Newsletter | September 15, 2025

09.15.25 -- Paying For Lots Of Formulation Work At Your CDMO

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AAPS PharmSci 360 delivers research spanning the pharmaceutical pipeline, from discovery to manufacturing to delivery. Thousands of scientists and decision-makers from across the globe converge to discuss cutting-edge breakthroughs, technologies, and techniques at this science-first event. Join your colleagues for the latest in pharmaceutical science in San Antonio, Texas, November 9-12, 2025. Register today!

INDUSTRY INSIGHTS

NIH:OVCAR-3 Human Ovarian Cancer Model

Evaluate several studies using the NIH:OVCAR-3 model of human ovarian cancer in the subcutaneous setting in NSG mice with multiple standard agents and vehicles.

A New Look At Subcutaneous mAb Delivery Using Nanoformed Particles

A highly concentrated non-aqueous suspension of an IgG1 was developed using a patented platform. Review how the particle size of the mAb impacts the overall behavior of the drug product.

Computational Modeling Of Injection-Related Tissue Responses

Optimizing delivery along with the formulation is the key to successful clinical outcomes. Research is necessary to understand the relationship between body morphology, injection force, and needle length.

FEATURED EDITORIAL

Paying For Lots Of Formulation Work At Your CDMO

We’ve investigated the outsourcing of early-to-commercial drug formulation strategies. So how do you pay for all that work? For specific answers and examples, Chief Editor Louis Garguilo turns to Dileep Boinipally at Metsura. He starts with the "usual method of payments" - fee-for-service (FFS), but adds plenty of options and strategies.

Report: Nearly 40% Of Biomanufacturers Eyeing Continuous Processing

Continuous perfusion manufacturing came about before the technology was mature enough to support it. Now, new data suggests an inflection point in the status quo.

INDUSTRY INSIGHTS CONTINUED

Leak Rate Testing for Freeze Dryers: A Scientific Approach

What is the maximum volume of air that can leak into the freeze-dryer without violating the Class 100 / Grade A microbial specifications? A method was developed to measure the exact void volume of a dryer.

Bridging The Gap During Organizational Restructuring For Long Term Continuity

Explore project continuity for a pharmaceutical client during restructuring by providing trained on-site experts, implementing operational excellence, and meeting milestones despite senior staff turnover.

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.

A Streamlined Path To FIH: Optimizing Cell Line, Process Development Workflows

Process development experts discuss how advanced cell line development and transposase technology streamline the path to toxicology and first-in-human studies.

Charting A Successful CMC Journey For Your ADC Drug Product

These real-world case studies highlight best practices and strategies to optimize bioconjugate drug product tech transfers and supplies in the clinical or commercial phase.

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.

SOLUTIONS

Support Through All Phases Of Development

Find laboratory services that can support many drug substance or drug product modalities, all product phases, and numerous specialty laboratory services.

Antibody Drug Conjugates: Link Your Antibody To Its Fullest Potential

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

Providing Development And Supply Of Life-Changing Medicines

Review the strategic application of extensive expertise in microbial systems to meet the increasing demand for novel biologics. Cutting-edge capabilities ensure streamlined processes.

European Center Of Excellence For Clinical Biologics

Explore how proven expertise and simplified execution with development, filling, and analytical under one roof ensure safe, efficacious products reach patients in need.

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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