Outsourcing

Contract packaging organizations packaging biologic drugs for clinical trials use technologies that meet the unique requirements of each study.

Certain therapeutics, such as ophthalmics, must be provided as a sterile dosage form but can pose fill/finish challenges due to the small batch sizes required and the fact that the products used are difficult to fill and of high value.

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

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

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

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.