Manufacturing

Feliza Mirasol is the science editor for 

Articles

Sandoz, a Novartis division, is expected to invest at least $400 million to build a new biologics manufacturing facility in Lendava, Slovenia, to support growing demand for biosimilars.

Sandoz to Build New Biologics Production Facility in Slovenia

Under a technology licensing agreement with Bhami Research Laboratory, Catalent intends to develop formulations that will allow for the delivery of high-concentration biologics subcutaneously.

Catalent Licenses Bhami Research Laboratory Technology for Biologics Formulation Development

Shifts in pharmaceutical packaging have spurred tremendous growth in the pre-filled syringe fill/finish industry. 

Automated Inspection of Pre-filled Syringes and Biologics During Fill/Finish

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

Kai Lipinski, PhD, is the chief scientific officer of Vibalogics.

Although new single-use technologies offer the flexibility needed to overcome several challenges in ATMP production, there are many considerations and hurdles manufacturers must be aware of when scaling. 

Scaling Manufacturing Processes Using  Single-Use Technologies

Thermo Fisher Scientific’s new facility in Hangzhou, China, is designed to boost biologics and sterile development and manufacturing capabilities in the Asia-Pacific region.

Thermo Fisher Expands Biologics and Steriles Manufacturing Capabilities in China

Greg Swan is business development manager for Cell & Gene Therapy at Avantor.

Significant improvements have been developed to tackle the challenges in viral vector manufacturing at each stage.

Addressing Developmental Challenges of Gene Therapy Viral Vectors

Brian Mullan is the chief technical officer of Yposkesi, an SK Pharmteco company.

Whether biologic manufacturers decide to outsource or develop products internally, the quality of a CDMO partnership is critical to success, especially for cell and gene therapy products.

Choosing the Right CDMO for CGT Programs 

WuXi STA is opening a new large-scale oligonucleotide and peptide manufacturing facility.

Manufacturing, Biologic Drugs