|
|
|
| The introduction of ICH Q14 to analytical procedure development provides guidance on the recommended approach to assay development and the justifications regulatory bodies require to demonstrate the development of a method. While applying an AQbD approach may require more upfront work, the advantages are a better understood and more robust method, with greater regulatory flexibility. Learn more about ICH Q14 and how proactive application can save time and cost over the method development life cycle. |
|
|
|
|
By Matthew Pillar, Editor, Bioprocess Online
| The challenges faced by ADC developers after a hundred-year history with the basic concept of the drug makes the recent billion-dollar bets on the modality look all the more dramatic. Where’s all this confidence coming from? It's not the antibody. It's not the payload. It's the linker. |
|
|
|
|
| Empowering Biopharma With Single-Use Cryopreservation Solutions | Article | By Ian Burdick and Evan Hagen, Charter Medical | Explore four common applications of cryopreservation and the science behind selecting the appropriate materials to build single-use solutions that enable cryogenic storage for cell and gene applications. |
|
|
|
|
|
|
|
|
|
| Bioprocess Online is excited to introduce Bio-Expo Live, a series of live virtual events designed to empower biopharma professionals with the chance to conveniently explore the newest equipment and offerings in Upstream Bioprocessing, Downstream Bioprocessing and Bioprocess Quality, Data, and Analytical Solutions. Registration is free, reserve your spot today! |
|
|
|
|
A conversation with Erich H. Bozenhardt, United Therapeutics | The ISPE sought to accelerate guideline development for allogeneic cell therapy. This discussion digs into the bigger themes in its recent guide. |
|
|
|
| Microbial Challenge In-Use Studies | White Paper | By Brent Harlow, Alcami | Learn more about how a partner with expertise can help you navigate the complex landscape of microbial challenge in-use studies and ensure the highest standards of patient care. |
|
|
|
|
| The Value Of Expertise In The Aseptic Fill/Finish Of Biologics | Article | By Jon Best, Jeff Tremain, Ted Tharp, and Gene Wloch, AbbVie | Aseptic fill/finish manufacturing is critical for highly valuable biologic drug substances. With vast amounts of time and resources invested upstream, loss-resulting errors at such a late stage can be catastrophic. |
|
|
|
|
|
|
|
|
|
|
|
| Complex protein-based therapies don’t play by the same process-engineering rules as small molecules and traditional biologics. They require developers to see the unforeseen and embrace new roles and responsibilities in sourcing raw materials and outsourced expertise. Successful developers can’t let this winding road slow their time to IND. Join Bioprocess Online Live on August 8th for an interactive discussion on early workflow considerations for complex protein-based therapeutics. Supported by Thermo Fisher Scientific. |
|
|
Connect With Bioprocess Online: |
|
|
|