Newsletter | July 7, 2025

07.07.25 -- Why CDMOs Are Leaving Small Molecules Behind

INDUSTRY INSIGHTS

Transitioning From A Vial To PFS Or Cartridge In An Auto-Injector Device

Explore how to approach the transition of migrating from a vial to a syringe or cartridge, the necessary compatibility testing, and the stresses on the bulk product during formulation and filling.

Challenges Associated With In-Use Simulated Administration Of Biologics

Examine some of the more challenging aspects surrounding in-use testing for parenteral delivery, along with potential strategies to address these issues.

CHO Cell Lines For Recombinant Protein Production

Discover how new strategies are driving innovation and transforming the future of biologics manufacturing, from enhanced productivity to improved therapeutic quality.

FEATURED EDITORIAL

Why CDMOs Are Leaving Small Molecules Behind

It’s rare when a CDMO’s market restructuring leads to thoughts about national health policy. But as Chief Editor Louis Garguilo wrote his recent editorial on Lonza’s decision to focus on biologics, it brought to mind a government policy that may have contributed to the company’s restructuring. No, it's not tariffs.

When Outsourcing, Take Advantage Of Each Other's Strengths

Bikash Chatterjee, President and Chief Science Officer, Pharmatech Associates, says sponsors and CDMOs have different business models and strengths, and that is a good thing to exploit.

INDUSTRY INSIGHTS CONTINUED

Designing A Microbiological Performance Qualification For Facilities

Observe five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.

Could Traceability Be Key To Operational Excellence?

Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address risks and costly bottlenecks related to the fill-finish process.

Extractables And Leachables: Setting Up Early For Success With Your CDMO

Consider insights tailored specifically for drug product researchers and manufacturers, offering key knowledge on extractables, leachables, and effective implementation strategies.

Vial Fogging: Practical Considerations For Vial Selection

Witness a common phenomenon observed in lyophilized biologic drug products. These case studies examine critical factors that contribute to vial fogging and vial selection.

Achieving Rapid, High-Titer Expression For Next-Generation Biologics

This advanced cell line development technology overcomes production challenges related to the expression and scalability of complex biologics.

Streamline The Path To FIH Trials With Advanced Cell Line Development

Learn why many CDMOs cannot handle complex recombinant proteins, which often require a CLD process fully integrated with other CDMO components, including analytics and formulation development.

SOLUTIONS

Accelerating CGT With Speed, Cost, And Innovation Advantages

Our compact, efficient facility delivers rapid, cost-effective viral vector manufacturing and development services powered by deep industry expertise.

Antibody Drug Conjugates: Link Your Antibody To Its Fullest Potential

Review how our parallel development service works seamlessly with our existing antibody capabilities, helping to accelerate your ADC program and reach market faster.

A Look At Innovation In Pharmaceutical Development

Take a virtual tour of our advanced facilities, including KinetiSol™ technology, and discover how we enable scalable, sustainable performance.

Our Biotech Success

Surrozen was keen to get started on process development and manufacturing and needed a CDMO with experience developing and producing bispecific antibodies and fusion proteins.

Drug Product Filtration System

Investigate a fully automated sterile filtration system with built-in PUPSIT, enhanced product recovery, and configurable recipes designed to meet EU GMP Annex 1 contamination control requirements.

OUTSOURCED PHARMA CAPACITY UPDATE

Find Your New CDMO At Outsourced Pharma Capacity Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capacities. See for yourself why this virtual event has become a wildly popular resource to identify options for your development and manufacturing needs.

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