Newsletter | May 26, 2026

05.26.26 -- April 2026 — CDMO Opportunities And Threats Report

SPONSOR

Webinar: Advancing Next Gen Antibodies and ADCs: From AI Driven Cell Line Development to Integrated Manufacturing

Explore how AI-driven cell line development and integrated CMC strategies are transforming next-generation ADC manufacturing. This Cytiva webinar covers faster clone selection, improved productivity, scale-up considerations, and future-ready bioprocessing approaches for complex antibody therapeutics. Gain insights into emerging technologies that support consistency, accelerate timelines, and strengthen commercialization readiness across evolving antibody-based therapies. Click here to learn more.

FOCUS ON OUTSOURCING

April 2026 — CDMO Opportunities And Threats Report

Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

Improving Viral Vector Production Through Addressing Complexity

Watch as our CGT experts explore the evolving landscape of viral vector manufacturing, overcoming production bottlenecks, and the strategies necessary to bring life-changing therapies to more patients.

De-Risking FDA Abbreviated New Drug Application (ANDA) Submissions

This disposable pen for Semaglutide is a generic drug-device combination, designed for usability and regulatory compliance, showing comparable performance to the reference device.

Improving Safety And Efficacy With Charged Variant Characterization

Discover how a CDMO with extensive experience in protein variant characterization, CQA analytics, and patient-centric product development can ensure the safety and efficacy of your biotherapeutic.

The Future Of Allogeneic Cell Therapy: Hypoimmunogenic Donor Cells

Take a look at how gene editing and HLA-F technologies are revolutionizing hypoimmunogenic cell development for scalable allogeneic therapies.

Why Developability Assessments Matter

Developability assessments flag early risks in stability, manufacturability, and biophysics, helping teams focus on candidates most likely to succeed clinically and commercially.

Avoiding Common Real-World Pitfalls In Viral Clearance Studies

Viral clearance studies face regulatory uncertainty, process limits, timeline pressure, and design challenges, demanding phase‑appropriate, flexible strategies for reliable outcomes.

Using Tech Transfer To Accelerate NDA Approval

A biotech company accelerated NDA approval for a novel anti‑infective by executing a highly disciplined, first‑time‑right technology transfer and registration batch manufacturing strategy.

Building A Path To A Successful AAV Product

See state‑of‑the‑art analytical methods for AAV characterization, key quality attributes to monitor, and approaches for measuring infectivity and full‑to‑empty capsid ratios.

Trends Shaping The Future Of Cell And Gene Therapy Manufacturing

Gain insight into how automation and digitalization are transforming cell and gene therapy with scalable, decentralized manufacturing and smarter market navigation.

Increasing Batch Size And Reducing Cycle Times For A Biologic

JHS partnered with a global pharma company to optimize biologic production, increasing output by 50% and reducing batch release times by up to 30%.

Accelerating Gene Therapy Development For NEDAMSS

Find out how one family's race against time led to the creation of a groundbreaking gene therapy for their daughter, just 14 months after her ultra-rare disease diagnosis.

Unlock Robust And Reliable Stability Data With The Right Partner

Stability testing is essential to ensuring your drug’s stability, potency, efficacy, and safety under different controlled conditions throughout development, manufacturing, and life cycle management.

OUTSOURCING SOLUTIONS

Production Site Brno (CZ) Clinical/Commercial Syringe Line - medac CDMO

Capabilities Update March 2026: Large Molecule - FUJIFILM Biotechnologies

Aseptic Manufacturing: Fill/Finish For Vials, Syringes, Cartridges - Grand River Aseptic Manufacturing

Your U.S.- Based Bioconjugation Partner - LOTTE Biologics

From Lab Through Launch - Simtra BioPharma Solutions

Our Biotech Success — Surrozen - Lonza

Connect With Bioprocess Online: