07.14.14 -- Analytical QbD At Teva; Deploying Smart Process Sensors Sensibly
November 10 and 11, 2014 | Hyatt Regency, San Francisco, CA
• Who should attend? Pharma and biopharm executives who form and manage outsourcing partnerships.
• What's on the agenda? Educational sessions focused on best practices and industry leaders’ experiences and lessons learned to help you avoid costly mistakes.
Register today! Space is limited. Brought to you by Life Science Leader magazine, BayBio, and Outsourced Pharma.
Analytical QbD At Teva: Knowledge Is Power Only When You Share It By Trisha Gladd, Editor, Pharmaceutical Online and Bioresearch Online
Rosario LoBrutto is currently senior director, head of development, parenterals at Teva. Throughout his career he has designed, coordinated, and implemented QbD programs and provided risk-management trainings to product development units (quality, analytical, formulation, process chemists), and quality control, regulatory, and operations units. He understands the value of risk assessment and strategy for proactive failure reduction as opposed to reactive trouble shooting. In his interpretation of the ICH Harmonised Tripartite Guideline for Pharmaceutical Development Q9, a guidance document for QbD, LoBrutto breaks the QbD process down into three phases of risk facilitation as it relates to analytics.
Article: Deploying Smart Process Sensors Sensibly By Amber Ratcliff, Analytical Sensors Market Segment Manager, Hamilton Company
Today's demanding biopharmaceutical manufacturing operations require careful control of process conditions, whether during cell culture, purification, or drug product formulation. Process sensors play a critical role in enabling high-performance manufacturing by providing real-time visibility into how a process attribute is changing, as well as the ability to correlate that change with the stage of the process.
The Multisizer 4 COULTER COUNTER provides particle size distributions in number, volume, and surface area in one measurement, with an overall sizing range of 0.4 μm to 1600 μm. Discover the accuracy of the particle size analysis and particle counting abilities of the Multisizer 4.
The Emphaze Hybrid Purifier is a new, single-use clarifying device containing a multimechanism, all-synthetic, Q-functional anion exchange media integrated with a fine particle, bioburden-reduction membrane. The anion exchange media is composed of a quaternary amine hydrogel supported by a fine-fiber, nonwoven scaffold.
Streamlining the regulatory submission process is essential to getting products to market faster today. But you need to create, review, and maintain essential submission-related documentation appropriately, even as regulatory rules and requirements vary and evolve by country and region. And if you’ve outsourced to contract research organizations (CROs), your submission process must enable reliable, seamless collaboration with these resources.
Three 60 by ASI is a completely sanitary, single-use method of removing a sample from a closed system. There are no parts that must be disassembled, cleaned, and reassembled. The entire set (four vessels) can be applied to your fluid holding vessel or transfer line, used, and then discarded.