ASTM International says its new standard for single use system manufacturing processes will help to prevent the contamination of biopharmaceuticals with foreign particles.
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There are many challenges faced by the biopharmaceutical industry in order to develop and provide sufficient drugs to treat a growing and ageing population. This article discusses whether continuous processing provides the solution.
The DURYSTA ocular implant has been approved by the FDA to reduce intraocular pressure in open-angle glaucoma or ocular hypertension.
Why do E&L testing? Extractables & leachables studies enable drug sponsors to quantify and identify the risks of potentially toxic leachable impurities migrating into a drug solution from container closure systems, processing equipment or packaging.
7 February 2020 | By OSIsoft
Trustworthiness in data is critical for operations within the pharmaceutical and life sciences industries, whether it is for compliance, operational excellence, reporting or development. Hear the latest findings from OSIsoft’s research in our on-demand webinar.
The US FDA has approved AUDENZ, a vaccine formulated with MF59® adjuvant, as an Influenza A H5N1 vaccine that can be quickly deployed in the event of a pandemic.
Research has predicted that the global single-use bioprocessing market will exhibit a CAGR of 13.6 percent over the forecast period until 2025.
Marketing authorisation in the EU for Baqsimi, the first non-injectable treatment for very low levels of blood sugar, has been recommended by an EMA committee.
Whitepaper: A study of the peristaltic life and pumping performance of three TPE tubing products to assess their suitability for continuous bioprocessing
Drug manufacturers are increasingly adopting continuous bioprocessing to manufacture biologics as efficiently as possible. This is being driven by a need to reduce production costs and prices of pharmaceutical products. Furthermore, the FDA has stated its support for the implementation of continuous bioprocessing. A key consequence of continuous bioprocessing is…
The impact of new and alternative monitoring technologies on labor costs in the laboratory and in manufacturing can be significant.
Innovations in single-use process automation are driving single-use adoption into commercial biologics facilities. Here, Sartorius Stedim Biotech (SSB) shares its latest service offering.
AdvantaPure® manufactures high purity flexible tubing and hose, molded tubing manifolds and filling assemblies, and BioClosures® container closures for single use.
SGS Life Sciences offers tailored study design and testing for extractables and leachables (E&L) in finished pharmaceutical packaging, process equipment and medical devices, and leachables in final product for clients using single-use systems (SUS).