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

FEATURED EDITORIAL

Trump's Big Pharma Deals Drive CDMO Investments

It is a remarkable twist of industry manipulations, government suasion, and economics. J&J cut a Most Favored Nation deal with the Trump administration that includes lowering prices – via TrumpRx.com – building more in the U.S., and (here’s the twist) investing in the U.S.-based facilities of a Japanese-owned CDMO. Got all that? Chief Editor Louis Garguilo offers analysis.

GUEST COLUMNISTS

Deploying A Vendor Life Cycle Oversight Model
A practical guide for adding oversight, based on a hierarchy of metrics, to quality agreements to transform them into living, metrics-driven control instruments.
Moving Leukopaks From GTP To GMP Is One Cell Therapy Trend To Watch In '26
Cell therapy stumbled in 2025. Solving the variability in starting material quality is critical to stabilizing manufacturing in 2026.
Metrics, Not Audits, Should Lead Vendor Accountability
Episodic vendor audits are better suited for high-risk areas. An oversight system, based on a hierarchy of metrics, provides greater value.
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.
2026 CDMO Forecast: The 7 Shifts Sponsors Need To Prepare For
2026 is shaping up to be a year in which operational discipline, strategic alignment, and regulatory preparedness will differentiate high-performing sponsors from those facing avoidable delays.
Biosimilar Manufacturing Complexity Demands Mastery, Not Mimicry
GlycoNex's denosumab biosimilar development experience illustrates how a "just copy it" approach is an insufficient strategy in modern biomanufacturing.
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.

PHARMA OUTSOURCING WHITE PAPERS

Accelerated API Manufacturing: Combining All Process Development Stages
During early-stage development, utilize the key considerations outlined in this paper to avoid common pitfalls and expedite the transition from molecule to market.

Tablet Manufacturing Technologies For Solid Drug Formulation
Compressed tablets are common oral solid dosages that contain the API and various excipients. Learn about the critical steps in selecting manufacturing methods and excipients to achieve the desired therapeutic effects and stability.
Compound Library Consortium
Explore how a novel approach to enhancing drug discovery efforts can significantly improve the chances of identifying promising drug candidates, ultimately accelerating the path from discovery to development.
The Role Of Extractables Data In The Adoption Of Single-Use Systems
Explore guidance for evaluating single-use systems for extractables and leachables, and learn how supplier-provided single-use system extractables data can save both time and resources.
Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars
The presence of ADAs can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.
Enabling Digital Twins With Computational Fluid Dynamics Modeling
Embrace the transformative power of predictive modeling and digital twin technology to optimize bioprocess efficiency, ensure product quality, and drive innovation in biopharmaceutical manufacturing.