FDA cites Emergent for failings at plant that contaminated J&J doses

A recent nine-day inspection by agency officials found numerous breaches of manufacturing standards and inadequate training for factory employees. 

By Ned Pagliarulo • April 22, 2021

J&J to oversee vaccine production at Emergent factory that ruined doses

The change, which follows the contractor's costly manufacturing mix-up, will displace production of AstraZeneca's unauthorized shot at the Baltimore site.

By Ned Pagliarulo • April 5, 2021

Manufacturing mix-up could blunt supply boost from J&J vaccine

One vaccine batch being manufactured for J&J by Emergent Biosolutions failed quality checks, reportedly ruining material sufficient for up to 15 million doses. 

By Ned Pagliarulo • April 1, 2021

How to navigate Health Canada XML PM requirements

Learn the latest about XML PM mandates and timelines from structured labeling experts.

March 22, 2021

Paving the way towards the biomanufacturing facility of the future

Technologies that enable bioprocessing 4.0 are creating the roadmap to the facility of the future.

By Merrilee Whitney, Head of the BioContinuum™ platform • March 15, 2021

Vaccine factories churn out millions more doses, speeding US rollout of coronavirus shots

The U.S. is now averaging more than 2 million doses given each day, a pace that will help President Joe Biden meet his target of 100 million shots in 100 days well ahead of schedule. 

By Ned Pagliarulo • March 11, 2021

Merck to help J&J make vaccine doses in White House-brokered deal

The U.S. government will give Merck $269 million to help the drugmaker retool two of its facilities to make J&J's one-dose shot. 

By Jonathan Gardner • Updated March 2, 2021

Moderna, Pfizer ready multi-pronged plans for coronavirus variants

Moderna has delivered a modified version of its vaccine to NIH scientists, while Pfizer has begun testing of an additional booster shot in a clinical trial, both precautionary steps against emerging strains.

By Jonathan Gardner , Ben Fidler • Updated Feb. 25, 2021

Pfizer set to double weekly production of coronavirus vaccine

The drugmaker will use production lines at its plant in McPherson, Kansas to help fill vaccine vials, company CEO Albert Bourla said Friday.

By Ned Pagliarulo • Feb. 19, 2021

US secures 200 million more vaccine doses from Pfizer, Moderna

With the orders now finalized, President Biden said the U.S. would have enough doses to vaccinate 300 million Americans by the end of the July.

By Ned Pagliarulo • Feb. 12, 2021

Moderna planning to add doses to coronavirus vaccine vials

The biotech aims to add five more vaccine doses to each vial — currently labeled to hold 10 each — but needs to secure FDA sign-off on the change.

By Ben Fidler • Feb. 2, 2021

Bayer agrees to help CureVac produce coronavirus vaccine

Already a partner on the shot's development, Bayer will chip in on manufacturing too, pledging to make 160 million doses in 2022.

By Ned Pagliarulo • Feb. 1, 2021

Novartis joins Sanofi in aiding manufacture of coronavirus vaccines

A deal to fill vials of Pfizer and BioNTech's vaccine could be the first of several Novartis signs to help others make COVID-19 treatments.  

By Ben Fidler • Jan. 29, 2021

US to order 200M more doses of Pfizer, Moderna coronavirus vaccines

As coronavirus variants spread, the White House aims to up U.S. vaccine supply by exercising purchase options in contracts with Pfizer and Moderna.

By Kristin Jensen • Jan. 27, 2021

COVID-19 study builds at pandemic speed

How to accelerate time-to-market, gain greater control of study data and execution, and optimize the entire trial lifecycle.

Jan. 25, 2021

Surface plasmon resonance in biopharmaceutical industry: Real-time and label-free characterization

Surface Plasmon Resonance (SPR) is a robust, but complex analytical tool that provides paramount value to the development and understanding biopharmaceutical products. 

By Dr. Sasmit S. Deshmukh and Dr. Alex Perieteanu • Jan. 4, 2021

Altasciences' comprehensive, integrated solution for clinical supply manufacture

Integrated CRO/CDMO solutions for accelerated and more efficient early drug development programs.

Dec. 7, 2020

Vaccine production in focus as Moderna, Pfizer await FDA decision

Moncef Slaoui, a leader of Operation Warp Speed, said he expects 100 million Americans to be vaccinated by the end of February — an ambitious target even as Moderna and Pfizer ramp up manufacturing.

By Ned Pagliarulo • Dec. 4, 2020

US buys another 650,000 doses of Lilly's COVID-19 drug as outbreak surges

The U.S. government has ramped up spending on Lilly's and Regeneron's antibody-based COVID-19 treatments, but each remain in short supply.

By Kristin Jensen • Dec. 3, 2020

Cell therapy commercialization: How to achieve positive customer experience

What are the critical needs your commercial model must address to deliver a best-in-class experience?

By Curt Kugel, Sankalp Sethi and Meghan McDonald • Dec. 3, 2020

CDC panel recommends giving first coronavirus vaccines to healthcare workers, nursing home residents

Advisers on the CDC panel cited risk and disease burden as reasons for setting their priority list for the first vaccine doses to become available, supply of which will be extremely limited.

By Jonathan Gardner • Dec. 1, 2020

Bluebird faces delay for sickle cell gene therapy as rivals inch closer

The setback for Bluebird's LentiGlobin comes amid a string of manufacturing-related delays for gene therapy developers.

By Kristin Jensen • Nov. 5, 2020

Chinese biotech partnered with GSK gets funding boost for coronavirus vaccine

Clover Biopharmaceuticals, one of several China-based groups advancing a coronavirus shot, has now received one of the largest investments to date from the vaccine development alliance group CEPI.

By Kristin Jensen • Nov. 3, 2020

Axovant shares sink on manufacturing delay for Parkinson's gene therapy

A longer-than-expected timeline for developing a new manufacturing process means a key study for Axovant's top gene therapy likely won't begin until 2022.

By Ned Pagliarulo • Oct. 30, 2020

Novartis, Molecular Partners partner to develop a scalable COVID-19 drug

The two Swiss firms will develop protein drugs that are meant to have similar effects as coronavirus antibodies, but would be easier to mass produce.

By Ben Fidler • Oct. 28, 2020