Newsletter | July 11, 2025

07.11.25 -- Amgen Bets On Agility In The Age Of AI

SPONSOR

Webinar: Mitigating Global Disruptions With Redundancy In Upstream Cell Culture Media Supply

Potential delays or shortages in securing critical raw materials can impact production timelines and efficiency — threatening the pharmaceutical industry's ability to meet global health needs. Learn best practices around outsourcing, primary and secondary media supply and how Thermo Fisher is helping ensure consistent Gibco™ media quality and on-time delivery on a global scale. Click here to learn more.

FOCUS ON PROCESS ENGINEERING

Amgen Bets On Agility In The Age Of AI

The company is speeding up process optimization with tools like predictive analytics, digital twins, and generative AI copilots.

How CGT Leaders Are Reducing Failures, Scaling Processes, And Overcoming Regulatory Friction

 Industry leaders share their philosophy on reducing product failure, embracing AI, and building dynamic teams to stay ahead of the curve to bring curative CGT therapies to patients.

Predictive Modeling Of Concentration-Dependent Viscosity Behavior

Review a modeling approach employing artificial neural networks using experimental factors combined with simulation-derived parameters plus viscosity data from 27 highly concentrated mAbs.

Optimized Production Of Recombinant Proteins

Advancements in recombinant protein production have improved efficiency and quality. Yet, optimizing cell culture media remains crucial to ensuring maximized yield and desirable product attributes.

Solid State Hydrogen Deuterium Exchange To Study ADC Stability

Discover how this solid-state HDX-MS is being used to revolutionize the prediction of stability for IgG-based Antibody Drug Conjugates and enhance ADC development processes.

Leveraging Advanced Analytical Capabilities To De-Risk Drug Development

Characterizing a molecule's identity enables efficient process development and regulatory compliance. To achieve this, sponsors must leverage advanced analytical techniques that illuminate structure and purity.

Detergent-Based Viral Inactivation

Need to change your viral inactivation method due to environmental concerns? Don’t underestimate how long it will take to change your process.

Reaching BLA Success: Fast-Track Approach To Process Characterization

Discover how knowledge of microbial processes and process characterization understanding can be used to design targeted BLA programs while managing risks.

Optimizing Monoclonal Antibody Manufacturing For Commercial Success

Strategically optimize your upstream and downstream processes and decrease the timeline from optimization to commercial manufacturing.

Complexities And Pitfalls Associated With cGMP Tissue Sourcing

Review the elements of a complex process, prone to misconceptions and pitfalls, to find the “right human tissue” that will yield the desired cell quality and quantity and pass BLA approval.

The Chemistry Of Aqueous Cleaning

In this chapter of The Aqueous Cleaning Handbook, we explore the key definitions of aqueous cleaner ingredients, the types of aqueous cleaners, and the application of isoelectric points to cleaning.

Setting The Right Shaker Parameters For Cultivation Success

Precise control over shaker parameters is vital in bioprocessing. Learn to tailor cultivation environments, maximizing efficiency and reproducibility for diverse cell types effectively.

PROCESS ENGINEERING SOLUTIONS

Easy-To-Use 1 mL Disposable Autoinjector - BD Medical - Pharmaceutical Systems

Setting The Foundation Of Success In Your Drug Development - Labcorp Biopharmaceutical CMC Services

Effectively Enabling Rare Diseases To Reach Patients - FUJIFILM Biotechnologies

Process Lifecycle Management For Optimized Drug Development, Tech Transfer - IDBS

Customized CMC Solutions - Samsung Biologics

SPONSOR

The PDA Regulatory Conference 2025 Achieving CGMP Excellence: Sustainable Compliance Across the Lifecycle continues its 34-year tradition of delivering impactful content that supports the development and implementation of effective quality systems across the product lifecycle. This premier pharmaceutical CGMP conference on 08-10 September 2025 in Washington, DC will focus on strategies to manage manufacturing and quality risks while driving operational excellence and sustainable compliance.

FOCUS ON SUPPLY CHAIN

Friendshoring: A Strategic Shift In Pharma Supply Chains

To safeguard the consistent delivery of essential therapies to patients around the world, biopharmaceutical companies, alongside their CDMO partners, are rethinking traditional supply models.

Trends In Cold Chain Storage For Biologics

Packaging is critical, as biotechnology products requiring colder storage become more valuable. Find out how you can improve your temperature-controlled supply chain and meet cold chain storage demands.

A Practical Guide To Help Choose The Right Cold Storage Solutions

Cold storage units like refrigerators, freezers, and ULT freezers are vital to scientific progress, which preserves sensitive materials and supports breakthroughs in medicine, especially amid the rise of cell and gene therapies.

SPONSOR

Single-use systems (SUS) are everywhere—but standardization hasn’t caught up. Join Bioprocess Online Live for a timely discussion on how the lack of SUS standards is impacting implementation, tech transfer, and supply chain stability—and what the industry must do next. Registration is free thanks to the support of CPC.

SUPPLY CHAIN SOLUTIONS

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

Connect With Bioprocess Online: