Manufacturing

Articles

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

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

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. 

Grand River Selected for Operation Warp Speed Efforts

Jennifer Markarian is manufacturing editor of BioPharm International.

Filling and packaging of primary containers is a crucial piece of COVID-19 vaccine production.

CDMOs Build Fill/Finish Capacity for COVID-19 Vaccines

James P. Agalloco is the president of Agalloco & Associates, P.O. Box 899, Belle Mead, NJ 08502, tel. 908.874.7558, jagalloco@aol.com. He is also a member of Pharmaceutical Technology’s editorial advisory board.

James E. Akers is the president of Akers Kennedy & Associates, PO Box 22562, Kansas City, MO 64113, akainckc@aol.com.

Technologies in use and on the horizon could change aseptic processing in ways that seemed inconceivable years ago but approaches to aseptic process validation still need to move beyond their 1970s roots.

Aseptic Processing Practices: Reviewing Three Decades of Change

Catalent has unveiled investment plans to create a European center of excellence for clinical biologics formulation development and drug product fill/finish services.

Catalent Invests Millions to Create European Clinical Manufacturing Center of Excellence

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

R+D Custom Automation Supplies Vial Machinery to SiO2 Materials Science

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

Robotic Inspection System Improves Accuracy

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

Vetter Expands Fill/Finish Capacity with Acquisition of New Site in Austria

The new facility in Grand Rapids, MI, is part of the CDMO’s aggressive expansion plan.

Grand River Aseptic Manufacturing Opens Large-Scale Injectable Fill/Finish Facility

Inovio received a $71-million contract from the US Department of Defense to scale up manufacture of its Cellectra smart device to deliver its DNA vaccine.

Inovio to Scale-Up Manufacture of Intradermal Delivery Device for its COVID-19 Vaccine

Corning will use BARDA funding to expand US manufacturing capacity for pharmaceutical tubing and vials made from Valor glass.

Corning Expands Glass Vial Capacity

SiO2 Materials Science has received $143 million from the US government to accelerate capacity scale-up of its advanced primary packaging platform. 

Manufacturing, Fill/Finish