Challenges and solutions to adopting MALDI technology for filamentous fungi ID with emphasis on sample preparation and database development.
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Many biologic formulations use a variety of high-purity injectable grade disaccharide excipients to ensure functionality and stability of the final product. In this article, Sunil Kumar Nataraj, Bastiaan Dickhoff and Thontesh GC explore the use of these sugars in the stabilisation of biologics and provide recommendations to manufacturers for enhancing…
Download this in-depth focus to explore the use of disaccharide excipients in stabilising biologic drugs and learn about a novel technique for investigating drug-nanocarrier interactions.
Lyophilised drug product containers and administration devices consist of the primary packaging, the reconstitution solution container, and the drug administration set.
At Lonza, we have developed our CFS 1200® capsule filling and sealing machine as part of our Lonza Engine™ portfolio. Used with our Capsugel® capsules, pharmacies can automate this process to optimise operations and accuracy. This fact sheet will introduce you to its handling and sealing capabilities, key benefits, performance…
Risk mitigation interactive tool to guide you through the challenges and quality requirements of your bio-manufacturing process.
Reducing unnecessary regulatory burden relating to excipients is important for any pharmaceutical manufacturer. In this article, Sunil Kumar Nataraj, Bastiaan Dickhoff and Kalyan Janjanam discuss a rational basis for controlling and specifying conflicting excipient attributes to avoid potentially tedious and complex regulatory processes.
Introduction to BioPhorum (BPOG) raw materials risk assessments tool and an overview on risk assessment regulations for raw materials.
In this in-depth focus experts provide guidance on how to select starting materials for API's and discuss how to specify exipients to reduce downstream regulatory burdens.
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…
Performance of orally disintegrating tablets (ODTs) with GRANFILLER-D was investigated by the real-time X-ray observation of water penetration into ODTs.