Newsletter | September 4, 2025

09.04.25 -- Is AI Making Biologics Outsourcing Smarter?

SPONSOR

Webinar: Nanoforming Biologics & GLP-1s: From I.V. to Sub Q & Inhaled Delivery

Discover how Nanoform's patented Bio platform is revolutionizing biologics and peptide delivery. In this webinar, explore two breakthrough case studies—subcutaneous Trastuzumab with improved stability and syringeability, and inhalable Semaglutide for deep lung delivery. Learn how these innovations can boost patient comfort, compliance, and outcomes. Don’t miss insights shaping the future of patient-friendly therapies. Click here to learn more.

INDUSTRY INSIGHTS

Regulatory Compliance And Audits For Parenteral Manufacturing Precision

CMOs play a critical role in regulatory compliance for parenteral manufacturing, using audits, quality systems, and proactive strategies to ensure product safety and patient well-being.

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.

Virtual Quality Audits — Serving Biopharma's Future

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.

FEATURED EDITORIAL

Hybrid. Continuous. Peptide. Manufacturing. Lilly's Put It All Together.

After reading part one with Lilly Kinsdale's Lorraine O'Shea, readers want to learn more about that facility’s “hybrid continuous manufacturing for peptides” technology. Chief Editor Louis Garguilo explores that technology with O'Shea, and ties it into thoughts of CDMO facilities as well.

Case Studies: Is AI Making Biologics And CGT Outsourcing Smarter?

This continues our discussion of AI and CDMOs, focusing on biologics and cell and gene therapy (CGT) relationships.

INDUSTRY INSIGHTS CONTINUED

Next Generation Sequencing In Viral Safety Testing

Next Generation Sequencing (NGS) offers a sensitive, high-throughput solution for detecting adventitious viral agents (AVAs), improving safety and accelerating regulatory-compliant product development.

Advancements In Microbial Manufacturing Of Biopharmaceuticals

Dive into the evolution and future potential of microbial manufacturing in the biopharmaceutical industry to discover how digital tools can revolutionize development and production processes.

Considerations And Options For Prefilled Syringes

Explore the benefits of prefilled syringes to enhance product convenience, reduce drug waste, and streamline your pharmaceutical manufacturing process.

Leveraging Transposase Technologies To Optimize Cell Line Development

Enable a wide array of genomic manipulation with the more regulated and efficient genomic insertion that's made possible by transposase-based technologies.

Elevating Purity: Racemizing Pharmaceutical Products In Flow Microreactors

Discover how our process development team resolved a racemization challenge by delivering a biologically active racemic mixture while maintaining compound purity.

Can You Simplify Device Decisions And Stand Out From Competition?

Evaluating your system’s performance and compatibility earlier in development can ensure you have a viable product to support development phases.

Development, Manufacture Of Biopharmaceuticals In Microbial Systems

We discuss the trends in new molecular formats, which is one of the current drivers of renewed interest in fermentation technologies, along with some of their challenges. 

SOLUTIONS

Comprehensive Manufacturing Solutions Backed By Global Expertise

Gain insight into a CDMO with global, end-to-end mammalian manufacturing solutions, flexible capacity, and a strong track record in regulatory compliance that can support your company's needs.

Contract GMP Biologics Analytical Services

Pedro Morales, Director, Scientific Advisor of Biologics Analytical Services, shares more on the process to deliver tailored solutions through deep expertise and advanced capabilities.

End-To-End Clinical And Commercial Manufacturing Support

Discover a robust manufacturing platform that is meticulously designed to produce high-quality biologic drug substance. Each unit operation is carried out under strict cGMP conditions.

Dream Plant: Within Your Reach. Built For Your Success.

As pressure to accelerate timelines mounts, finding a CDMO committed to increasing capacity and optimizing processes is key for adding efficiency while maintaining high quality standards.

Integrated ADC Offering: From Concept To Commercialization

Leveraging deep ADC expertise and experience, successfully develop high quality, commercially viable processes, spanning from pre-clinical development through commercial scale manufacturing.

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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