COVID-19 Update

Combatting Future Viral Threats with Vaccine Advances

The COVID-19 pandemic has led to many changes in how pharmaceutical companies develop vaccines.

What’s Next for COVID-19 Vaccines and Variants?

More technologies and treatments are emerging for COVID-19—along with new variants.

Key Elements for Assay Transfer Success

Partnerships formed during the COVID-19 pandemic have provided a platform for change in assay development and transfers.

CRB Completes Facility Construction for GRAM COVID-19 Vaccine Manufacturing

October 01, 2020

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.

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

September 28, 2020

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

September 28, 2020

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.

Novavax Begins Phase III Efficacy Trial of COVID-19 Vaccine

September 25, 2020

A clinical trial to enroll up to 10,000 volunteers across the UK will assess whether NVX-CoV2373 is effective in the prevention of COVID-19.

UK Prime Minister Visits Team Behind the Vaccines Manufacturing and Innovation Centre

September 24, 2020

UK's Prime Minister visited the site of the country’s VMIC in Oxfordshire, and met the teams working at the forefront of the national COVID-19 response.

Johnson & Johnson Launches Multi-Country Phase III Trial of Janssen’s COVID-19 Vaccine Candidate

September 23, 2020

A Phase III trial to evaluate safety and efficacy of Janssen’s COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S, is enrolling participants on three continents.

Thermo Fisher and Humanigen Partner for COVID-19 Therapeutic Candidate

September 23, 2020

Thermo Fisher will handle the technical transfer of the lenzilumab bulk drug substance process, with commercial scale production potentially beginning before the end of 2020.

Korean MFDS Approves Celltrion’s IND for Phase II/III Trial of COVID-19 Treatment

September 22, 2020

The Korean MFDS has given its approval for Celltrion to initiate a Phase II/III trial of its anti-COVID-19 monoclonal antibody treatment candidate, CT-P59.

COVID-19 Vaccine Concerns Prompt Clinical Trial Transparency

September 21, 2020

Fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.

Sanofi and GSK to Provide the EU with 300 Million Doses of its COVID-19 Vaccine Candidate

September 21, 2020

The companies will receive upfront funding from the European Union for the scale-up of manufacturing capabilities at industrial sites in Belgium, Italy, Germany, and France.