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

Topic

Articles

The US Court of Appeals for the Federal Circuit has decided in favor of Novartis’ Sandoz in rendering the opinion that Amgen cannot use state laws to prohibit or delay the marketing of biosimilars.

Federal Circuit Decides in Favor of Novartis in Biosimilars Patent Dispute with Amgen

FDA has approved a Pfizer biosimilar to J&J’s top-selling anti-inflammatory biologic, Remicade.

FDA Approves Pfizer Biosimilar to J&J’s Remicade

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.

Analytics

Biologics Quality Control: The Growing Need for Accessible Proteomics

Emerging Therapies Drive Analytical Advancements

Analyzing Exabytes