Outsourcing

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

Pending a completed FDA inspection, Emergent BioSolutions halts manufacture of vaccine drug substance at Maryland 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.

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.

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

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 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.

CDMOs address the unique challenges of liquid and lyophilized forms as well as preparing for the large capacity needed for COVID-19 vaccines.

Nexelis’ recent acquisition of GSK’s Marburg, Germany-based vaccines clinical bioanalytical laboratory expands its bioanalytical capabilities.

The £500,000 (US$686,294)-investment in mass spectrometry support will accelerate biologics development and approval.

Best practices can help ensure supply chain flexibility and viability for biologic drugs in clinical trials.

A strategic separation is designed to enhance the value and growth of Paraxel’s contract research services and Calyx’s imaging businesses.

Vendors are finding ways to address the increasingly complex analytical challenges in the biopharmaceutical industry to further biotherapeutic development.

After a hectic 2020, biopharma looks to deliver on COVID-19 vaccines and move other promising therapies forward.

Outsourcing increases as the industry balances development and manufacturing of both COVID-19 treatments and non-pandemic-related medicines.

Evonik offers lipid nanoparticles for gene-based drug development and manufacturing.

The company is investing in expansion at four sites in the United States, United Kingdom, and Italy, which will include construction of new facilities and addition of sterile and lyophilized filling lines.

Cytiva is adding process development, media and assay development, and contract development services at its facilities in Korea, Japan, Sweden, and the UK.

CDMOs strive for flexible, adaptable processes and fast tech transfer for manufacturing investigational drug products, including COVID-19 treatments and vaccines

The new super plant, being built in Incheon, South Korea, will have a total biopharmaceutical manufacturing capacity of 256,000 L.

The companies have formed a long-term manufacturing agreement to accelerate the global supply for Lilly’s COVID-19 antibody therapeutics.

The partners have established PathoQuest, Inc., a US subsidiary, and will construct an NGS-based testing lab at Charles River’s Wayne, PA, site.

Apiject was approved for a $590-million loan from the US to build in-country capacity for COVID-19 vaccines and therapeutics.

Analysis from the CPhI Annual Report has revealed that the global contract services sector is benefitting from a switch toward COVID-19 manufacturing and clinical-stage contracts; however, mega-cap pharma innovation is slowing outsourcing.