Outsourcing

AGC Biologics has partnered with BioNTech to further supply plasmid DNA starting material from its Heidelberg, Germany, facility for the Pfizer-BioNTech COVID-19 vaccine.

The increased number of regulatory filings for cell and gene therapies requires reevaluation of bioassay methods because of their complexity.

Outsourcing method development offers multiple benefits to companies, including access to experience and expertise, streamlined costs, and development time efficiencies.

The expected growth of the global bio/pharmaceutical market is pushing for the continued evolution of the CDMO arena.

As the RNA therapeutic market grows, contract manufacturing services for GMP-grade RNA are in demand and expected to continue on an upward trajectory.

Assessing biosafety using NGS-based tests requires a continuum of skills in molecular biology, biocomputing, virology, and quality systems.

The COVID-19 pandemic has triggered additional considerations to supplier oversight of contract manufacturing facilities.

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

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

Packaging materials, kit design, and cold-chain handling should be optimized for each study.

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.