Outsourcing

Just in Time for Clinical Trials

Risk assessment and careful planning are crucial for timely delivery

Demonstrating the Value of Collaboration

The rapid pace of drug development during the COVID-19 pandemic demonstrates the value of collaborations.

Collaboration Takes Cell and Gene Therapies Closer to Their Full Potential. Image: warut - Stock.adobe.com

Collaboration toward Commercialization

Innovators, contractors, and technology providers advance cell and gene therapies.

Beyond Lyophilization

May 03, 2021

Breakthroughs in analytics and alternatives to traditional freeze drying promise to reshape biological development and the cold chain.

Evolving Analytical Technology Unravels Protein Characteristics

May 02, 2021

Mass spectrometry and automation are growing in importance for protein characterization, but further improvements are still needed.

CPhI Post-Pandemic Survey Suggests Drive for Repatriation of Manufacturing

April 23, 2021

Executives that participated in the CPhI post-pandemic survey are predicting a push for repatriation of manufacturing globally.

Emergent BioSolutions Hit with FDA Form 483

April 21, 2021

Post-inspection report reveals nine sanitary and process problems at Bayview, Md., facility.

FDA Inspectors Cited Critical Problems at Emergent Facility

April 09, 2021

Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.

J&J to Take Over Its Product Manufacturing at Emergent Facility

April 05, 2021

Following a manufacturing mix-up, J&J will extend its oversight at Emergent’s Maryland facility; AstraZeneca manufacturing to relocate.

Advanced Manufacturing Technologies Shift Outside the Box

April 03, 2021

Intensified and distributed manufacturing approaches create flexible, local capacity.

Supply Chain Challenges Creating Hurdles to COVID-19 Vaccine Production

April 02, 2021

The availability of materials is a critical factor when it comes to vaccine capacity.

SGS Facilitates Phase I Study of ImmTOR in Gene Therapy

March 30, 2021

SGS is supporting Selecta Biosciences and Asklepios BioPharmaceutical with the Phase I dose-escalation trial of SEL-3999, an AAV8 vector capsid containing no transgene with ImmTOR.

Celonic Group to Manufacture CureVac’s mRNA COVID Vaccine Candidate

March 30, 2021

Celonic will manufacture CvnCoV at its facility in Germany.