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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.

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EDITOR'S DESK

BIO 2026: Crowley On Competing With China And Modernizing The FDA
Exclusive coverage from John Crowley's press conference at the 2026 BIO International Convention in San Diego.

Essential CMC Elements For A Therapeutic Secretome

Noveome Biotherapeutics's Larry Brown, Sc.D., explains the regulatory and CMC challenges behind the company's novel secretome therapy, ST266.

Midyear Pulse Check: What's Shaping Biopharma In 2026?

This article summarizes the major developments and industry pressures highlighted by Life Science Connect editors in the "Better Biopharma" midyear editorial roundtable.

Reflecting On Continued Turbulence At The FDA

Bioprocess Online's Editorial Advisory Board responds to former FDA commissioner Marty Makary’s resignation amid a prolonged period of instability at the agency.

Insufficient Vendor Data Is Hamstringing Single-Use Adoption

Audience polls and expert insights reveal insufficient vendor data as the main bottleneck stalling advanced single-use technology adoption. Explore that and other key takeaways in this recap of the Bioprocess Online Live event on "Closing The Adoption Gap For Advanced Single-Use Materials."

GUEST COLUMNISTS

Demonstrating Non-Inferiority Of BFPCs Vs. Traditional Air Monitoring
Demonstrating non-inferiority of bio-fluorescent particle counter (BFPC) technology to traditional active air-sampling methods is essential for implementation. Here's how to approach it.
The Missing Layer: Why CAR-T Needs AI As Its Connective Tissue
AI can close CAR-T’s access gap by replacing fragmented community delivery handoffs with automated orchestration across referral, reimbursement, logistics, and monitoring.
Building A Self-Driving Lab For LNP Development
With commercially available components, MIT researchers built a platform that accelerates LNP process development, optimization, and autonomous manufacturing research.
Exploring Takeda's Template For Sustainable Steam Generation
Takeda designed a model for delivering steam at 11 bar and up to 184 degrees using natural refrigerant and waste heat at one of its largest production sites.
Addressing The Particulate Challenge In Cell Therapy Products
Cell therapy products challenge traditional particulate controls. One expert explains detection, mitigation, and contamination prevention.
Let's Stop Treating Allogeneic Cell Therapy As One Thing
Industry is beginning to accept that allogeneic cell therapy spans categories, and success depends on aligning biology, regulation, and economics unique to each product.
Allogeneic Cell Therapy Is Still Learning What Biology Will Allow
Allogeneic cell therapy is advancing through smarter donor selection and manufacturing control, showing how biology, process design, and product consistency drive success.
Top 5 Challenges In Antibody-Oligonucleotide Manufacturing
AOC manufacturing breaks programs in five predictable ways. Learn where antibody-oligonucleotide conjugate development stalls, from synthesis impurities to conjugation chemistry, and what preparation actually looks like.

BIOPROCESSING WHITE PAPERS

End-To-End Process Scalability Of HEK 293 Media For High Titer AAV Production
Explore how controlled bioreactor environments enable optimization of critical process parameters and support robust, scalable AAV production from development through manufacturing.

Rapid Discovery And Characterization Of Monoclonal Antibodies Against The SARS-CoV-2 Delta Spike Protein
4/23/2025

Delve into the intricate workflow employed for the discovery and characterization of monoclonal antibodies (mAbs) targeting the Delta spike protein.
The Future Of Cleaning Validation
7/23/2025

Explore evolving cleaning validation strategies in life sciences, from regulatory foundations to digital innovations, and discover how agile, risk-based approaches can enhance compliance and efficiency.
Optimize DNA Clearance In High-Salt, GMP-Grade Purification Processes
9/16/2025

Efficient hcDNA removal is vital for therapeutic safety and compliance. Discover how salt-active enzymes support high-salt purification workflows to help manufacturers meet strict regulatory standards.
Why Pharmaceutical Scientists Trust The Discovery Core Rheometer
5/1/2026

Drug formulations demand more than single‑point viscosity data. Explore how rheology reveals stability, flow, and structural behavior across suspensions, topicals, and injectables.
Context-First Data For Trustworthy AI In Biopharma
6/26/2026

Bridge the gap between AI experimentation and enterprise value. Learn how capturing structured, semantically rich data at the point of origin builds regulator-credible AI pipelines.

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BIOPROCESSING APP NOTES & CASE STUDIES

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BIOPROCESS ONLINE CONTENT COLLECTIONS

This collection of articles digs into the industry’s growing focus on knowledge management as an indispensable facet of biomanufacturing and pharmaceutical development, exploring how it plays into risk management, quality, vendor relationships, and supply chain resilience.