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

The vaccine is a non-live, recombinant subunit vaccine that combines an antigen and an adjuvant system to trigger a targeted and long-lasting immune response to the shingle-causing virus.

GSK’s Shingles Vaccine Approved in Canada

The company announced plans to expand its viral vector process development facilities in the United States and its cleanroom facilities in the Netherlands for vector-based products.

Batavia Biosciences Expands Viral Vector Facilities

Samsung BioLogics’ second facility adds 152,000 L of mAb drug substance capacity. 

FDA Licenses Second Samsung BioLogics Facility

The committee has voted unanimously to approve Spark Therapeutics’ gene therapy candidate, Luxturna (voretigene neparvovec), for treating a genetically inherited blindness.

FDA Committee Recommends Approval of Spark’s Eye-Disease Gene Therapy

The companies have entered into a strategic collaboration to establish a new cell therapy and regenerative medicine manufacturing platform, which includes a new manufacturing facility in Belgium.

Promethera and Shibuya Partner on New Cell-Therapy Manufacturing Platform

Fluence Analytics’ Argen is a protein and polymer stability monitoring product that uses continuous light scattering measurements to produce an information stream.

Instrument for Continuous Protein and Polymer Aggregation Analysis

Amgen is seeking approval for an additional indication in glucocorticoid-induced osteoporosis for its blockbuster osteoporosis therapeutic, Prolia.

FDA Accepts Amgen’s Application for New Indication of Osteoporosis Biologic

AstraZeneca is seeking approval for its anti-cancer monoclonal antibody, Imfinzi, for treating non-small cell lung cancer in the European Union.

EMA Accepts AstraZeneca’s Application for Lung Cancer Biologic

BARDA has entered a $12-million contract with biopharmaceutical firm Achaogen for the late-stage development of an antibiotic against resistant bacteria, and as a potential treatment for biowarfare agents.

HHS Sponsors Development of Antibiotic-Resistant, Anti-Biowarfare Antibiotic

Johnson & Johnson’s Janssen Sciences Ireland UC will invest more than EUR 300 million (US$355 million) to expand manufacturing capacity for biologic medicines at its Ireland facility.