There is a great need for sensitive, precise, and easily accessible analytical detection techniques for protein sequencing.

Biologics Quality Control: The Growing Need for Accessible Proteomics

The emergence of mRNA vaccines and cell and gene therapies has pushed innovation in analytical methods.

Emerging Therapies Drive Analytical Advancements

Effective analytics will eliminate failures, deviations, and non-conformances.

 Analyzing Exabytes

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Articles

Abzena has entered into a Master Services Agreement with a US biotech company to provide process development and manufacturing services to progress a novel antibody-drug conjugate (ADC) to clinical trials.

Abzena Secures ADC Manufacturing Contract with US Biotech Firm

The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a “follow-on” product. 

FDA Approves Sanofi’s Follow-On Insulin

In partnership with Indian pharmaceutical firm, Torrent Pharmaceuticals, Novo Nordisk has expanded an insulin manufacturing facility at Torrent’s Indrad, Gujarat, India site.

Novo Nordisk Expands Insulin Manufacturing Facility in India

The companies will co-develop and co-commercialize the lead candidate generated from their earlier collaboration to treat genetic blood disorders.

Vertex and CRISPR Therapeutics Partner on Gene Therapy for Blood Disorders

The Endress+Hauser iTHERM TrustSens hygienic RTD self-calibrates to verify in-line that the sensor is working as designed

Self-Calibrating Temperature Sensor Prevents Undetected Drift

The agency has approved Nucala (mepolizumab) to treat Eosinophilic Granulomatosis with Polyangiitis (EGPA) to GlaxoSmithKline. This indication is the first FDA-approved therapy specifically to treat EGPA.

FDA Approves First Drug for EGPA

SGS has introduced a Sanger sequencing service at its Glasgow, United Kingdom, laboratory to support genetic stability testing and perform identity testing on cell banks, plasmids, and viral seeds/vectors.

SGS Adds GMP DNA Sequencing Capabilities at Glasgow Facility

The new 30,000-L, $150-million biologics manufacturing facility in Wuxi, China, quintuples the company’s existing manufacturing capability.

WuXi Biologics Starts Up Large-Scale, Single-Use Biomanufacturing Facility

Gilead Sciences will acquire Cell Design Labs to further cell-therapy research and development efforts.

Gilead Sciences and Kite to Acquire Cell Design Labs

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes