Manufacturing

Articles

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.

FDA Publishes Guidance on Changes to COVID-19 Container Closure Systems

Feliza Mirasol is the science editor for 

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

Increases in Manufacturing Capacity Target Vial and Syringe Shortages

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

Meeting Fill/Finish Challenges for COVID-19 Vaccines

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

Cytiva Acquires Vanrx Pharmasystems

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

Piramal Pharma Solutions to Provide Sterile Fill/Finish Support to Theratechnologies

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. 

Moderna and Recipharm Announce COVID-19 Vaccine Supply Agreement 

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.

Thermo Fisher Scientific Expands Sterile Drug Product Development and Commercial Manufacturing

Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.

A holistic approach to validation and quality assurance is essential.

Prepping Fill/Finish Systems to Ensure Quality Output 

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.

Baxter to Invest $50 Million into Indiana Fill/Finish Manufacturing Facilities Expansion

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.

Vibalogics Establishes US Presence with Boston Virotherapy Manufacturing Facility

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.

Thermo Fisher Scientific to Develop Two Sterile Filling Lines at New Facility in Singapore

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

Reconfiguring Fill/Finish Inspection to Meet COVID-19 Vaccine Goals

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.

CRB Completes Facility Construction for GRAM COVID-19 Vaccine Manufacturing

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.

Novavax and Par Sterile Products Enter into Fill/Finish Manufacturing and Services Agreement for COVID-19 Vaccine Candidate

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. 

GRAM Partners with Johnson & Johnson for Fill/Finish of Vaccine Candidate

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

Catalent Acquires New Biologics Facility in Indiana 

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

AMRI Signs Agreement with AstraZeneca for COVID-19 Vaccine Delivery

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

Strategizing for Rapid Changeovers in Biologics Manufacturing

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

Samsung Biologics Expands Manufacturing Facilities and Launches Cell Line Technology

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

Manufacturing, Fill/Finish