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What Goes Into Restarting A Shelved Orphan Drug Candidate?

The Orphan Therapeutics Accelerator wants to help viable clinical-phase products reach patients. Its cofounder describes the complexity of rebooting a shelved candidate.

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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

July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing
Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.
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.
Combination Cell Therapy's Clinical Success Hinges On Manufacturability
Cell therapy could help unlock checkpoint inhibitors’ potential in solid tumors, but combination regimens raise the bar for manufacturing consistency and scalability.
Are Biopharma Companies Outsourcing Their Ability To Think?
Amid gaining immediate access to external manufacturing capabilities, sponsor companies can lose the foundational understanding required to govern that capability.
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.

BIOPROCESSING WHITE PAPERS

Producing MSC-Derived Cell Therapies From Isolation To Large-Scale Expansion
Explore the journey of producing MSC-derived cell therapies, from initial isolation and expansion to final product formulation and storage, and learn how to optimize each step.

The Complete Guide To Immunohistochemistry
9/24/2024

Immunohistochemistry (IHC) is a tool for visualizing the distribution and localization of antigens within tissue sections. Learn about IHC sample preparation, detection and amplification systems, and more.
Pushing The Boundaries Of Chromatographic Separation
7/29/2026

Metal-sensitive analytes often suffer from poor recovery and distorted peak shapes. Learn how inert hardware improves sensitivity and chromatographic performance for challenging analyses.
Tech Transfer At Risk: The Imperative For Digital Maturity, Modernization
12/2/2024

Tech transfer is critical for biopharmaceutical production, but outdated tools can hinder the process. Discover how digital maturity can streamline operations, reduce risks, and accelerate time to market.
Stabilizing Your Supply Chain In Times Of Global Volatility
6/12/2026

Discover how a proactive, risk-based supply chain strategy can help strengthen resilience, mitigate disruption, and ensure continuity across your biotech and pharmaceutical operations.
Super Short Activated CAR-T Process
1/17/2025

Experience the benefits of faster, more effective CAR-T cell production with this innovative three-day short-cycle process, designed to enhance patient treatment outcomes while reducing costs.

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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.