Extractables studies for chromatography resins based on the adapted requirements of the USP support risk evaluation for chromatography steps.
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Introduction to BioPhorum (BPOG) raw materials risk assessments tool and an overview on risk assessment regulations for raw materials.
Liquid-filled hard capsules: A flexible tool for rapid access to the clinic with poorly soluble and/or highly potent compounds
21 October 2020 | By Lonza Pharma & Biotech
Join our live webinar on 24 November to learn about liquid-filled hard capsule technology has a proven record for addressing complex active pharmaceutical ingredient (API) formulation challenges, including bioavailability enhancement.
A report found the rise in outsourcing, growing popularity of biologics and expanding acceptance of quality-by-design approaches would drive the market expansion.
Find out how to streamline your pharmaceutical operations in a COVID-19 environment.
In this issue you can find articles discussing the supply chain implications of Trump's 'Buy American' order, guidance on how to identify and justify starting materials for regulatory approval by both the EMA and FDA, as well as some of the latest developments in oral biologic drug delivery techniques. Also…
The adaptive ACTIV-5/BET study will test two monoclonal antibody therapies in hospitalised COVID-19 patients to establish if they warrant larger clinical trials.
The US Food and Drug Administration (FDA) has approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) for the treatment of Zaire ebolavirus infection in adults and children.
In combination with inhaled corticosteroids, the monoclonal antibody Dupixent improved lung function and reduced the rate of severe asthma attacks.
The US government will develop and manufacture AstraZeneca’s investigational monoclonal antibody cocktail, AZD7442, a potential prophylactic treatment for COVID-19.
12 October 2020 | By Mettler-Toledo GmbH and Hellma GmbH & Co. KG
Join our live webinar on 3 December to learn about the important UV/Vis spectroscopy-relevant changes in both USP and Ph. Eur. taking a closer look at their impact and the solutions available to ensure compliance.
NoveCite has an exclusive licence to develop and commercialise mesenchymal stem cell therapies to treat acute respiratory conditions such as Acute Respiratory Distress Syndrome (ARDS).