Manufacturing, Biologic Drugs

Chime Biologics, Leads Biolabs, and BeiGene have formed a three-way collaboration to advance the development and global manufacturing of Leads Biolabs’ lead mAb candidate, LBL-007.

Syngene has acquired a multi-modal biologics drug substance manufacturing facility in Bangalore, India, from Stelis Biopharma.

A novel complement therapeutic CTx001 offers a novel approach to treating geographic atrophy.

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

Mendus and NorthX Biologics will work to develop and commercialize Mendus’ lead asset, vididencel, an allogeneic dendritic cell vaccine.

Charles River’s off-the-shelf lentiviral vector packaging plasmids are intended for use with cell and gene therapies.

WuXi Biologics is expanding its manufacturing capacity for drug substance and drug product at its sites in Leverkusen and Wuppertal, Germany.

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

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.

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

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

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.

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.

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.

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.

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

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.

To prepare for emerging mRNA technologies, it is necessary to adapt fill/finish and cold chain capabilities.

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.

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.

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

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.

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

Demand spurs innovations in syringes and syringe fill/finish operations.

MilliporeSigma and Lotte Group will collaborate on facility design and workforce training for a new biologics business unit in the US.