Newsletter | July 19, 2024

07.19.24 -- Antibodies, Linkers, An Uber, And John Wick

SPONSOR

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.

FOCUS ON SUPPLY CHAIN

Antibodies, Linkers, An Uber, And John Wick

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.

Improving Biomanufacturing Resilience In An Uncertain Future

Three experts discuss the role and value of collaborations and what strategies can be used to help improve biomanufacturing resilience in an unpredictable but promising future.

PTFE Containment: Viable For Temperature-Sensitive Protection

Single-use cold-chain containers made with polytetrafluoroethylene fluoropolymers may be less susceptible to failure and breakage at cold temperatures.

Empowering Biopharma With Single-Use Cryopreservation Solutions

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.

Stressing Cells: The Role Of Cryoprotectants In ATMP Cryopreservation

Explore the challenges of adding cryoprotectants, how they can help reduce the effects of harmful conditions like ice crystals, and the need for future stability studies and substitutes for toxic CPAs.

SUPPLY CHAIN SOLUTIONS

Supporting Bench To Production Applications - Thermo Fisher Scientific Bioproduction

Single-Use Flexible Freeze Container - W.L. Gore & Associates

SPONSOR

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!

FOCUS ON FILL-FINISH

New Guide Tackles Best Practices For Making Allogeneic Cell Therapies

The ISPE sought to accelerate guideline development for allogeneic cell therapy. This discussion digs into the bigger themes in its recent guide.

The Benefits Of End-To-End Formulation And Fill/Finish Of Biologics

Proper formulation development has a huge impact on whether a technology transfer to clinical phase fill/finish is successful. Review the challenges of transitioning a promising drug candidate.

Microbial Challenge In-Use Studies

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.

Theory Of DSC And Applications In Lyophilization Processes

In this episode, Austin Ryan, Ph.D., reviews how DSC works and provides background on the MDSC technique, what it does, and how it can be useful in lyophilization applications.

Glass Vials To Evolve Your Sustainability Goals

Learn more about new glass vial options that combine performance and sustainability to help pave the way to a greener future.

The Value Of Expertise In The Aseptic Fill/Finish Of Biologics

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.

FILL-FINISH SOLUTIONS

Closed Robotic Isolator For Pharmaceutical Vial Filling - Cytiva

Automate Your Fill And Finish Process For Precision - Terumo BCT

Pharma+ Tubing Retainers - Nordson MEDICAL

Capacity Update May 2024: Fill/Finish - Pfizer CentreOne

Drug Product Manufacturing: Yield-Maximizing Technology - Argonaut Manufacturing Services

SPONSOR

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: