Manufacturing, Parenterals and Injectables

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.

Material properties play a role in container closure integrity under frozen or cryogenic storage temperatures.

Under the terms of the expanded agreement, Catalent will provide Moderna with a new high-speed vial filling line until June 2023 along with inspection, labeling, cartoning, and final packaging for potential pipeline programs.

Intensified and distributed manufacturing approaches create flexible, local capacity.

Although vials and prefilled syringes have different advantages, both find use in vaccine fill/finish.

The expanded agreement will include aseptic fill/finish services at its San Diego, CA facility.

Manufacturing of the vaccine will take place at Baxter’s fill/finish sterile manufacturing facilities located in Bloomington, IN.

CDMOs address the unique challenges of liquid and lyophilized forms as well as preparing for the large capacity needed for COVID-19 vaccines.

Cytiva acquired Vanrx Pharmasystems, a Canadian manufacturer of robotic aseptic filling equipment.

Clinical material for a Theratechnologies product in development will be produced at PPS’ manufacturing facility in Lexington, KY.

The site, which is set to be operational in three years, will feature disposable technology and advanced technology filling lines to produce 90 million vials and 50 million pre-filled syringes a year.

The companies have entered into an agreement to support the formulation and fill/finish of Moderna’s COVID-19 vaccine supply outside of the United States.

The product represents a first-of-its-kind intentional genomic alteration in a line of domestic pigs that may be used for human therapeutics.

The company is investing in expansion at four sites in the United States, United Kingdom, and Italy, which will include construction of new facilities and addition of sterile and lyophilized filling lines.

The investment will expand and upgrade manufacturing capacity and technology for pre-fillable syringes and will also includes a new manufacturing facility in Europe.

Gerresheimer now offers its Gx RTF syringes with SG ITC (Integrated Tip Cap) twist-off closure from Stevanato Group.

A holistic approach to validation and quality assurance is essential.

The expansion will include a new 25,000-ft2 warehouse, a filling line for flexible plastic containers, a high-speed automated syringe fill line with the ability to fill up to 600 units per minute, and a high-speed automated visual inspection line.

The 110,000 ft2 site, which is set to be operational by the second half of 2021, will feature new technology including 2000-L scale bioreactors and additional fill-finish capabilities.

An optimal engineering design is crucial for aseptic operation and cleaning.