Manufacturing

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

Articles

The complexity of the pharmaceutical product brings challenges to the transfer of information and technology between sponsors and contractors.

Communication is Key in Complex Tech Transfer

Doris Rottenbusch is the team manager for technology and process transfer at Vetter Pharma Fertigung GmbH & Co KG.

Adherence to detail and thorough project management are required for successful tech transfer and scale up.

Scale-up and Tech Transfer: From Development Lab Studies to Commercial Production

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

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

Societal CDMO Signs Multiple CDMO Service Agreements

In a goal to boost local pharmaceutical production, the World Health Organization has established a global manufacturing training hub in the Republic of Korea through which Bangladesh, Indonesia, Pakistan, Serbia, and Vietnam will receive mRNA technology.

WHO Establishes Global Biomanufacturing Training Hub in Republic of Korea

Luc Gagnon, PhD, is vice-president of Vaccine Sciences at Nexelis.

Partnerships formed during the COVID-19 pandemic have provided a platform for change in assay development and transfers that should continue in the future.

The Key Elements for Assay Transfer Success

H.S. Pordal (harbinder.pordal@stress.com) is principal of Stress Engineering Services, Inc., 7030 Stress Engineering Way, Mason, OH 45040; (513) 336-6741.

Clint A. Haynes is vice-president of Stress Engineering Services, Inc., 7030 Stress Engineering Way, Mason OH 45040, (513)336-6741.

Sachin Kurian is analyst with Stress Engineering Services, Inc., 7030 Stress Engineering Way, Mason OH 45040, (513)336-6741.

Model-based approaches and digital analytics are improving flexibility at both the equipment and the manufacturing-line level. 

Will Advanced Technology Redefine Bio/Pharma's Agility?

Allison Cacciatore, Facilities Design and Engineering, Pharmatech Associates

For drug sponsors that are considering building their own manufacturing facilities, an expert project team is crucial.

Best Practices for Designing and Building a Pharmaceutical Manufacturing Facility

Honeywell’s project team has remotely and efficiently migrated Richter Gedeon’s process control system with limited onsite staffing and resources.

Honeywell Completes Remote Control System Migration for Hungarian Pharma Manufacturer

AbCellera’s recent acquisition of the OrthoMab bispecific platform is expected to accelerate antibody product development.