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

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

The much-anticipated meeting of FDA’s vaccine advisory committee this week is slated to address a number of critical issues related to testing and approval of vaccines to prevent COVID-19 infection.

Early Vaccine Authorization Raises Ethical and Logistical Challenges for Trial Sponsors

The unexplained illness in a study participant is being reviewed and evaluated by an independent data safety monitoring board and internal clinical and safety physicians. 

J&J Pauses COVID-19 Vaccine Candidate Clinical Trials Due to Unexplained Illness 

The company will supply its LIMS to the Walter Reed Army Institute of Research (WRAIR) to support vaccine production programs for COVID-19 at WRAIR’s pilot bioproduction facility.

LabVantage Awarded US Army Contract for LIMS COVID-19 Vaccine Support

Rentschler will handle the downstream processing to provide highly purified drug substance at its headquarters in Laupheim, Germany.

Rentschler to Partner with BioNTech for COVID-19 Vaccine Manufacturing 

The guidance provides recommendations for data and information needed to support an EUA for COVID-19 vaccines.

FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines

The study, entitled CV-NCOV-002, is being held in Peru and Panama and has enrolled 690 participants, including older adults ages 61 and above, and younger participants 18 to 60 years old.

First Participant Dosed in CureVac’s COVID-19 Vaccine Clinical Trial

Experts fear confusion over allocation process, cold-chain requirements, IT systems. 

COVID-19 Vaccine Distribution Raises Multiple Challenges

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

Misleading messages contribute to eroding trust in public health agencies

Vaccine Development and Manufacturing