Aug 23, 2016
Sponsored Content
Intensified regulatory scrutiny of data and reporting has increased demand for authentication of documents used in bio/pharma development and manufacturing. Mollie Shields Uehling, CEO of SAFE-BioPharma an association working to provide high-assurance identity trust for cyber transactions, describes the role digital signatures can play in ensuring the integrity of documents used in drug development and manufacturing processes. The discussion includes applications for digital signatures in pharma research, development, and manufacturing; regulatory requirements for document authentication; and how digital signatures can improve document authentication and workflow within organizations and when collaborating with external partners.
Aug 11, 2016
Sponsored Content
Today’s pharmaceutical pipeline requires more flexibility in manufacturing than ever before. Fast, reliable product launches are critical, and a wide range of product and network strategies are needed to support demand for tailored manufacturing solutions. In this episode, we will discuss the roadmap for successful technology transfers and important factors to be taken into account when choosing the right partner.
Aug 11, 2016
Sponsored Content
Orally disintegrating tablets are well known for their advantages in terms of patient compliance and convenience. However, as a freeze dried product, the Zydis® ODT platform offers additional benefits including sublingual delivery of conventional small molecules to avoid first past metabolism and improve bioavailability, stabilization of API nano-particles for improved oral bioavailability of BCS class II & IV compound, potential for sublingual delivery of peptides and vaccine antigens.
Aug 09, 2016
Sponsored Content
What can companies do to prevent risks from occurring? The answer lies in having an automated Risk Management System. This guidebook provides you with a selection of our risk-based literature, all in one place.
Aug 03, 2016
Sponsored Content
This technical paper addresses key topics to consider when designing a fully automated pneumatic conveying system for batch or continuous processes, including an understanding of “Difficult Powders” and their respective poor flow properties, and the challenges in moving these powders into the conveying line from the pick-up point, feeding them at a constant rate, and then getting the powder to discharge from the material receiver
Jul 21, 2016
Sponsored Content
In this whitepaper, we demonstrate the applicability of the ACQUITY QDa Detector for reliable mass determination during subunit analysis of protein-based therapeutics. Routine monitoring of subunit data offers timely detection of variations in manufacturing processes, and can be used to screen for batch-to-batch consistency.
Jun 21, 2016
Sponsored Content
Unauthorized product diversion directly attacks your bottom line and erodes patient safety. Learn how on-dose authentication can safeguard your drug products, provide key business informatics, and improves your financials.
Jun 20, 2016
Sponsored Content
Difficult to Move Powders; The challenge in moving these powders is getting them into the conveying line from the pick-up point, feeding them at a constant rate and getting the powder to discharge from the material receiver.
Jun 01, 2016
Sponsored Content
Liposomal physicochemical characteristics are objectively and accurately measured by using cryo-Transmission-Electron-Microscopy (TEM) in combination with designated image analysis software.
Vironova Analyizing software (VAS) enables reproducible and semi-automated particle detection and classification. Liposome analyzes described include:
• size distribution
• circularity
• level of packaging
• lamellarity
• lipid bilayer thickness
May 23, 2016
Sponsored Content
As FDA guidelines evolve and drug products on the market begin to age, Bio/Pharmaceutical manufacturers face scrutiny of the original methods used to support these products. Therefore, manufacturers must re-evaluate these methods to ensure they comply with current FDA expectations. Some manufacturers are even facing consent decrees imposed by the agency requiring them to bring methods up to current standards within a specified timeframe.
