Outsourcing

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

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.

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

Intensified and distributed manufacturing approaches create flexible, local capacity.

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

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 will manufacture CvnCoV at its facility in Germany.

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.

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

A digital system makes real-time inventory, production, distribution, and shipping information readily accessible.

The rapid and efficient delivery of innovative treatments through the COVID-19 pandemic has demonstrated the value of collaborations within the bio/pharma industry.

The COVID-19 pandemic is pushing more companies to adopt just-in-time practices, but success demands careful upfront risk assessment and planning.

More work is needed to ensure the rising demand for cell and gene therapy manufacturing capacity and required skilled workforce can be met in Europe.

The acquisition strategically expands SPT Labtech’s offering in sample management for life sciences.

The second phase of the Myford facility expansion in California will add upstream and downstream processing suites.

The deal expands Wavelength’s drug substance manufacturing footprint and its API CDMO business.

Cascade began production on new facilities to manufacture APIs for clinical and commercial GMP production.

The companies have expanded their existing partnership to include 40 Million Doses of COVID-19 vaccine for South Korea.

The acquisition will integrate drug substance, drug product, and clinical testing capabilities under Quotient.

The CGMP manufacturing agreement will expand production of lenzilumab, a candidate for COVID-19 therapy, to support a potential emergency use authorization filing.

PathoQuest will apply its experience in viral safety testing and quality control of biologics for mitigating the risk of adventitious agent contamination in biopharmaceutical manufacturing.

Accelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.

Having a clear and detailed understanding of exactly what a biomolecule entails is essential for therapeutics development.

Outsourcing partners can provide a multitude of advantages in the development of drug delivery solutions, including those designed for targeted patient populations.

Collaboration between equipment suppliers and users is leading to innovation and optimization in biopharmaceutical manufacturing.