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Ask The Pros — The Latest In Upstream HCP Mitigation

We asked leading experts how upstream interventions can reshape HCP control. Here’s what they shared. Answers have been edited for clarity.

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EDITOR'S DESK

Supporting The Next Generation Of ADCs
Experts discuss innovation in antibody-drug conjugate (ADC) technology and how these impact CMC strategy. This summary captures key takeaways from the Bioprocess Online Live event "Evolving CMC Strategies To Enable Next-Gen ADCs."

The 9 Fastest-Growing Outsourcing Segments

Capacity isn’t the choke point—capability is; this piece ranks nine fast-growing outsourcing segments and shows sponsors how to win by locking in modality-proven partners early.

AbbVie And Amgen's Blueprint To Digitalize Biomanufacturing

At BioProcess International 2025, leaders from AbbVie and Amgen gave keynote presentations about how their companies are advancing product development through digital tools.

On The Ground At BPI: Kat Kozyrytska On Ethical AI And Collaboration

AI consultant Kat Kozyrytska advocates for ethical AI adoption and explains its potential to foster collaboration across the industry.

On The Ground At BPI: Takeda's Amy Shaw On Scaling Cell Therapy Manufacturing

Takeda head of process development, Amy Shaw, explains what factors to consider when scaling up or scaling out cell therapy manufacturing.

GUEST COLUMNISTS

A Deeper Look At Pharma's Structural Supply Chain Vulnerability
Fixing limited capacity in pharmaceutical CMC development starts with understanding a complex web of root causes.
Survey: SUS Insufficient For 40% Of Biopharma
New data from BioPlan Associates suggests single-use systems adoption may be plateauing with single-digit growth rates.
Allogeneic Cell Therapy's Success Hinges On Perfecting The Platform
The industry remains far from realizing a manufacturing platform with a repeatable, standardized process that can support broad clinical and commercial deployment.
CGT Industrialization Starts With CDMO Alignment
Fragmented processes are stalling progress. By aligning CDMOs through transparency and standards, developers can move past the COGS obsession and stabilize the supply chain.
Reimagining HACCP And Other Process Flow Risk Analysis Methods Using Relational Risk Analysis
Combining relational risk analysis (ReRA) modeling strategies with hazard analysis and critical control point (HACCP) and other process flow risk analysis methods makes them more efficient.
November 2025 — 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.
Contamination Control Strategies In Low Bioburden Biologic Drug Substance Manufacturing
How do manufacturers apply a contamination control strategy in a non-sterile world, particularly at a low bioburden biologic drug substance manufacturing site? How can Annex 1 apply?
What 2025 FDA Warning Letters Tell Us About GMP Compliance
This analysis identifies key compliance trends and regional disparities by examining the 2025 U.S. FDA warning letters issued to drug product manufacturers posted between Jan. 1 and Dec. 9, 2025.

BIOPROCESSING WHITE PAPERS

Quality Assurance In IVT RNA Vaccine Development Using Electrophoresis
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.

Navigating The Complexities Of Pre-Filled Syringe Manufacturing
9/4/2025

Drawing on our extensive expertise in sterile injectables (SI), here, we highlight practical strategies and proven solutions designed to help navigate challenges and support the reliable, scalable production of high-quality PFS therapies for patients worldwide.
Bio-Based Polymers Towards Net Zero In Single-Use Bioprocessing
6/13/2025

Decarbonizing healthcare and pharmaceuticals is vital to meet climate goals and safeguard public health. Learn why these energy-intensive sectors must act swiftly to reduce emissions and navigate complex global supply chains.
Analytical Techniques For Characterization, Release, And Stability Testing
4/28/2025

Review the analytical considerations for subunit vaccines, vaccines that contain only the antigenic component(s) of a pathogen, and more specifically the assays needed.
The Benefits Of Incorporating Lean Methodologies Into Project Management
8/20/2024

Delve into the core principles of lean project management and explore how these principles can be integrated with traditional methods to enhance project outcomes.
Bioconjugates – An Increasing Diversity, A Blossoming Of Therapeutic Applications
10/24/2024

Harness the power of bioconjugation to revolutionize targeted therapies, enhance drug efficacy, and reduce side effects, paving the way for more precise and effective treatments across a range of diseases.

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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.