Qualitative and quantitative analyses of process-related impurities are critical to manufacturing a safe, high-quality drug product. During his 17 June 2020 “Ask the Expert†webcast, Steven Broome (BioPharmaSpec) described using mass spectrometry (MS) for such analyses. Focusing on isopropyl-β-D-thiogalactopyranoside (IPTG), kanamycin, and host-cell proteins (HCPs), Broome overviewed best practices for using MS to detect and quantitate low levels of impurities. Broome’s Presentation Chemicals used in biotherapeutic production can be present as impurities in the resulting drug product. These impurities can…
Wednesday, October 28, 2020 Daily Archives
Enabling Increased Performance, Robustness, and Safety in Single-Use Bioreactors
This webcast features: Lara Nascimento-Brooks, Product Manager, Sartorius Stedim Biotech The discussion will focus around three relevant themes for bioprocess development on single-use bioreactors: performance, robustness, and safety. An initial overview of the current landscape developments in the biopharmaceutical industry highlights that bioprocesses should remain flexible enough in order to accommodate intensification and reduce further time-to-market. With this in mind we will discuss key aspects of bioreactor performance improvement in order to achieve that goal. Additionally, processes must remain sufficiently…
Repligen strengthens downstream offering with $200m ARTeSYN acquisition
Repligen says it has established itself as a premier player in single-use systems, integrated flow paths, and assemblies following a triumvirate of bolt-on acquisitions. According to Repligen Corporation, ARTeSYN Biosolutions’ single-use chromatography and filtration systems are considered “the gold standards in downstream bioprocessing.†The technologies – along with three manufacturing facilities in Ireland, Estonia, and California – are soon to become part of Repligen’s offering after the firm entered a definitive agreement to buy ARTeSYN for $130 million cash and…
Lilly confident in remediating troubled COVID mAb plant
Eli Lilly has engaged an external firm to conduct a comprehensive independent review after the FDA found data integrity issues at a manufacturing facility in New Jersey. Earlier this month, Reuters broke the news that the US Food and Drug Administration (FDA) issued Eli Lilly’s Branchburg, New Jersey manufacturing site with an “Official Action Indicated†(OAI) notice. This came after an inspection in November last year found that processing data had been deleted and not appropriately reviewed by the firm’s…
Novartis awaiting Italian plant inspection for FDA’s Leqvio decision
Novartis is confident of maintaining a December 2020 action date for its high cholesterol siRNA therapy Leqvio despite common COVID-related regulatory delays of three to five months. Earlier this month, Novartis received positive opinion from the European Medicines Agency (EMA) for Leqvio (inclisiran), a small interfering RNA (siRNA) therapy for the treatment of adults with hypercholesterolemia or mixed dyslipidemia. The Swiss pharma giant is hoping for the same in the US, with a PDUFA date set for December 31 2020…