Author Archives: BPI Staff

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December Spotlight

BPI Advisor Will Be Missed Thomas J. Pritchett, PhD (1950– 2016), was a member of the BioProcess International advisor board since its founding. He also was founder, publisher, and editor of the BioQuality Newsletter and provided decades of analytical and quality control training to many people in the biopharmaceutical industry, both on the industrial and regulatory sides. Pritchett always provided insightful, well–thoughtout approaches to implementing current good manufacturing practices (CGMPs) under all conditions, ranging from virtual to global companies. He…

Oliver Hardick (Puridify) and Cindy Jung (GlaxoSmithKline) accept the Best Collaboration award from BPI’s Anne Montgomery.

The 2016 BPI Awards: Honoring the People, Organizations, and Technologies in Global Biotherapeutics

Since 2003, the mission of BioProcess International has been to connect biopharmaceutical scientists and decision makers to the science, technology, and expertise that can positively influence and improve existing bioprocesses. Our BioProcess International Awards were created in 2012 to mark the magazine’s 10-year anniversary. They allow us to reflect on and help honor the time and investment companies put into researching, developing, and launching biopharmaceutical products, technologies, and services to deliver better, more efficient treatments and increased hope to a…

Spotlight for November

EU Workshop Report on Authorization of Advanced Therapy Medicinal Products The European Medicines Agency (EMA) published a report from a multi-stakeholder expert meeting held in May exploring ways to foster the development of ATMPs in Europe and expand patients’ access to these new treatments. ATMPs comprise gene therapies, tissue-engineered products, and somatic cell therapies. These medicines have the potential to reshape treatments of a wide range of conditions, particularly in diseases for which conventional approaches are inadequate. However, eight years…

Ask the Expert: Top Five Considerations in Outsourcing to a Biomanufacturing Partner

    with Paul Jorjorian In BPI’s 5 October 2016 webcast, Paul Jorjorian (director of global technology transfer at Patheon) discussed his top five considerations for companies outsourcing to a biomanufacturing partner. Jorjorian’s Presentation Selecting a contract and development manufacturing organization (CDMO) is an important decision for many biopharmaceutical companies. Beyond time and cost, here are some other criteria to consider. The number-one issue is quality. Is your company’s definition of quality the same as a CDMOs — and if…

Ask the Expert: Boosting Profits with Single-Use Powder Transfer

    with Chris Rombach Open-suite biomanufacturing is gaining popularity. But it leaves surfaces open to contamination, workers at risk for exposure to airborne particulates, and processes more exposed to product loss due to waste or spillage. Liquid-handling systems are often adapted for dry-powder applications, but flow rates, handling characteristics, and dispensing volumes differ dramatically. ILC Dover’s purpose-built, single-use EZ BioPac system is designed specifically to contain and release dry powders. With single-use bags engineered for the task, it can…

Ask the Expert: BioSC Continuous Chromatography of MAbs, Process Design and Regulatory Considerations

    with Vincent Monchois In our September webcast, Vincent Monchois (biopharma strategic project director at Novasep) discussed continuous chromatography using BioSC technology. He included regulatory considerations and the challenges of viral clearance that arise when companies switch from batch to continuous processes. Monchois’s Presentation Users can apply BioSC multicolumn, continuous chromatography to standard capture steps such as ion-exchange or protein A chromatography. The main advantages are continuous operation and full access to the total static capacity of a resin.…

October Spotlight

Adaptive Pathways Pilot Program Results A final report became available this past summer about the European Medicines Agency’s (EMA) pilot project on developing medicines for unmet needs. The project showed that adaptive pathways can bring multiple stakeholders together — including regulators, health-technology assessment (HTA) bodies, healthcare professionals, and patients — to evaluate drug development and data gathering. Adaptive pathways allow for a planned, progressive approach to bringing medicines to patients. The concept makes use of existing approval tools (e.g., conditional…

Ask the Expert: Christoph Herwig on Acceleration of Bioprocess Development Using DoE and Physiological Control

Acceleration of Bioprocess Development Using DoE and Physiological Control with Christoph Herwig Understanding the interdependencies among process variables, product quality attributes, and process parameters is key to achieving quality by design (QbD). Developers need to gather as much meaningful information as possible from their experiments. In a BPI “Ask the Expert” webinar on 7 August 2016, Professor Christoph Herwig of the Vienna University of Technology demonstrated how experiments based on physiological key parameters can be linked to design of experiment…

Ask the Expert: Ryan Boniface on Modification of Glycans in Bioprocessing

Modification of Glycans in Bioprocessing with Ryan Boniface Protein quality determines clinical behavior. Glycosylation is a key product quality attribute for many biotherapeutic proteins expressed by mammalian cells. N-linked glycans can display macro- and microheterogeneity with a degree of variation that depends on several factors. It’s often challenging to predict, achieve, and maintain preferred glycosylation profiles. For an “Ask the Expert” webinar on 15 June 2016, bioproduction scientist Ryan Boniface of Thermo Fisher Scientific explored approaches to modifying glycan patterns.…

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BioProcess International Announces Winners of the 2016 BioProcess International Awards

BioProcess International magazine today announced the winners for the 2016 BioProcess International Awards. The awards celebrate the outstanding achievements, collaborations, business strategies, social corporate responsibility and technology applications that will allow the industry to deliver better, more effective treatments to a global patient base. Winners and finalists were honored and recognized by their peers during a very entertaining and exciting awards dinner and ceremony Wednesday evening, 5 October at the Boston Convention and Exhibition Center in Boston, MA. “The BioProcess…