Newsletter | August 11, 2026

08.11.26 -- June 2026 — CDMO Opportunities And Threats Report

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Cell Bank Manufacturing

Your master cell bank (MCB) is critical to therapeutic product development, in addition to supporting clinical development, manufacturing, and commercial supply of biologics. Put your bank in the hands of the experts and get it right the first time.

FOCUS ON OUTSOURCING

6 CMC Strategies Are Transforming Biologics Drug Development

Sid Jain's two decades across Novartis, Regeneron, and Sanofi reveal six CMC strategies redefining how biologics reach the clinic, from CDMO selection to digital transformation pitfalls.

June 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.

A Strategic Enabler For Scaling Gene Therapies

Platform-based manufacturing uses standardized, pre-qualified workflows and analytics that reduce variability, simplify regulatory submissions, and accelerate the path to commercial success.

BIOSECURE, Tariffs, And The New CDMO Reality For Biopharma Innovators

Secure domestic or diversified biopharma manufacturing to protect therapeutic development from supply chain disruptions, rising costs, and legislative tariff impacts.

Setting A New Benchmark for Sustainability In Contract Manufacturing

Operational excellence meets ethical stewardship. Data-driven strategies and renewable energy integration are shaping a responsible future for global manufacturing and community engagement.

Supply Chain Resilience In Multi-Continent Biopharma Manufacturing

Multi-continent manufacturing networks minimize supply chain risk. Relying on site alignment, robust tech transfer, and unified quality standards ensures a flexible and resilient supply chain.

How Reshoring, GLP-1s, And Supply Chain Security Are Transforming CDMOs

Explore how reshoring, GLP-1 capacity demands, and integrated U.S.-based manufacturing models are reshaping CDMO partnerships in a rapidly evolving pharmaceutical market.

Building Scalable Non-Viral Gene-Edited Cell Therapy Processes

Rahul Purohit, Ph.D., discusses the challenges and opportunities of scaling non-viral gene-edited cell therapies, with practical guidance for balancing performance, cell quality, and manufacturing readiness.

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.

Precision Polymorph Screening With Electron Diffraction

See how polymorph screening with electron diffraction uncovers hidden forms, enabling precise identification and reliable quantification of minor phases affecting performance and manufacturability.

Viral Safety Testing In Biologics: Detecting What Current Methods Miss

Biologics face unpredictable risks as complexity grows; evolving testing strategies to broaden detection, address gaps, and strengthen safety confidence without disrupting development or compliance.

LYO Cycle Development Ensures Success For Oncology Drug Scale-Up

An optimized lyophilization cycle removes excess moisture during scale‑up by adjusting drying for larger equipment, improving stability, maintaining efficiency, and supporting clinical validation.

How Efficiently Can We Take An Nbe From Gene To IND?

Discover streamlined gene-to-IND development for early-stage NBE programs, delivering Phase I readiness through integrated services, rapid scale-up, transparent pricing, and coordinated execution.

3 Keys To Success When Planning With Your CMO Partner

Once you've identified a CMO partner, how do you ensure success? The secret: planning as early as possible – while your product is still in preclinical or clinical development.

OUTSOURCING SOLUTIONS

Peptones, Hydrolysates, And Yeast Extracts - Nu-Tek Biosciences

Capabilities Update June 2026: Cell Therapy - ElevateBio

Path To First-In-Human - Thermo Fisher Scientific

Putting More Within Reach - BD Medical - Pharmaceutical Systems

Capabilities Update June 2026: ADC - Samsung Biologics

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