Newsletter | March 4, 2025

03.04.25 -- ADC Manufacturing's Biggest CMC Challenges And Ways To Approach Them

SPONSOR

Webinar: Harnessing AI, Spatial Transcriptomics & Mass Spectrometry for Clinical Insights: A game changer in the prediction of drug treatment responses at the cellular level

This webinar covers how preserving spatial molecular information enhances tissue analysis. It explores spatial-Omics platforms, AI models predicting treatment responses, and identifying patient subgroups. Topics include spatial-omics integration, AI-driven predictions, oncology applications, and improving molecular signatures for personalized medicine. Click here to learn more.

FOCUS ON OUTSOURCING

ADC Manufacturing's Biggest CMC Challenges And Ways To Approach Them

Manufacturing ADCs is inherently more complex than other biologic drug products. Let's explore some of the key issues, including aggregation, solubility, and thermal instability.

Integrating Advocacy Into The Cell & Gene Therapy Supply Chain

Treating advocacy as an institutional priority provides tangible benefits for Aldevron’s team members, our clients, and, most importantly, the patients waiting for these potential breakthroughs.

Choosing A CDMO: Three Considerations For New Drug Developers

The greatest challenge in drug development can be finding a team capable of carrying a molecule through the complexities that lie between the research lab and the patient’s bedside. Discover three considerations that build a foundation for partnership.

Virtual Quality Audits — Overcoming Pandemic Limitations

A properly executed virtual audit facilitates thorough qualification, condenses production timelines, enhances relationship-building, and provides early insight into a CDMO’s capability and expertise.

Choose The Right CDMO To Guide Your Biologic To Regulatory Success

If you are wondering when to begin your CDMO search, the answer is simple: the sooner the better. Partnering with a CDMO early helps ensure later success.

Breaking Barriers: Streamlining The Path To FIH

Explore how KBI Biopharma’s SUREtechnology Platform, powered by Selexis, accelerates the development of complex biologics from early stages to first-in-human (FIH) trials, focusing on both speed and quality.

Building A Strong Safety Culture In The Biopharmaceutical Industry

Explore how fostering a strong safety culture — rooted in accountability, collaboration, and proactive risk management — can drive operational excellence and long-term success in biopharmaceuticals.

How This CDMO Model Is Empowering Emerging Biotechs

For emerging biotechs looking to refine their development processes and boost their chances of commercial success, exploring these partnership opportunities could prove invaluable.

SPONSOR

Unlock the future of advanced therapy medicinal products and antibody-drug conjugates using advanced analytics at the 2025 ISPE Aseptic Conference, taking place March 17-18 in Washington D.C., United States and virtually. Breakout sessions and panel discussions will focus on the following tracks: Advanced Modalities; Advanced Therapy Medicinal Products (ATMPs); Case Studies; Filling Operations; Regulations and Pharma 4.0™; Sterility and Release. Learn more and register.

OUTSOURCING SOLUTIONS

Simtra Capabilities Overview - Simtra BioPharma Solutions

Container Closure Integrity Testing - Lonza

Solutions For Delivering Complex Biologics - BD Medical - Pharmaceutical Systems

Capacity Update July 2024: Large Molecule Development - Aton Biotech

Navigating The Future: For Each And Every Patient - GC Cell

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