Whitepapers

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.
Oct 12, 2018
Sponsored Content
By Merck
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.
Oct 08, 2018
Sponsored Content
Informative packaging serialization requirements & deadlines with keys to combating worldwide drug counterfeiting. Topics include supply chain serialization techniques like Microscopic RFID Tags, Security Labels, Invisible Inks, and Track-and-Trace Technologies.
Oct 04, 2018
Sponsored Content
• A new excipient can help tackle the challenge of an unstable protein. • KLEPTOSE BioPharma provides anti-aggregation stability.
Oct 04, 2018
Sponsored Content
By Schott
• Manufacturers must reduce the risk of damage to biologics from E&L. • Considerations for prefilled syringes.
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