Newsletter | September 8, 2025

09.08.25 -- What FDA's Complete Response Letters (CRLs) Say About Outsourcing

SPONSOR

A long-standing partner engaged JHS to explore ways to reduce cycle times for a biologic drug, aiming to serve more patients more efficiently. The case underscores how long-term partnerships and collaborative problem-solving can unlock substantial productivity gains in pharmaceutical manufacturing. By combining process expertise, operational discipline, and shared commitment to patient outcomes, JHS and its partner developed sustainable improvements that expanded production capacity and improved delivery timelines.

INDUSTRY INSIGHTS

Proactive Strategies To Evaluate And Mitigate Clinical Supply Risk

Learn about approaches that can help build an understanding of risk assessment, in addition to how a study’s protocol requirements, packaging specifications, and more must be identified and addressed.

CHO Cell Lines For Recombinant Protein Production

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

Imaging Large Volume Subcutaneous Injections To Inform Clinical Design

New higher volume, higher viscosity pharmaceutical formulations for subcutaneous injection, alternatives to traditional intravenous treatment, enable chronic disease therapy in alternate settings.

FEATURED EDITORIAL

What FDA's Complete Response Letters (CRLs) Say About Outsourcing

Most readers know the FDA embraced "radical transparency” by publishing more than 200 complete response letters (CRLs) for drug and biologics applications submitted between 2020 and 2024. Hooray for the FDA; good for drug developers hard at work today. Good for developers, writes Chief Editor Louis Garguilo, because he can identify patterns to help us outsource better.

Essential Steps For A Successful Analytical Tech Transfer

Biologics tech transfer means sharing up to 20 assays. Miss a step, and you risk delays, bad data, and products stuck in limbo.

INDUSTRY INSIGHTS CONTINUED

Considerations For Tangential Flow Filtration Process Development

Optimize your TFF process with single-pass technology by hearing experts Mike Dango and Michael Brauchle share key strategies for scalable, efficient filtration process development.

Improving Efficiency In Contamination Identification

Learn how rapid microbial identification using MALDI-TOF improves contamination response, shortens investigation timelines, and enhances efficiency in biopharmaceutical manufacturing.

Analytical Strategies For Impurity Control In Antibody-Drug Conjugates

Antibody-drug conjugates (ADCs) combine antibody targeting with potent cytotoxic payloads to treat resistant cancers, but their complexity requires phase-appropriate analytical strategies.

Integrating Cutting-Edge Technologies In Cell Bank Manufacturing

Discover how an adoption of a counterflow centrifuge enhances GMP-compliant cell banking through closed-system automation, precision harvesting, and scalable workflows.

Accelerating Development With Rapid Delivery Of Toxicological Study Material

Explore key strategies and technologies designed to address the analytical considerations and material flows to facilitate the rapid delivery of toxicological material.

SPONSOR

Take a tour of Nanoform's best-in-class nanodevelopment capabilities, setting new standards in innovation. Their highly specialized team excels in creating unique nanoparticles for both small and large molecule APIs. With 14 development lines for small molecules and 5 for large molecules, Nanoform offers unmatched scalability and precision. Leveraging cutting-edge technology, they produce nanoformed materials as small as 10 nanometers. Learn more.

SOLUTIONS

Two Decades, One Focus: Sterile Manufacturing Excellence

Discover expert aseptic manufacturing with flexible batch sizes, regulatory excellence, and end-to-end support, specializing in sterile injectable solutions for clinical and commercial needs.

60 Years Of Providing Manufacturing Solutions To Patients

Explore why this company's partners trust them to produce safe, high-quality injectable pharmaceuticals, and where the team plans to head next.

A High-Capacity Chromatography Resin For Robust mAb Capture

Find a protein A chromatography resin with excellent capacity and alkaline stability for cost-efficient and extremely robust mAb capture.

Specialized Scientific Expertise In Biologics From Two Centers Of Excellence

This team of experienced scientists and regulatory experts provides tailored solutions for monoclonal antibodies, recombinant proteins, gene and cell therapies, vaccines, and other complex biologics.

Antibody Discovery And Engineering Services

Review a comprehensive suite of services for researchers seeking potent and functional antibodies. Find a variety of high-performance hybridoma- and display-based technologies.

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: