It is important to understand regulatory requirements and study challenges at the clinical stage.

Robust Bioanalytical Studies Can Aid in Regulatory Submissions

Automation of pharmaceutical packaging saves costs and time, say contract packagers.

Automating Packaging of Bio/Pharmaceuticals

When considering whether outsourcing to a CRO, one must consider the type of work, regulatory considerations, and study needs.

When to Outsource Bioanalysis Work to a CRO?

Topic

Chris Spivey is the editorial director of 

Podcasts

In this episode of the Drug Solutions Podcast, Chris Spivey interviews executives at Shabbas Solutions LLC, who ran the overseas QMM pilot project.

Drug Solutions Podcast: FDA Quality Management Maturity (QMM) Overseas Pilot Program Findings: Going Beyond the Regulations

Articles

Overall industry growth conceals growing numbers of smaller, faster-paced, adaptable corporate structures.

Shining a Light on Junior Pharmaceuticals

CellVax Therapeutics has selected Theragent, a new CDMO, to manufacture clinical trial material for a new Phase II prostate cancer immunotherapy drug candidate.

CellVax and Theragent Form Manufacturing Pact for Novel Cancer Immunotherapy Drug Candidate

Scorpion’s new facility is designed for the development and manufacturing of clinical and commercial-scale biologic drugs.

Scorpion Biological Services Opens San Antonio Biologics Facility

Lisete Pinto is Product Development and Technical Support senior manager at Recipharm.

In this article, the potential pitfalls of technology transfers are discussed as well as ways to ensure a smooth transition.

Addressing the Key Pitfalls Hindering Technology Transfer Success

Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.

Industry experts discuss best practices for certificates of analysis.

The Role of CoAs in Supplier Oversight

Steriline will be exhibiting its vial filling and capping machine (VFCM100) under double-wall isolator for aseptic filling at CPHI 2022 in Frankfurt, Germany, on Nov. 1–3, 2022.

Steriline Showcases Filling Equipment at CPHI 2022

The company is expanding its contract development and manufacturing services for parenteral drugs to global customers.

Terumo Pharmaceutical Solutions Expands CDMO Services

The CPHI Annual Report 2022 predicts cash reserves from venture capitalists and private equities will drive expansion in the demand for contract research organizations and contract development and research organizations.

Venture Capital Funding to Fuel Pharma Outsourcing

Under two new agreements, Societal CDMO will offer analytical, technical transfer, formulation, manufacturing, and packaging services for novel therapeutics.