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Why A Cell Therapy CEO Waited Until Phase III To Outsource

Sometimes, you have to go it alone. For a while, at least. The mantra across biotech has long been clear: engage your CDMO early, and let those experts guide you into manufacturing. Matthieu de Kalbermatten, CEO of CellProthera, a regenerative cell-therapy developer, begs to differ.

GUEST COLUMNISTS

March 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 Business Case For Continuous Manufacturing In Biologics
The question for leadership is not if continuous manufacturing will transform biologics, but when and how quickly to invest.
Mastering Biotech's Insourcing/Outsourcing Trade-Offs
Here's a case for the biotech hybrid model, one that relies on a crack team of internal core talent complemented by broad reliance on external vendors.
From Principles To Practice: Building Quality Into Generative AI-Assisted Pharma Operations
Learn what regulators are already asking about AI, what quality must mean in this new context, and how organizations can begin building the governance infrastructure.
Quantifying Single-Use Waste Produced During mAb Manufacture
Discover the current scale of plastic single-use technology waste and its projected growth, specifically for the biomanufacturing domain. There is an increasing need for sustainable solutions.
From QM To QMM For AI-Assisted Pharmaceutical Manufacturing Operations
The FDA’s focus has shifted from tracking quality metrics to promoting quality management maturity. AI/ML is poised to help with efforts, though it introduces additional complexity around data integrity.
The Systems And Choreography Needed For Grade B ATMP Material Transfer
Traditional material air locks often fail to account for the sheer throughput needed for cell therapy workflows. These design tips help prevent traffic jams.
Rethinking ATMP Assurance When Sterility Timelines, Reality Misalign
The compendial 14-day sterility testing window exposes product and patient to numerous risks, but settling on a rapid alternative also presents its own set of challenges.

PHARMA OUTSOURCING WHITE PAPERS

Building Local Biomanufacturing Capacity In South Africa
Biovac evolved from a vaccine supplier to a biopharmaceutical innovator, providing a blueprint for expanding Africa's vaccine manufacturing capacity. Gain valuable insights from their journey.

AAV-Based Gene Editing For Huntington's Disease
LETI-101 uses AAV5 to deliver a compact CRISPR system for allele-selective editing of mutant HTT, showing promise as a one-time treatment for Huntington’s disease with strong preclinical safety and efficacy.
Insights And Effective Strategies For A Successful Technology Transfer
Discover key strategies for seamless pharmaceutical technology transfers that accelerate time to market, ensure product quality, and meet regulatory standards across the drug lifecycle.
Biomanufacturing Readiness: A Validation Model For Multiproduct Facilities
Optimize your validation strategy to meet evolving regulatory demands and product complexities with a scalable, efficient framework that accelerates facility readiness and ensures consistent quality.
The Problem With Construction Quality
Data center construction quality management is inadequate, with issues traced to human error. A stronger focus on quality control and assurance is needed for success.
A Decade Of Transforming Pharmaceutical Manufacturing
Modern enzyme engineering, automation, and AI are reshaping therapeutic development — accelerating design, improving efficiency, and enabling faster, more sustainable biopharma manufacturing.