Understanding USP 665 & Annex 1: What you need to know

Understanding USP 665 & Annex 1: What you need to know

Today's episode focuses on new and upcoming regulations shaping process manufacturing – specifically, Annex I and USP665. To help us understand these regulations and standards, and the impacts associated with each, we brought in Single-Use Specialist, Kevin de Jager from Hitma, a single-use solutions company. Hitma is a company with a mission to help customers reduce risk, save time and reduce costs by delivering the right bioprocess from discovery to fill-finish. Episode 5 Outline: * Part I: USP * Part II: Annex 1 Hosted by Michael Francis, Sr. Product Manager.With special guest and single-use specialist - Kevin de Jager of Hitma

Sponsored Podcast: Advancing Closed-System Performance in CGT

How MicroCNX® Connectors Enable Scalable Cell and Gene Therapy Manufacturing Originally aired on Cell Culture Dish [https://cellculturedish.com/advancing-closed-system-performance-how-cpcs-microcnx-connectors-enable-scalable-cell-and-gene-therapy-manufacturing/] In this podcast, we spoke with Troy Ostreng, Senior Product Manager and David Burdge, Director of Cell and Gene Therapy at CPC about the development of the MicroCNX® aseptic micro-connectors and how they're helping biopharma teams streamline closed-system operations for cell and gene therapies. What unfolded was a detailed and forward-looking conversation that touched on CPC's 47-year legacy, the technical demands of advanced therapies, and the company's plans to drive the future of automation and sterility in manufacturing.

What's Next in Biopharma and Cell & Gene Therapy Processing?

In Episode 3, Todd Andrews Director of Applications and Business Development for CPC Biopharma invites Paul Priebe, a single-use bioprocessing and industry expert to discuss what's next in biopharma and cell and gene therapy processing. A reflection on how we got here, and where we're going. Episode 3 Chapter Outline: 1. Industry reflections: The single-use revolution 2. A default solution: Single-use as a standard manufacturing platform 3. Single-use learnings from yesterday for innovating in the future 4. Looking ahead to the future of bioprocessing and USP 665 5. Impacts of industry organizations that have shaped the future of bioprocessing 6. Addressing the next wave of leaders in the bioprocessing industry groups

Automation, robotics, and reducing risk in cell therapy manufacturing

CPC Biocast is a podcast focused on bioprocessing in the biopharma and cell & gene therapy industries designed to educate, discuss relevant topics with industry experts and to provide best practices. In Episode 2 hosted by Nik Ekman, Application Development Manager for CPC Biopharma, he invites Fred Parietti, Co-founder of Multiply Labs to discuss automation and robotics in cell therapy manufacturing. This episode focuses on automation in cell therapy and reducing the risk of human contamination and critical points of connection during the process. As we think about helping cell therapy manufacturers get life-changing therapies to more patients, reducing risk in the manufacturing process is critical. Introducing robotics and automation into the process and removing any potential for human error is a key part of the future. Multiply Labs [https://multiplylabs.com/] is a company with a mission to build the world's best robots, and use them to make the most advanced therapies widely available. Multiply Labs' robotic technology is the gold standard for the manufacturing of these life-saving products. Episode 2 Chapter Outline: 1. Automation in Cell Therapy and expediting advanced therapies 2. Mimicking the human process steps of technicians to robotics 3. Modularity and standardization in automating cell therapy processing 4. Addressing standardization in the process from regulatory agencies 5. IND filings and rejections due to CMC related issues 6. How do sterile connectors fit into automation?

Understanding modularity and sterile connectors that enable it

CPC Biocast is a podcast focused on bioprocessing in the biopharma and cell & gene therapy industries designed to educate, discuss relevant topics with industry experts and to provide best practices. In Episode 1, hosted by Todd Andrews, Director of Applications & Business Development in CPC Biopharma, he invites Jay Harp, VP of Sales & Operations from Int2 Solutions to discuss all things modularity in bioprocess manufacturing. Episode 1: Chapter Outline 1. Single-use industry revolution 2. Introduction to modularity with discussion on "Big-S" and "Little-S" of standardization 3. Review of what is holding modularity back 4. How has modularity become adopted in the industry 5. Benefits of going modular 6. Impact of supply chain challenges