Outsourcing

Developing a Method for Success

): Outsourcing method development offers multiple benefits to companies.

Packaging Biologic Drugs for Clinical Trials

Biologic drugs used in clinical trials need technologies to meet the unique requirements of each study.

Eyeing Up Success in Fill/Finish

Certain high-value sterile dosage forms pose fill/finish challenges due to the small batch sizes

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.

Stelis Concludes Fundraise Worth $195 Million

March 25, 2021

Stelis Biopharma has closed its Series B and Series C fundraise for US $195 million, which will be used to progress the company’s growth initiatives and help scale its business.

Expediting IND Submission

March 18, 2021

An integrated CMC provider can help smaller companies to streamline development timelines and reduce project management complexity when compared with multi-provider models.