Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

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The Case Of The Half Pill: AI As Outsourcing Detective

A number of patients report receiving half a pill in a blister pack of their prescribed medicine. The initial sponsor reaction is to place the problem at an external partner’s production or packaging line. But overall responsibility lies with the sponsor, and the true extent of the problem is hard to detect. Enter AI. Says Damiano Dragone, a long-term Quality expert, AI and biopharma professionals throughout the supply chain can join in a new “logic and creativity" to improve our industry on behalf of patients.

GUEST COLUMNISTS

Are You Falling Behind On Intelligent Pharmaceutical Manufacturing?
With a focus on small molecule drug product manufacture, let's take a closer look at the efficiencies gained through closed-loop control, PAT, digital twins, and more.
DEA Reveals Hidden Costs Of Analytical Validation Guidelines
By treating distinct validation guidelines as decision-making units, data envelopment analysis (DEA) allows for the mathematical evaluation of their resource efficiency.
Qualification And Validation Of Depyrogenation Tunnels And Autoclaves
Systemic vulnerabilities exist in thermal uniformity assurance, steam penetration verification, regulatory fragmentation, and tech harmonization.
FDA Modernizes Container Closure Guidance: What Is Changing And Why It Matters
The proposed revision reflects changes in packaging technology, drug delivery systems, quality risk management, and more that have occurred since 1999's guidance.
CDMO Selection Beyond Capabilities And Price
Some of the most useful information relevant to CDMO selection is also the hardest to obtain. Here are suggestions for uncovering data that tells the whole capability story.
August 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.
Building Sustainable Biopharma Supply Chains Starts With Procurement
Nearly all the industry's emissions happen upstream from core manufacturing functions. This puts sustainability almost entirely on the shoulders of purchasing.
US Pharma Reshoring: The Full Policy Timeline
As policy shifts and manufacturing investments reshape pharma supply chains, capacity constraints and global dependencies persist. Explore the implications for long-term resilience.

PHARMA OUTSOURCING WHITE PAPERS

The Strategic Value Of In-House Delumping For Homogeneous API Production
API batch homogeneity supports efficient manufacturing. Controlled delumping improves powder flow and chargeability while maintaining particle size integrity and reducing GMP-scale risks.

Streamlining Early Drug Development: Efficient Synthesis Of Highly Potent Compounds
Discover how risk‑based, phase‑appropriate synthesis enables safe, efficient production of highly potent compounds while balancing speed, worker safety, and regulatory readiness in early development.
Essential Strategies For Effective Viral Clearance Studies In Biologics Manufacturing
Strengthen your viral safety strategy by applying science- and risk-based approaches to viral clearance planning, ensuring robust data, regulatory compliance, and patient protection.
Best Practices For Regulatory Excellence In Clinical Research
Observe how GCLP can integrate ethical and technical standards to ensure reliable, compliant clinical trial data and optimize laboratory operations across sponsors, CROs, and partners.
Engineering Reliability In Cell Therapy Manufacturing
A cell therapy manufacturing model built on precision planning, digital execution, lifecycle‑ready CMC systems, and transparent collaboration to achieve high reliability and reduce variability across programs.
Control Strategies And Method Development For Nitrosamines In APIs And Drug Products
Explore regulatory insights, analytical strategies, and real-world case studies for effective nitrosamine control in APIs and drug products.