Manufacturing

Vicky Qing XIA is Project Director at BioPlan Associates.

Articles

New study shows China biopharma companies face staffing shortages.

Staffing for China’s Rapidly Growing Biomanufacturing Industry

The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics

Critical Quality Attributes Challenge Biologics Development

Mark Quick is executive vice president of corporate development at Recipharm.

The industry is becoming more consolidated, but there needs to be some strategy behind the mergers and acquisitions.

Can Bigger be Better?

The Generic Pharmaceutical Association announces a rebranding campaign to expand access to medicines.

GPhA Rebrands as AAM

Sean Milmo is a freelance writer based in Essex, UK.

Early-access schemes aim to make medicines available to patients faster but the regulatory framework remains unclear especially for biologics that involve complex manufacturing.

Moving Forward with Adaptive Licensing

Randi Hernandez was science editor at Pharmaceutical Technology from September 2014 to May 2017.

Merck will pay a one-time fee of $625 million and additional royalties to BMS and Ono Pharmaceutical to settle the patent infringement case related to Keytruda.

Merck Settles Litigation with Bristol-Myers Squibb on Use of Antibody Targeting PD-1

In a blog post, Robert Califf and Rita Nalubola discuss the agency’s approach to the use of genome-edited products.

FDA Describes Its Approach to Genome-Edited Products

The agency plans on publishing more than 100 new or revised guidance documents in 2017.

FDA Releases 2017 Guidance Agenda

The partnership will focus on providing practical information to clients on the development of biologics and vaccines.

CSSi LifeSciences and BioMARC Partner to Accelerate Biologics Manufacture

Eric Langer has over 25 years experience in biotechnology and life sciences strategic marketing management, market research, and publishing. He has held senior management and marketing positions at biopharmaceutical supply companies. He has published and authored many books and reports on topics in Biotechnology, Large-scale BioManufacturing, and bioscience commercialization and communication. He teaches at Johns Hopkins University marketing management, biotech marketing, services marketing, and marketing in a regulated environment. In 1989 he co-founded BioPlan Associates, Inc. to provide market analysis, and strategy to biotech and healthcare organizations.

With a healthy supply of biosimilars heading to the approval pipeline, will license holders turn to contract manufacturers for development and production?

Manufacturing, Biologic Drugs