Newsletter | August 28, 2025

08.28.25 -- Lilly's Kinsale Facility Provides A Benchmark For Your CDMO Selection

INDUSTRY INSIGHTS

Expanding Clinical Trials Internationally In The ATMP Space

Discover how the global expansion of ATMP trials offers significant advantages but demands early, strategic planning to overcome complex international challenges.

Flow Chemistry vs. Batch Processes

Explore how continuous flow chemistry can accelerate your chemical development with greater efficiency, safety, and sustainability compared to traditional batch processes.

Getting To The Heart Of CDMO Tech Transfer Excellence

Review five 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.

FEATURED EDITORIAL

The Building Blocks Of A Robust Analytical Assay

Analytical assays aren't just important for quality control. Regulators expect them. These tips will help if you're just starting to build your analytical package.

Lilly's Kinsale Facility Provides A Benchmark For Your CDMO Selection

Consider these two questions: How do we select a CDMO? How do we select a facility? The second of these should carry as much weight as the first, but unfortunately often does not. Chief Editor Louis Garguilo thinks that should change. He turns to Eli Lilly's ISPE Award Winning facility, and Lorraine O'Shea, Associate Vice President and Plant Manager at Lilly Kinsale, to make the case.

INDUSTRY INSIGHTS CONTINUED

The AOC Puzzle: Strategies For Chemistry, Manufacturing, Regulatory Success

Gain valuable insights from industry experts on overcoming the unique chemical, technical, and regulatory challenges of antibody-oligonucleotide conjugates (AOC) development.

Enhancing Sterility: The Crucial Role Of Isolators In Sterile Fill/Finish

Isolators provide a controlled and sterile environment during manufacturing. A CDMO that prioritizes quality, sterility, and compliance can help you deliver the highest level of quality and sterility.

ADC Market Perspectives And How Innovations Are Improving Therapies

Hear experts discuss the latest trends in antibody-drug conjugate (ADC) discovery and development and how next-generation pipelines are being shaped by payload and linker-chemistry innovations.

Why Embrace Diversity, Equity, And Inclusion In The CDMO/Biopharma Sector?

Recognizing and integrating diversity, equity, and inclusion (DEI) is essential for fostering innovation, improving team performance, and ensuring long-term competitiveness in a global market.

Forced Degradation Of Biopharmaceuticals: Protein Stress Testing

Start your forced degradation studies early to uncover molecular risks, strengthen product stability, and ensure regulatory-ready development from the start.

Microbial Tech Transfer: Tips To Consider When Selecting A CDMO

Choose a flexible and experienced CDMO to ensure seamless scalability, diverse process capabilities, and expert analytical support for your microbial protein production.

Optimizing TFF And SPTFF For High-Concentration mAb Formulations

Discover the critical role of formulation buffer composition in stabilizing mAbs during tangential flow filtration, a process involving ultrafiltration and diafiltration under high pressure and shear forces.

Cell Line Development For Multi-Chain Biologics

Explore the application of a platform in creating CHO cell lines, emphasizing the uniformity of the pools generated by this platform in terms of titer and the rapid selection of these pools.

SOLUTIONS

Glass Prefillable Syringe Solution Delivering Complex Biologics

BD Neopak™ XtraFlow™ Glass Prefillable Syringe solution leverages 8 mm needle length in combination with thin wall cannula to reduce pressure drop and enhance flow.

Drug Product Development Of Poorly Soluble Compounds

Eurofins CDMO Alphora offers comprehensive drug product development and manufacturing, specializing in poorly soluble compounds, clinical manufacturing, and integrated solutions.

Wide-Ranging Expertise And Vertically Integrated Service

Northway Biotech has the ability to rapidly execute multiple projects from its state-of-the-art cGMP facilities while ensuring full process and product compliance at all stages.

Two Decades, One Focus: Sterile Manufacturing Excellence

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

Tools For Developing Successful Biologics

The XS® Pichia Expression System allows you to develop scalable, robust, and reliable processes to express your biologics drugs with improved productivity.

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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