Manufacturing, Parenterals and Injectables

Moderna and Thermo Fisher Scientific have formed a collaboration to leverage dedicated commercial fill/finish manufacturing capacity in the US for mRNA vaccines and therapies.

Eli Lilly and Company is investing $1 billion to establish a new manufacturing site in Concord, NC, to manufacture parenteral products and devices.

Fareva plans to use blow-fill-seal equipment and ApiJect’s prefilled injector technology to create fill/finish capacity in France.

Isolators move into smaller-volume processes, including cell and gene therapy manufacturing.

New equipment meets needs for faster vial labeling and RFID for unit-level serialization.

Trends and technologies in pharmaceutical manufacturing were highlighted on the show floor and in the conference sessions on the INTERPHEX Innovation Stage.

Baxter will invest $100 million in new lyophilization equipment and an additional aseptic syringe filling line at its Halle/Westfalen (Germany) location.

Global CDMO, ten23 health, has acquired filling technology and drug product manufacturing expert, swissfillon, enhancing its integrated offering.

In this collaboration, Takeda will utilize Poseida's biodegradable DNA and RNA nanoparticle delivery technology and other proprietary genetic engineering platforms for the research and development of gene therapies.

Conventional and robotic automation inside closed systems reduces risk.

Alternative materials, as well as supply-chain planning, are essential to ensure a reliable supply for parenteral drug packaging.

Lonza plans to establish drug product manufacturing capabilities at is site in Guangzhou, China, to produce clinical trial and commercial supply in the country.

Terumo Blood and Cell Technologies and PhotonPharma announced a collaboration to develop a novel tumor-specific immunotherapy for solid tumors.

Glenmark Pharmaceuticals has partnered with SaNOtize to manufacture, market, and distribute NONS to India, Singapore, Malaysia, Hong Kong, and more.

GSK announced that FDA has approved a new indication for Nucala (mepolizumab), a monoclonal antibody that targets interleukin-5.

In combination with etoposide and either carboplatin or cisplatin, Imfinzi has been approved in the first-line setting of ES-SCLC by China’s National Medical Products Administration.

The new lab near Continuus Pharmaceutical’s current facilities in Massachusetts will expand the company’s process development capabilities to high-potency drugs.

Recipharm has signed a memorandum of understanding (MOU) with His Majesty the King of Morocco, the Moroccan government, and a consortium of leading banks from the country, for fill/finish capacity in the country.

Container and equipment innovations expand applications.

Amgen’s greenfield facility near Columbus, Ohio to assemble and package vials and syringes is expected to be operational by 2024.

Automation offers benefits for sterile manufacturing in 503B outsourcing facilities.

The new line can fill prefilled syringes, cartridges, and vials using ready-to-use components.

Samsung Biologics plans to support the production of hundreds of millions of doses of Moderna’s vaccine to supply to markets outside of the United States beginning in the third quarter of 2021.

Advances in automation and cleanroom technology improve efficiency for small commercial quantities of aseptically filled drug products.

Certain therapeutics, such as ophthalmics, must be provided as a sterile dosage form but can pose fill/finish challenges due to the small batch sizes required and the fact that the products used are difficult to fill and of high value.

BioNTech plans to expand its global footprint by establishing its regional headquarters for southeast Asia and a new mRNA manufacturing facility in Singapore.

The semi-automated TipFil Syringe Filler from TurboFil Packaging Machines provides accurate and consistent fills.

Complex formulations, personalized medicines, COVID-19 therapies, and sustainability goals are driving innovations in drug packaging.

Moderna’s investments will double the formulation fill/finish and drug substance manufacturing of its vaccine to up to three billion doses in 2022 at various manufacturing sites.

Sanofi will perform the fill/finish of up to 200 million doses of Moderna’s COVID-19 vaccine at its Ridgefield, NJ, facility starting in September 2021.