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

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

Articles

In addition to a new interim president, the company is opening new microbial capacity at its San Antonio facility and has plans to construct a commercial-scale facility in Manhattan, Kan.

Scorpius BioManufacturing Announces New Microbial Capacity and New Interim President

Actylis new 30,000-ft² API manufacturing facility is located in Eugene, Ore.

Actylis Opens 30,000-square-foot API Manufacturing Facility

Editor of Pharmaceutical Technology Europe

Podcasts

In this episode, Rhonda Henry and Adam Mendizabal from Emmes discuss the role CROs play in cell and gene therapies undergoing clinical trials at all stages.

Drug Solutions Podcast: How CROs Adapt Themselves in the Ever-Changing Landscape of Cell and Gene Therapies

The trends shaping the growth of the biologics outsourcing industry demand attention.

The Logistics of Outsourcing Biologics

The bio/pharma outsourcing industry continues to be integral in the development and manufacture of medicines. 

Outsourcing Still Vital

Quotient Sciences’ facility expansion is designed to increase support for fully integrated drug development programs.

Quotient Sciences Expands Formulation Development Capabilities at Nottingham Facility

is an executive director at WuXi Biologics.

Wesley Wang is vice-president at WuXi Biologics.

Weichang Zhou is president at WuXi Biologics.

In this paper, the authors lay out some commonly accepted HCP analytical methods, the challenges of HCP assay, and provide recommendations on what can easily be accomplished in-house and when it may be better to outsource.

Current Trends in Host Cell Protein Detection for Biologics Manufacturing

Jeong Jin-hyeok is a lead specialist in drug product at Samsung Biologics.

To prepare for emerging mRNA technologies, it is necessary to adapt fill/finish and cold chain capabilities.

Preparing for a New Wave of mRNA Technologies

Shifting toward more technological solutions and ensuring a greater understanding of the workforce’s needs will give both CROs and sponsors a market advantage.

CROs Gaining a Competitive Edge

Growth in outsourcing has been the result of COVID-19 projects taking 
precedence, which has pushed some contract manufacturing to second-tier CDMOs. 