Newsletter | September 10, 2026

09.10.26 -- The External Partners Delivering The Components Of RNA Therapies

SPONSOR

 

Webinar: Optimizing Peptide Production With PUREcoli™: A Smarter Microbial Approach To Therapeutic Peptide Manufacturing

Therapeutic peptide demand is surging, but traditional synthesis brings cost, scalability, and sustainability challenges. Explore how microbial expression using KBI Biopharma’s PUREplatform™ and PUREcoli™ technology can enable more efficient peptide manufacturing. Using liraglutide as a case study, discover practical strategies to improve yields, reduce costs, and streamline downstream processing for scalable, commercially ready production. Click here to learn more.

INDUSTRY INSIGHTS

 

Evaluating The Impact Of In-House Testing Strategies

Rapid analytical testing turnaround is essential to maintaining development timelines, meeting clinical milestones, and in commercial manufacturing, providing reliable drug supply to patients.

 

Building Late-Stage Efficiency Into Biologics Development

Building late-stage efficiency early in biologics development prevents scale-up delays. Flexible platforms and risk-based validation streamline technology transfer and lower production costs.

 

The Challenges Of Moving A Bioconjugate From Clinic To Market

Working with a partner that provides a one-stop shop for bioconjugate development and manufacturing helps prevent missteps that threaten the delivery of life-saving drugs to patients who need them.

FEATURED EDITORIAL

The External Partners Delivering The Components Of RNA Therapies

“RNA-based therapeutics” is now a diverse and wide field of application; outsourcing the components of these programs is challenging. Executives at the Society For RNA Therapeutics (SRT) say assembling an entire supply chain can soak up time and resources. Which partners to select depends on what area of RNA development you are pursuing. A fundamental task before all RNA sponsors is thinking deeply in terms of assembling development and manufacturing ecosystems, starting at the earliest stages of research and company formation.

 

Globalization vs. Localization: Where To Outsource In A Changing World

Geographical strategy for outsourcing is a pressing issue: balancing historical global supply chains with current pressures to reshore/nearshore parts of operations. In this fireside chat, editorial board members Lynn Cinelli, and Kent Pryor help us navigate the geographical pressures of modern outsourcing, the root causes of global supply chain breakdowns, the hardest assets to move across regions, and whether time-sensitive sponsors should simplify their chain or hunt for best-in-class partners globally.

INDUSTRY INSIGHTS CONTINUED

 

Strategic Approaches On The Path To GMP Manufacture

Tech transfer is a critical opportunity to establish a strategy for process performance qualification, mitigate late-stage obstacles, and streamline the pathway to clinical and commercial production.

 

Why Get Cleaning Validation Support From The Cleaner Supplier?

Standardize compliant cleaning by integrating risk-based validation, effective residue detection, and science-based limits to reduce cross-contamination and protect product quality.

 

Monoclonal Vs Polyclonal Antibody Production- Explained Step By Step

Selecting the optimal antibody framework is critical. Discover how monoclonal and polyclonal epitope specificity impacts manufacturing complexity, batch uniformity, and long-term therapeutic efficacy.

 

Nitrosamine Risk: Detection And Control

Bioprocess control relies on clear insight into cell health. Automated tracking cuts risk, saves time, boosts yield, and helps scale up fast to ensure smooth, top quality batch production runs daily.

 

Avoiding Launch Delays With A Proactive Tech Transfer Strategy

Commercial success comes from treating tech transfer as a strategic collaboration. Flexible processes, early supply chain planning, and partnerships protect timelines and drive long‑term performance.

 

Early-Phase Injectable Formulation Development

Discover how expert-driven strategies and data-centric tools can help you overcome formulation challenges and accelerate the development of stable, high-performance injectable therapeutics.

 

Maximizing Efficiency In mAb Manufacturing

Get access to the tools and expertise needed to support process development for biologic therapies from the clinical trial phase to commercialization.

 

The Hidden Challenges Of ADC Manufacturing - And How To Overcome Them

ADC manufacturing requires specialized expertise, single‑use systems, precise filtration, aseptic filling, and integrated lyophilization to ensure stability, safety, and consistent clinical‑grade production.

 

Strategic Early Material Generation For Accelerated Process Development

Learn how early material generation strategies can accelerate biologics development, streamline process optimization, and enable production-relevant material supply.

 

Lentiviral Vector Upstream Process

Lentiviral vector production is moving beyond adherent systems. Assimilate how streamlined workflows enable linear scale-up in stirred-tank bioreactors for cost-effective gene therapy manufacturing.

 

Applying Vaccine Expertise To Cell And Gene Therapy

Understanding these synergies and their impact on efficiency, safety, and cost-effectiveness is essential for stakeholders navigating the complexities of CGT development and production.

 

The Single-CDMO Advantage For Biologics

By forging strategic partnerships with comprehensive CDMOs, see how emerging biopharma firms can navigate through early-phase development and ensure a smooth transition to clinical advancement.

 

Development, Manufacture Of Biopharmaceuticals In Microbial Systems

We discuss the trends in new molecular formats, which is one of the current drivers of renewed interest in fermentation technologies, along with some of their challenges. 

SPONSOR

 

Outsourced Pharma Capabilities Update - ADCs

This digital event focuses on antibody-drug conjugates (ADCs) and how CDMOs support their development from early stages through clinical and commercial manufacturing. It highlights the importance of selecting the right partner for these complex therapies, including expertise in conjugation processes, scalability, regulatory needs, and integrated development services. Attendees will learn key criteria for evaluating CDMOs and how to align partnerships to accelerate ADC program success. Click here to learn more.

SOLUTIONS

Vaccine Development And Manufacturing

NYBCe CCS Apheresis Collection Sites And Capacity

Supporting Biologics Through Every Stage Of Growth

Annex 1 FAQs: Responding To The 2022 Revision

Delivering Reliable Sterile Manufacturing At Scale

From Vision To Vial

Accelerating Development With Integrated Analytical Services

Beyond Expectations

OUTSOURCED PHARMA CAPABILITIES UPDATE

Find Your New CDMO At Outsourced Pharma Capabilities Update

CDMOs in biologics, cell and gene, and small molecule share their capabilities and available capabilities. 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: