Facility Design and Engineering

The 65,000-square-foot facility is designed with the capacity and capability to help scale the next generation of CGTs for human trials and beyond.

The construction of Gritgen’s GMP facility strictly adheres to the global current GMP (CGMP) standards and complies with the regulatory guidelines of authoritative agencies including the National Medical Products Administration (NMPA), FDA, and the European Medicines Agency (EMA).

The steady rise in popularity of gene therapies and other biologics is the underlying reason for the growing importance of aseptic manufacturing processes in the biopharmaceutical industry.

With the two new GMP-grade mRNA manufacturing sites in Germany, MilliporeSigma can now offer fully integrated mRNA services.

The Novo Nordisk Foundation will invest up to DKK 950 million (€127 million, US$136 million) in a new cell therapy manufacturing facility in Lyngby, Denmark.

FUJIFILM Diosynth Biotechnologies has finished its new viral vector gene therapy manufacturing facility in Darlington, United Kingdom.

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses how to upgrade facilities in an efficient manner and other highlights from his presentation.

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses the definition of patient safety and how to implement new technologies into upgraded facilities.

Illumina’s new solutions center in Bengaluru, India, will expand access to genomics in the country.

Bristol Myers Squibb has joined Cellares’ Technology Adoption Partnership program just as Cellares launches operations as an integrated development and manufacturing organization.

The expanded operations will also support the start of proline/alanine/serine (PAS)-nomacopan clinical trials in geographic atrophy (GA).

The launch of Alpha Teknova’s new manufacturing facility in Hollister, Calif., increases its capacity for custom reagents for life sciences applications.

The new facility is set to utilize and extend SCG's capabilities in advanced cell therapy manufacturing and off-the-shelf human-induced Pluripotent Stem Cell (iPSC) technology.

MilliporeSigma has invested $25 million to expand its cell culture media production facility in Lenexa, Kan.

The goal for Upperton is to become fully operational by Q4 of 2023 for development and non-GMP manufacturing and a target start of GMP operations in January 2024.

German manufacturer metabion is conducting a multi-million euro expansion of its oligonucleotide manufacturing capacity in Munich East.

Tower Cold Chain will soon open its new headquarters in Philadelphia.

The new headquarters located in Columbus, Ohio, more than triples Andelyn Biosciences’ footprint to meet growing demand for CGT services.

India’s Enzene Biosciences is investing $50 Million into a new biopharma manufacturing plant in Hopewell, NJ.

The new facility also provides a plan for scalable product production processes that can potentially be replicated by Vaxxas domestically and globally.

The investment, which is taking place in Hillerød, Denmark, will aim to create more production capacity and increase the company’s ability to meet future market demands and to continue development on its future clinical late-phase product portfolio.

API supplier Olon has started construction of a new manufacturing facility in Milan, Italy, which will be dedicated to production of cytotoxic payloads and linkers for ADCs.

The new CGMP facility is expected to contribute to the development of mRNA therapeutics, with a building designed for the CGMP manufacture of mRNA-based in-vivo gene editing, gene-edited cell therapies, protein replacement therapies, cancer vaccines, and infectious disease vaccines.

The facility is based on a state-of-the-art design concept that allows maximum flexibility for a multi-product, multi-platform offering.

uBriGene Biosciences will acquire Mustang Bio’s Worcester, Mass., CGT manufacturing facility in a deal worth up to $11 million, expanding its operations into the US market.