Manufacturing

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

Articles

Aseptic techniques must be practiced throughout all stages of biologics production.

Aseptic Processes Safeguard Biologics

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.

Optimizing the Manufacture of Emerging Therapies

Feliza Mirasol is the science editor for 

Avid Bioservices has launched new CGMP mammalian cell manufacturing suites at its Myford, Calif., facility.

Avid Bioservices Expands Mammalian Cell Capacity 

The BalanCD CHO media portfolio is designed to ensure maximized growth, viability, and productivity of CHO cell lines.

New Expansion for BalanCD CHO Media Platform Portfolio for Bioprocessing 

As new manufacturing processes and technologies are introduced to meet demand and overcome challenges, understanding also needs to improve to ensure the right balance is achieved.  

Balancing Change and Certainty in Manufacturing 

Samsung Biologics plans to invest more than ₩1.9 trillion (US$1.5 billion) in the new Incheon, South Korea, facility, which will hold a manufacturing capacity of 180,000 L.

Samsung Biologics to Build Plant 5 as Part of Capacity Expansion to Bio Campus II

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.

Manufacturing, Biologic Drugs