Fill-Finish

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.

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.

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 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 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.

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.

The CountQ system from Verista automates accurate counts of tray-loaded parts, including vaccine vials.

The facility will include a high-speed sterile line for live virus filling, a line for standard fill/finish, cleanroom capacity, labs, warehousing, and offices to support production.

The 60,000-ft2 facility was built using CRB’s ONEsolution project delivery method and was designed to expand GRAM’s large-scale fill/finish capacity.

Par Sterile will produce the vaccine for use in Novavax's Phase III clinical trial in the United States, while also providing fill/finish services for commercial distribution in the US.

GRAM is expanding fill/finish capacity and is working with Janssen on tech transfer in preparation for production of Janssen’s SARS-CoV-2 vaccine candidate at GRAM’s Grand Rapids, MI facility.

The facility for early-phase clinical biologics formulation development and drug product fill/finish services will be integrated with an existing Catalent facility nearby.

The new line has the ability to aseptically fill powder, liquid, suspension, and combination forms into vials in clinical or commercial batch sizes.

AMRI will provide AstraZeneca with manufacturing capacity and sterile fill/finish services at its drug product manufacturing facility in Albuquerque, NM.

The company has made several moves in recent weeks to expand manufacturing capacity and cell line services.

The CDMO will offer capacity for manufacturing and distributing COVID-19 vaccines and therapeutics at its Grand Rapids, MI, fill/finish facility.

Outsourcing partners provide capacity and tech transfer expertise in the pharmaceutical industry response to the COVID-19 pandemic.

Stevanato Group and Colanar have signed an agreement for lab scale fill/finish capabilities to study container closure systems at Stevanato Group’s US TEC in Boston, MA.

The agreement will accelerate production of SiO2’s plastic vials for vaccines and therapeutics for Operation Warp Speed.

Stevanato Group’s Vision Robot Unit uses AI-based machine learning capabilities for particle and cosmetic inspection of biopharmaceutical drug products.

The acquisition will give the CDMO additional clinical filling options in Europe, which is expected to come online in 2021.