Manufacturing, Fill/Finish

Scenario modeling informs planning for current and future manufacturing needs.

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

Container and equipment innovations expand applications.

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.

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

A best practices approach to pharma’s most challenging-to-inspect container.

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.

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.

The guidance document provides recommendations for reporting and implementing changes to container closure system components consisting of glass vials and stoppers for sterile drug products.

While manufacturing increases have been implemented for vials and syringes, meeting future market needs remains unpredictable.

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 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.

Fill/finish inspection for vaccine vials and syringes must remain GMP-compliant while aiming for fast, efficient methods.

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.

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

Facility and equipment design are important, but the team and its experience matter most.