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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.

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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

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.
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.

BIOPROCESSING WHITE PAPERS

A Toolbox For An Effective Tech Transfer
As drug development costs rise, companies are embracing digital-first strategies and Pharma 4.0 principles to streamline operations, enhance tech transfer, and accelerate time-to-market through innovation.

Quality Assurance In IVT RNA Vaccine Development Using Electrophoresis
2/20/2025

Discover advanced solutions for IVT RNA synthesis, focusing on enhancing fidelity in throughput, innovative technologies, and methodologies to optimize your RNA research and development processes.
Non-Viral Genetic Modification Using The 4D-Nucleofector LV Unit In CGT
11/21/2024

This paper underscores the 4D-Nucleofector® LV Unit as a pivotal tool for translating genetic modification technologies into scalable, safe, and effective therapeutic solutions.
Overcoming Challenges To High-Concentration Formulation Development
3/25/2025

Explore how the S-HiCon™ platform optimizes high-concentration therapeutic antibody formulations, overcoming stability and manufacturability challenges to deliver safe, effective therapies.
Optimizing Safety Measures For rAAV Therapies
10/11/2024

Explore common process-related impurities found in recombinant Adeno-Associated Virus (rAAV) vectors and the analytical testing methods used for these residuals.
Random And Semi-Targeted Integration In Cell Line Development
8/5/2025

While semi-targeted approaches may offer precision, uncover how they may fall short in overall efficiency and productivity, especially in late-stage manufacturing.

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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.