The evolution of therapeutic modalities drives the adoption of single-use technologies.
Despite a growing number of biosimilar approvals, market uptake remains a challenge.
Given the criticality of fill/finish processes, it is clear that automation is the next technological step.
A collaboration integrates Sartorius Stedim Biotech’s BIOSTAT STR bioreactors and Repligen’s XCell ATF cell-retention control technology to create simplified, scalable equipment for intensified cell culture.
The SciLog SciPure FD System from Parker Bioscience is an automated single-use system for the filtration and dispensing of products into either bottles or bags.
Watson-Marlow Fluid Technology Group added a new actuator suitable for applications where reduced weight is a concern.
Sharing of bioprocessing know-how can help resolve pressing industry problems.
Automation can improve many aspects of bioprocessing, but several hurdles must be overcome before the full range of benefits can be realized.
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
The US Pharmacopeial Convention (USP) is developing a new chapter for rapid sterility testing of short-life products based on the recommendations of a panel of experts and stakeholders.
The company is certified as a manufacturer of pressure vessels and components for use in China.
The new Testa Center in Uppsala, Sweden is a collaborative test bed offering biotechnology equipment from GE Healthcare for process development.
Dompé Farmaceutici’s Oxervate (cenegermin), a topical eye drop, is the first treatment approved by the agency for neurotrophic keratitis, a rare disease affecting the cornea.
FDA grants support US research in continuous manufacturing monitoring and control techniques for bio/pharmaceutical manufacturing at Rutgers, MIT, and Georgia Tech.
Pharmaceutical scientist association announces upcoming term’s board of directors.
The new drug, Onpattro (patisiran), by Alnylam Pharmaceuticals, is in a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.
The agency issued a warning letter to Canadian API manufacturer, Les Produits Chimiques B.G.R, citing cGMP violations at its API facility in Pointe-Claire, Quebec.
The combined companies will provide research- and clinical-grade human immune cells, blood products, and related services.
Avalon and Weill will co-develop bio-production and standardization procedures for CAR-T therapy.
The companies will collaborate on the discovery, development, and commercialization of cell therapies for cancer.
Boehringer Ingelheim joins Oxford BioMedica, UK Cystic Fibrosis Gene Therapy Consortium, and Imperial Innovations to form a partnership for developing a new gene therapy to treat cystic fibrosis.
AuroMedics Pharma issued a voluntary, nationwide recall of two lots of piperacillin and tazobactam for injection, USP 3.375 g due to the presence of particulates identified as glass and silicone material.
The company broke ground on its $200-million, 120,000-ft2 biomanufacturing plant in West Greenwich, RI.
Biopharma seeks alternatives that meet the needs for next-gen biologic drug production.
The companies will work together to develop novel gamma delta T-cell receptor therapies in various cancers.
The changing regulatory and manufacturing environment is ushering in a new approach to drug development.
The quality of the cell lines used to manufacture biopharmaceuticals are crucial for the production of high-quality, stable biopharmaceuticals.
Pfizer will invest nearly half a billion dollars to build a sterile injectable facility in Michigan.
