Contract Manufacturing Services

ABEC Expands Equipment Supply Capability

August 28, 2018

The company is certified as a manufacturer of pressure vessels and components for use in China.

Emergent to Acquire Specialty Vaccines Company PaxVax

August 17, 2018

The acquisition is expected to support Emergent BioSolutions’ focus on public health threats and emerging infectious disease.

FDA Approves Drug Product Manufacturing for Samsung BioLogics

August 14, 2018

Drug product approval from FDA follows previous approvals from European and Japanese authorities.

Classifying Potent and Highly Potent Molecules

August 01, 2018

Determining how much containment is needed for API handling requires evaluation of multiple factors.

Designing Combination Products

August 01, 2018

API can be mixed with silicone and other polymers to create drug-delivery combination products.

CMO Roundup: Expansions for Biomanufacturing

August 01, 2018

CMOs have been active over the past year in expanding their biologics production and capabilities.

Small-Molecule Contract Services Update

August 01, 2018

This article provides a sampling of the latest investments, expansions, and acquisitions by small-molecule contract service providers.

What Ifs in the Five-Year Plan

August 01, 2018

Heightened uncertainty means CDMO executives need to play out planning scenarios.

Lifecycle-Based Process Validation Emphasizes the Need for Continued Process Verification

August 01, 2018

A year’s worth of FDA warning letters suggest that API and finished drug manufacturers should strengthen their approach to continued process verification.

How to Address Roadblocks During Technology Transfer: A CDMO’s Perspective

August 01, 2018

Real-life examples illustrate how to reduce the risks for each transferring partner and ensure that the development process meets regulatory requirements.