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…
Author Archives: BPI Staff
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.…
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…
September Spotlight
Women In Bio Launches Executive-Level Certification Program To prepare women in life sciences for roles on boards of directors, the national Women in Bio (WIB) organization has launched a program for executive-level board certification. “Women are significantly underrepresented on the boards of life science companies,†says Kristi Sarno, national president of the group, “and the Boardroom Ready program will ensure that more women are qualified, willing, and proactively seeking board memberships. This new initiative is an important step toward promoting…
BioProcess International Announces Finalists for the 2016 BioProcess International Awards
BioProcess International (BPI), the biopharmaceutical industry’s leading business-to-business publication, today announced the finalists for the 2016 BioProcess International Awards. The awards celebrate the outstanding individual and team achievements, recognize emerging companies and their technologies, highlight groundbreaking business collaborations and strategies, corporate responsibility and technology applications that will allow the industry to deliver better, more effective treatments to a global patient base. Award winners and finalists, individually voted on and ranked by the 2016 BPI Awards Judging committee from 125+ nominations…
Spotlight
Infectious Agents: A Global Effort Worldwide Commitment to Fight Antimicrobial Resistance: Medical, business, and government officials from around the world gathered in Amsterdam for the ECCMID 2016 Conference in April 2016. Hosted by the European Society of Clinical Microbiology and Infectious Diseases (ESCMID), the meeting reinforced its attendees’ commitment to fight antimicrobial resistance in a concerted effort. During an interactive session hosted by ESCMID and the Netherlands Society of Medical Microbiology (NVMM), researchers and representatives of the Dutch healthcare administration…
Ask the Expert Liposome and Viral Vector Characterization: Use of Electron Microscopy and Image Analysis
with Dr. Josefina Nilsson For this webcast, Josefina Nilsson (EM Services business unit head) discussed Vironova’s work, including case studies. She focused on characterization of drug and gene delivery platforms with electron microscopy and image analysis, specifically for systems that use viral vectors or liposomes. Along with two colleagues — Gustaf Kylberg (image analysis expert) and Mathieu Colomb-Delsuc (electron microscopist) — she then answered questions from the audience. Nilsson’s Presentation Structural characterization provides important insights into the quality of development and…