Friday, June 14, 2019 Daily Archives

Product Robustness, Integrity Testing Science and Technologies for Enhanced Process Integrity and Patient Safety

by

This webcast features: Carole Langlois, Marketing Manager, Traditional Vaccines, and Marc Hogreve, Senior Engineer Integrity Testing, at Sartorius Stedim Biotech With the expansion of Single Use Systems (SUS) in all process steps of commercial manufacturing, integrity failure can significantly impact drug safety, availability and costs. Consequently, there is an increasing industry scrutiny on single-use container closure integrity (SU CCI), raising the need to develop good science behind liquid leakage and microbial ingress and appropriate physical integrity testing technologies. The presenters…

June 14, 2019

eBook: Efficient Production of Adherent Cells – The Bolt-On Bioreactor Project, Next Phase

by , and

Some years ago, The Bolt-on Bioreactor (BoB) project was launched with an objective of bringing to the market an efficient bioreactor for culturing adherent cells. The BoB team identified four challenges that needed be addressed to succeed: volumetric productivity, process automation, containment and sterility, and process economics. BPI published findings related to those challenges and proposals of the BoB team to solve them in a four-article series in 2015. Here, the author offers an update on developments in The Bolt-on…

June 14, 2019

Middle class: Lonza on the flexibility of midscale biomanufacturing

by

With construction of a 6,000 L scale hybrid plant underway, CDMO Lonza says there is high demand among its customers for midscale biomanufacturing. In this industry, companies and commentators like talking about extremes: either small-scale single-use or large-scale stainless steel. But speaking at the BPI Theater at BIO in Philadelphia earlier this month, Stéphane Varray, commercial development for midscale at Lonza Pharma and Biotech said midscale options provide firms with flexibility across numerous modalities. “When we look at midscale we’re…

June 14, 2019

Fujifilm tackles buffer bottleneck at $10m continuous processing plant

by

Fujifilm Diosynth Biotechnologies says it can overcome the burden of large buffer volumes associated with continuous purification as part of a new UK processing facility. The facility in Billingham, UK will include a 500 L single-use perfusion bioreactor and 7 downstream processing units and is expected to begin offering process development later this year. The plant represents a $10 million (€8.9 million) investment by the contract development and manufacturing organization (CDMO) and is the culmination of three years of in-house…

June 14, 2019

America has 20 approved biosimilars but you’ll never believe how many have launched!

by

With the FDA approving Amgen And Allergan’s version of Roche’s Herceptin (trastuzumab) America’s biosimilar tally has reached 20… But only seven have reached the market. Clickbait headline aside, this week marks another major milestone in the US biosimilar market: the approval of its twentieth biosimilar Kanjinti (trastuzumab-anns), a version of Roche’s cancer monoclonal antibody Herceptin developed by Amgen and Allergan. The approval is the third in Amgen’s portfolio and the second of four biosimilars from an Amgen and Allergan collaboration…

June 14, 2019