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

FEATURED EDITORIAL

Cargo shipping container with EU European Union flag-GettyImages-1476198848

2025 Tariffs Barely Impact Europe's API Supply Chains

When earlier this year the Trump administration began waving the specter of tariffs on drug substances and products entering the U.S., the biopharma world held its breath. European countries, as much as even China, felt the lack of oxygen. Would, for example, global sponsors leave European CDMOs to relocate their API production at contractors in the U.S.? Here's what we uncovered.

GUEST COLUMNISTS

The Future Of Biotech Outsourcing: Essential Skills For Program Managers
The next generation of program managers who liaise with contract manufacturers needs an expanded skillset to thrive.
Hidden Sensitive Data Liability: Why Legacy Web Forms Put Life Sciences Organizations At Critical Risk
Many life science organizations collect sensitive data through outdated web forms, exposing companies to critical vulnerabilities, data breaches, regulatory penalties, and more.
A Hierarchy Of Metrics Brings Strategy Into Biopharma's Daily Work
Information now flows faster than organizations can think about it, and without deliberate structure, decision-making becomes reactive rather than reflective.
An End-To-End Automated HTP Platform For Cell Line Optimization
Bristol Myers Squibb's high-throughput stable CHO platform produces high-titer, high-quality material in a fraction of the conventional timeline.
FDA Draft Guidance On CES Signals More Reliance On Toxicity And PK
The technology to measure alternative metrics is vastly improved. Now, FDA joins other regulators in deprioritizing comparative efficacy studies for biosimilars.
Maximizing The Value Of An Internal Audit Program In Pharmaceutical Quality Operations
A shrinking FDA and rising supply pressures demand stronger risk management and smarter internal audits. Here’s how pharma can truly “see things as they really are.”
AI Is Not The CMC Revolution You're Looking For, And That's OK
Advanced therapy development today is less about big funding, more about frugality. Artificial intelligence unlocks a competitive advantage.
Phages As A Pharmaceutical: New EMA Guidance On Antimicrobial Drug Development
The EMA has now issued a draft guidance on quality aspects of phage therapy medicinal products. Rising antimicrobial resistance has renewed interest in bacteriophages to fight pathogens.

PHARMA OUTSOURCING WHITE PAPERS

5 Steps To Design A Microbiological Performance Qualification For Facilities Explore five steps to design an EMPQ for sterile manufacturing: classification, protocol drafting, cleaning evaluation, disinfectant efficacy testing, and continuous improvement.

Next-Generation CRISPR Approaches
By providing essential components like nucleases, gRNAs, and HDR templates, a reliable CDMO facilitates a seamless transition from discovery research to clinical trials and beyond.
How Lipid Nanoparticles Enable Next-Gen Delivery
Cell therapy’s future depends on smarter gene delivery. Learn how lipid nanoparticles offer a scalable, cell-friendly alternative to electroporation and viral vectors for manufacturing efficiency.
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.
Achieve Higher Targeted Concentrations
Single-pass TFF streamlines downstream processing by reducing footprint, shear exposure, and hold-up volumes. Learn how this approach is advancing efficiency across therapeutic and vaccine production.
Advancing Drug Development With Optimized LC-MS/MS Bioanalysis
Explore the critical role of sample preparation optimization and the application of liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS) in bioanalytical method development.