Newsletter | August 8, 2024

08.08.24 -- New 'WEE' Urgency Raised As FDA Requires DSCSA EDDS Interoperability

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Manufacturing cell and gene therapy products is complex and involves multiple challenges, including a unique combination of expensive cell culture solutions and experience. Our experts will discuss the importance of optimized cell media and buffers using the design of classical media formulations to demonstrate the importance of component selection in the formulation process. Join Bioprocess Online August 28th to explore real-world case studies and gain practical insight into improving bioprocess development and consistency.

FOCUS ON REGULATORY

New 'WEE' Urgency Raised As FDA Requires DSCSA EDDS Interoperability

A June meeting showed industry is struggling to meet the DSCSA's November deadline. Eligible companies might find relief in an FDA waivers and exemptions program.

EU GMP Guidelines For Environmental Monitoring: Questions and Answers

Here, PMS Senior GMP Scientist, Mark Hallworth answers questions that arose while presenting on EU GMP Guidelines for Environmental Monitoring. Explore his answers to gain insights into these guidelines.

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AI and machine learning are the buzzwords of the decade, often accompanied by lofty promises — but what do they really mean for biopharma? How can these technologies be adopted to improve biomanufacturing processes, testing, and quality? Join Bioprocess Online Live for an exploration into the practical applications of AI/ML in biomanufacturing, its barriers to adoption, and how regulators can help standardize use across the industry. Registration is free thanks to the support of Atum Bio.

FOCUS ON ANALYTICS & QUALITY

How CSL Behring Worked With EMA/FDA To Develop Hemgenix Potency Assays

Gene therapy products are complicated, and it's hard to know at which step to measure potency. Here's how CSL Behring did it for Hemgenix.

Digital Transformation Essentials: AI Readiness, What Do You Need To Know?

Unlock the full potential of AI and digital solutions with these practical steps to begin moving your BioPharma organization's goals forward with optimized data usage.

The Digital Transformation Of Catalent's Process Development Laboratory

Discover how Catalent was able to create a data model for its bioreactors, resulting in easily contextualized data, time savings in manual tasks, and the ability to share insights in real time.

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Complex protein-based therapies don’t play by the same process-engineering rules as small molecules and traditional biologics. They require developers to see the unforeseen and embrace new roles and responsibilities in sourcing raw materials and outsourced expertise. Successful developers can’t let this winding road slow their time to IND. Join Bioprocess Online Live on August 8th for an interactive discussion on early workflow considerations for complex protein-based therapeutics. Supported by Thermo Fisher Scientific.

ANALYTICS & QUALITY SOLUTIONS

A Software Digitalization Solution For Life Sciences - Honeywell Process Solutions

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