Newsletter | July 3, 2025

07.03.25 -- Late-Stage Formulation Is A Different Ballgame. Insights From An Allstar

SPONSOR

20-minute capacity and capabilities quick-looks, 20+ brand new CDMO presenters to evaluate for best-fit this quarter – and a (virtual) commitment of less than 20 percent of your day? We're confident you don’t need 20/20 vision to see the value in this! Join us for Outsourced Pharma's July Partner Week – including sessions in Small Molecule API/HPAPI, Small Molecule Finished Dosage Form, ADC, Analytical Services, and Fill/Finish among others. Registration, on-demand access, and interactive Q&A are free.

INDUSTRY INSIGHTS

Analytical Techniques For Characterization, Release, And Stability Testing

Review the analytical considerations for subunit vaccines, vaccines that contain only the antigenic component(s) of a pathogen, and the assays needed.

Getting To The Heart Of CDMO Tech Transfer Excellence

Discover key factors that drive a seamless and efficient technology transfer, highlighting how a culture of technical expertise, customer focus, and operational flexibility is crucial to success in the CDMO industry.

Mammalian Or Microbial? Considerations When Choosing An Expression System

Explore how the right system can be tailored to meet the needs of each unique biologic. Whether trying to achieve speed and cost-effectiveness, higher yields, and glycosylation capabilities.

FEATURED EDITORIAL

Late-Stage Formulation Is A Different Ballgame. Insights From An Allstar

The art and science of late-stage/commercial formulation, compared to early-phase formulation, is a different ballgame, says Dileep Boinipally, currently utilizing CDMOs to advance a pipeline of oral and injectable candidates. He has a stadium full of advice for readers.

Understanding FDA's New National Priority Voucher Pilot Program

The FDA's vouchers will be issued to companies addressing health issues in the U.S. and increasing domestic manufacturing, among other criteria.

INDUSTRY INSIGHTS CONTINUED

Outsourcing Stability Storage: A Cost-Effective Approach

Learn why partnering with a leader in outsourced stability storage is revolutionizing the pharmaceutical and medical device industry by saving costs and resources, and ensuring product quality.

Quality By Design (QbD) For Biologics From A CDMO Perspective

Adopt principles in your biologics development and manufacturing process to ensure consistent product quality, mitigate risks, and align with patient safety and commercial success goals.

Introduction To Antibody Libraries For Display-Based Antibody Discovery

Witness how our capabilities in phage and yeast surface display can drive your next protein engineering or therapeutic antibody development project forward.

Overcoming Challenges In Combination Product Manufacturing

Blending pharmaceuticals and medical devices into a single product offers immense potential for patient care, but manufacturing these combination products presents unique hurdles.

Balancing The Scales: The Ups And Downs Of Bioprocess Scale-Up

Delve into the challenges of scaling in drug development through insights from both biopharma developers and a CDMO, and their shared goal of a successful scale-up.

Our Analytical And Quality Control Strategy For Your Therapies

A comprehensive Risk Analysis and Control Strategy is built on key pillars, each playing a vital role in ensuring that every final product meets the highest standards of safety and efficacy.

A Roadmap To Expedited Review Pathways

Accelerated timelines offer developers a pathway to rapidly bring new therapies to market while maintaining a balance of risk and benefit assessment. 

Optimizing Resupply To Reduce Risk Of Late Phase Delays

Early collaboration with a clinical supply manager can help proactively negotiate potential pitfalls. Observe efficient resupply practices and execute successful supply chain strategies.

Enabling Faster, Better Decisions In Early Stage Development

Microbial fermentation has experienced a renaissance in recent years. Examine the benefits of microbial fermentation for biologics production and improvements introduced to a microbial expression platform.

SOLUTIONS

Navigating Quality And Compliance In Biologic Testing

Biosafety testing ensures biologics' safety and quality but faces challenges like cost, time, and technical complexity. Proper planning and regulatory compliance are key to success.

Capacity Update April 2025: Large Molecule Development

Observe how world-class contract manufacturing expertise and global capabilities can help accelerate your biologic from development to commercial success.

Complex Chemistry For Antibody-Drug Conjugates And Beyond

With extensive experience, we deliver scalable, high-quality solutions tailored to challenging molecular constructs, ensuring efficiency and safety in the production of therapeutic modalities.

Capacity Update October 2024: ADC

We've expanded our U.S. and Germany sites to offer end-to-end services for product development, clinical and commercial fill/finish, and ADC conjugation and purification by 2025.

Integrated Biotech Services: From Strain To Commercial Product

Drawing on over 30 years of experience in biological processing, we offer our customers a comprehensive service package spanning all stages of development and production.

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.

Connect With Outsourced Pharma: