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

FEATURED EDITORIAL

Beyond API Sourcing: Avoiding Supply Disruptions For Small Molecule Drugs

Supply resilience should be assessed across the complete drug product pathway rather than measured by the number of vendors listed in a procurement system.

GUEST COLUMNISTS

Your 7 Decisions To Make Before MES Configuration
Don't wait until manufacturing execution system (MES) configuration to answer these 7 questions. Define your manufacturing process before digitizing it.
The Orange Book's Blind Spot: Process Stability And Capability
The current system for assuring therapeutic equivalence contains structural blind spots. Companies must evolve rather than merely adding corrective actions.
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.

PHARMA OUTSOURCING WHITE PAPERS

Bridging Studies For Producer Cell Line Adoption: Regulatory And Development Perspectives
Explore how analytical comparability, risk assessment, and bridging strategies can support a smooth and compliant platform transition.

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.
Designing, Selecting, And Developing Bioconjugates For Clinical Success
Accelerate the development of complex bioconjugates to unlock new possibilities for targeted therapies and advance the next generation of precision medicine.
How To Design And Evaluate Bispecific Antibodies (BsAbs)?
Bispecific antibodies combine two antigen-binding sites to enhance efficacy and safety. Their design requires structural strategy, MOA-based evaluation, and rigorous screening for optimal therapeutic performance.
Spray Dried Dispersions In Controlled Release Formulations
Integrating spray dried dispersions with CR strategies addresses poor drug solubility and the need for tailored release kinetics. Explore considerations to ensure stability and sustained supersaturation.
Where Innovation And Investment Reduce Drug Development Risk
How strategic investments in development, manufacturing, and clinical supply are helping organizations reduce risk and accelerate drug development.