Newsletter | August 25, 2025

08.25.25 -- Biopharma Manufacturing Outsourcing Is Flexible, Not Fractured

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

Navigating OOX Results: Effective Analysis, Management In CDMO Labs

By prioritizing the management of Out of Expectation (OOX) results within your CDMO laboratory, learn how you can ensure product integrity, patient safety, and unwavering regulatory compliance.

The Pathway To Operational Readiness

Ready to ensure your facilities, systems, and teams are prepared for success? Discover a proven framework to accelerate operational readiness, mitigate risks, and achieve sustainable results.

Miniaturize In Vitro Assays To Achieve Superior And Cost-Efficient Results

Review a study showcasing the successful application of miniaturized biochemical assays to screen a diverse range of drug candidates against multiple target molecules.

FEATURED EDITORIAL

Biopharma Manufacturing Outsourcing Is Flexible, Not Fractured

An element of the 2025 BioPlan Associates annual report and survey took Chief Editor Louis Garguilo by surprise. The report intimates that biopharmaceutical manufacturing faces a fractured CDMO market. Despite solid data to back that assertion up, Garguilo presents a very different view, one based on what many readers have expressed.

A Flexible Mindset For Bridging Between Cell-Based Assay Groups

Transferring cell-based assays for biologics starts with defining operator and equipment parameters, positive and negative controls, and a sufficient dynamic range.

INDUSTRY INSIGHTS CONTINUED

Accelerating Drug Development: Flexible And Fast DNA-To-IND Programs

Gain expert insights on how tailored approaches and innovative technologies enable fast and flexible development workflows, ultimately supporting rapid therapeutic breakthroughs.

Enhancing Patient Adherence Through Autoinjector Access

As autoinjectors evolve to accommodate a diverse array of chronic diseases, consider the impact of partnering with experienced device manufacturers and fill/finish providers.

Innovative ASD Technology Improves Abandoned Cancer Medication

Would changing the ASD particle structure and lowering drug load improve outcomes? Learn how one solid dispersion technology lowered pill burdens and demonstrated an improved therapeutic response.

Seasonal Vaccine Manufacturing: 3 Areas To Evaluate When Selecting A Partner

Experienced outsourcing partners will have the right facility and technical capabilities, a culture of speed and execution, and shared expectations and commitment to continuous improvement.

Optimized Transient Production: Faster Preclinical Studies With Enhanced QC

Accelerate your path from discovery to clinic by leveraging high-quality plasmid DNA, optimized expression systems, and early developability assessments to streamline transient protein production.

Reducing ADC Timelines With Integrated Development And Manufacturing

ADCs have proven to be highly effective in cancer treatment, but their manufacturing poses challenges. Learn how a CDMO partner can help bring these treatments to patients safely and efficiently.

Scale Your Vaccine Development With Path-To-PAD

Delve into the details of this straightforward approach to maximize yields early in development, leveraging vaccine expertise, robust platforms, and Vero and Quail cell lines.

SPONSOR

Webinar: Building Quality by Design for Multi-Specific Therapeutic Proteins

This Lonza webinar explores the development of multi-specific biotherapeutics, which offer enhanced efficacy but pose manufacturing challenges. Lonza’s toolbox approach—featuring in silico developability screening, vector design, the GS Gene Expression System®, and immune cell assays—enables early risk assessment of manufacturability and immunosafety. This helps streamline candidate selection and accelerate timelines into clinical development. Click here to learn more.

SOLUTIONS

Double-Stranded mRNA Testing By ELISA

Uncover how accurate detection of toxic double-stranded RNA impurities is critical in mRNA drug development, and expert ELISA-based solutions that support safe, effective therapeutic release.

Leveraging Advanced Technology And Proven Expertise

By leveraging our proprietary non-viral gene insertion technology, GPEx® Lightning ensures rapid development timelines and high-yield production, making it an ideal solution for complex biologics.

60 Years Of Providing Manufacturing Solutions To Patients

Explore why our partners trust us to produce safe, high-quality injectable pharmaceuticals, and where the company plans to head next.

Comprehensive Services Ranging From Early Phase To Finished Products

Discover on-site managed laboratory and manufacturing services, covering everything from R&D to QC, method development, and regulatory support, without headcount or compliance burdens.

Large Molecule Expertise. Ingenuity You Can Count On.

As a fully integrated CDMO, we offer a comprehensive suite of services, from early-stage research to robust commercial manufacturing, within our state-of-the-art facilities.

Drug Product Manufacturing: Yield-Maximizing Technology

Our drug product manufacturing services provide the features you need to protect your high-value drug substance. Fully-automated filling within SKAN isolators meets stringent regulatory 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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