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In Bioprocessing, Trusted Data Is A Process Variable

As digital systems become increasingly interconnected, digital validation ensures systems generating and managing GxP data remain accurate, consistent, and trustworthy.

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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

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.
The Decision Rights Matrix: Making Sponsor-CDMO Governance Enforceable
In LVV manufacturing, the quality target product profile and the DRM are designed to work together. One defines what is being governed, the other names who governs it.
Defining Quality In A Sponsor-Owned QTPP Before The CDMO Even Starts
Version-controlled quality target product profiles, authored by the drug sponsor, close any gaps between the CDMO's and sponsor's definitions of quality.
Reshoring Pressure Meets Manufacturing Reality
U.S. pharma can't reshore what domestic capacity can't absorb. Senior leaders from Takeda, Biogen, Eli Lilly, and others reveal why tariff pressure is colliding with a sterile fill-finish shortage, workforce gaps, and ADC capacity bottlenecks.
CDMO Live Europe 2026: Partnerships For An Uncertain World
112 pages of executive insight from CDMO Live Europe 2026: tariffs, geopolitics, supply resilience, AI in manufacturing, and why strategic partnerships remain aspirational for most.
Resilience, Risk, And Relationships: CDMO Live Europe 2026 Report
Senior pharma leaders from Pfizer, Bayer, BioNTech and others debunk dual sourcing myths and reveal what separates strategic CDMO partnerships from transactional ones.
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.

BIOPROCESSING WHITE PAPERS

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.

Accelerate Lead Times Through Seamless External Collaboration In Quality
5/21/2026

As CDMO networks expand, disconnected quality processes create delays and risk. Learn how seamless external collaboration improves visibility, accelerates approvals, and strengthens sponsor–partner relationships—helping teams move faster without compromising compliance.
T Cells In Immunotherapies: The Key Progress Underway
6/1/2026

CAR-T therapies now make up 73% of active pipeline programs, yet solid tumors remain largely out of reach. Where is T cell immunotherapy headed next, and what does it mean for your pipeline strategy?
Criteria For Effective Bioprocess Scale-Up
3/25/2026

Discover four essential bioprocess scale-up criteria and how each balances hydrodynamics, shear, and mass transfer across manufacturing scales.
Biocapacitance Measurement: A PAT Tool For Biomass Measurement In An Upstream Process
3/20/2026

Leverage process analytical technologies (PAT) to gain real-time insight into product quality, strengthen control strategies, and build more efficient, scalable manufacturing processes for future success.
Handle Single-Use Technology Biopharma Waste: Data Sharing, Collaboration
7/7/2025

Learn more about data sharing and collaboration to enable a better environmental impact of single-use technologies (SUTs) and quantifying the single-use plastic waste generated when manufacturing mAbs.

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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.