whitepaper
Whitepaper: EU GMP Annex – sterile manufacturing
This whitepaper considers the latest EU GMP Annex 1 draft and its impact on the control and release of sterile products.
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Excipients
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The importance of disaccharide excipients in biologics
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…
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Formulation, Development & Delivery In-Depth Focus 2021
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.
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Whitepaper: The necessity of E&L qualifications for lyophilised drug products
Lyophilised drug product containers and administration devices consist of the primary packaging, the reconstitution solution container, and the drug administration set.
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Whitepaper: Turbocharging Raman measurements
This whitepaper describes the proprietary HyperFlux™ optical spectrometer designs developed by Tornado Spectral Systems.
whitepaper
Fact sheet: CFS 1200® capsule filling and sealing machine
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…
whitepaper
Interactive PDF: Risk mitigation and quality requirements interactive tool
Risk mitigation interactive tool to guide you through the challenges and quality requirements of your bio-manufacturing process.
webinar
How to master raw material ID testing in 2021
11 November 2020 | By Thermo Fisher Scientific
In this on-demand webinar we explore the evolving role of handheld and portable instruments to drive quality improvements and manufacturing success in 2021.
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Science and risk-based specification setting for excipients
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.
video
On-demand webinar: BioPhorum raw materials risk assessments
Introduction to BioPhorum (BPOG) raw materials risk assessments tool and an overview on risk assessment regulations for raw materials.
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Formulation, Development & Delivery In-Depth Focus 2020
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.
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European Pharmaceutical Review Issue 5 2020
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…
whitepaper
Application note: Disintegration property of ODTs with co-processed excipients
Performance of orally disintegrating tablets (ODTs) with GRANFILLER-D was investigated by the real-time X-ray observation of water penetration into ODTs.
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Whitepaper: The effect of humidity on tablet surfaces containing different types of superdisintegrants
This whitepaper studies the effect of humidity on tablet surfaces containing different types of super disintegrants.
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Whitepaper: Matrix effects on the performance of disintegrants
Superdisintegrants are categorised by their mechanism of action such as wicking, swelling or shape recovery. In this study, the performance of disintegrants from each of these groups was tested in an insoluble, hydrophobic tablet formulation.
