of biotherapeutics and biodiagnostics, today announced the addition of a Poster Hall held during INTERPHEX 2015 taking place April 21-23, Javits Center, New York, New York. Posters will be available on the show floor on Tuesday and Wednesday, April 21-22 from 9:00am-5:00pm. A…