Whitepapers

Oct 23, 2018
Sponsored Content
Identifying counterfeit drugs has become an area of increasing focus for regulatory authorities and for pharmaceutical companies. Raman spectroscopy is highly specific and can differentiate between materials with similar chemical structures.
Oct 19, 2018
Sponsored Content
By Almac
Development of new therapeutics demands substantial investment of time and capital, frequently with low chances of success. As a result, there is huge pressure to deliver reduced timelines and realise drug development programmes. Scientists involved in development must balance opportunities to mitigate risk, and increase efficiency whilst maintaining quality. At Almac, we understand that developing therapeutics with a focus on delivery is fundamental to achieving success both in developmental phases, and in the final product.
Oct 18, 2018
Sponsored Content
This paper outlines the basics of cleaning validation and discusses the support services you should seek from your critical cleaning products supplier to optimize your cleaning validation process.
Oct 18, 2018
Sponsored Content
The introduction of on-dose product identification technologies provides the pharmaceutical industry with a powerful new tool to manage supply-chain risk.
Oct 16, 2018
Sponsored Content
• Firms can benefit from Patheon’s Quick to Clinic program for biologics • Suite of offerings puts biologics on the fast-track to FIH trials
Oct 15, 2018
Sponsored Content
Learn how Roquette are Improving consumer compliance by relying on Roquette’s excipients to formulate stable, easy-to-administer Oral Disintegrating Tablets (ODT)
Oct 15, 2018
Sponsored Content
Roquette is leading the Way in Biologic Drug Formulations through Innovation in Protein Stabilization. Download the article to see how A new excipient can help tackle the challenge of an unstable protein.
Oct 15, 2018
Sponsored Content
Patient wellbeing and quality of life greatly depend on medicine acceptance. Learn how Roquette are leading the way taste masking technology.
Oct 15, 2018
Sponsored Content
From injectable and dialysis solutions, to biopharma and oral dosage formulations. Roquette shares its latest innovations:
Oct 12, 2018
Sponsored Content
Adoption of single-use systems adds a new layer of complexity to risk assessment. Single-use technology is now present in higher risk aseptic processing applications, such as the final sterile filtration step after formulation of the drug substance, and this can present new challenges for traditional risk assessment programs. This white paper offers insight into current and expected industry and regulatory requirements for single-use pharmaceutical manufacturing systems, such as more detailed extractables and material qualification data. A review of single-use system quality and regulatory documentation based on these requirements is presented, which will make risk assessments, based on ICH Q9 guidance, more efficient for the sterile drug product manufacturer.
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