Manufacturing

Technology Transfer of CMC Activities for MAb Manufacturing

As monoclonal antibody products succeed and advance through development, their manufacturing requirements change. The probability of a smooth and successful technology transfer process depends on several factors. Sending and receiving parties must be well aligned in expectations, which can be facilitated by early and detailed planning and communications.

To help companies developing MAb products, BioProcess Technology Consultants recently published a comprehensive report outlining the complex technical, regulatory and strategic chemistry, manufacturing and control (CMC) activities necessary to successfully advance new MAbs from discovery to first-in-human clinical trials and the market as quickly and economically as possible. Read this informative white paper to learn more.

Approach to Validation & Implementation of Single-Use Systems

While many of the reasons to move to single-use systems have been well defined over the last few years, there are still concerns with the lack of information regarding validation and implementation of the systems. In this on-demand educational webcast, Christopher Mach of Pall Life Sciences details the step-by-step approach to validation and implementation of single-use systems in biopharmaceutical manufacturing. You’ll learn about:

• A Summary of the Regulatory Position Regarding Validation
• Validation Program Key Points
• Pall Approach to Organizing and Operating an Appropriate Validation Program
• Pall Validation Capabilities

Join Mach as he utilizes a core study of extractables/leachables using the Pall AllegroTM Single-Use System to address industry concerns and help illustrate the necessary components of a successful validation program.

Increased Selection Criteria for Production Media

Operators of biotechnology facilities are facing an increase in selection criteria for production media – new ICH and FDA imperatives, new analytics and monitoring, platform production initiatives and more. In this on-demand webcast, William Whitford of Thermo Scientific discusses:

• Reasons for the Increase in Selection Criteria
• Particular Criteria Discovered by Thermo Fisher Scientific
• Application of how Criteria can be Resolved

Join Whitford as he introduces two studies performed at Thermo Scientific that demonstrate how selection criteria can be solved and resolved to provide transparency and ease for biotechnology and bio production operators.