Manufacturing, Biologic Drugs

MilliporeSigma’s new platform combines generative AI, machine learning, and computer-aided drug-design aimed at increasing the success rate of new drugs and therapies.

Digital transformation allows for smarter and connected biomanufacturing operations.

Novo Nordisk will invest more than DKK 16 billion (US$2.3 billion) to expand its production facilities in Chartres, France.

Lonza’s new GS Effex cell line can help overcome the challenges of developing therapeutic antibodies with increased potency.

The 3M Harvest RC Chromatographic Clarifier, BT500 is the latest addition to the company’s chromatographic clarifier portfolio.

Emergence of advanced manufacturing technology to ensure quality of biopharmaceutical drugs combined with efforts to identify a regulatory pathway indicate that a distributed manufacturing model is within reach.

SCHOTT now offers ViewCell, a new component meant to add flexibility to biopharmaceutical process control.

Dosage forms are being shaped by numerous factors, with patient-centricity continuing to be an important driver of decisions in development.

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

Samsung Biologics and Bristol Myers Squibb have further expanded their strategic manufacturing agreement to include the large-scale manufacture of an antibody cancer drug substance.

The agreement also lists that AGC Biologics will leverage the company’s monoclonal antibody development and manufacturing experience to perform process transfer, process optimization, and clinical manufacturing of the Asahi Kasei drug substance.

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.