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SMEbiotech

Evoluton of Process Validation During Development

The Evolution of Viral Clearance Evaluation Studies During Development of Biopharmaceutical Products Barry Rosenblatt, Ph.D.

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Viral Clearance Studies How Much Should We Do? Phase I/II (Depends on the Nature, Severity and Stage of the Disease)

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Viral Clearance Studies How Much Should We Do? Phase III

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Biotherapeutic manufacturing processes are at greater risk of contamination than classic small molecule processes and therefore require different control strategies. Understanding the source, options for control, and potential impact of bioburden throughout downstream biopharmaceutical processes is beneficial to process developers, production operators and pharmaceutical microbiologists. Process designs that reduce the risks of bioburden contamination will decrease process related failures and the resulting painful, time-consuming investigations. In this webinar, you will learn: • Biotherapeutic manufacturing processes are at greater risk of contamination than classic small molecule processes and therefore require different control strategies. • Understanding the source, options for control, and potential impact of bioburden throughout downstream biopharmaceutical processes is beneficial to process developers, production operators and pharmaceutical microbiologists. • Process designs that reduce the risks of bioburden contamination will decrease process related failures and the resulting painful, time-consuming investigations. Register for our webinar here: https://bit.ly/3c4q9rr

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Key regulatory documents and regulatory thinking now includes quality by design (QbD). This webinar focuses on how to integrate practical QbD activities into the process and analytical aspects of sterile medicinal product sterilizing filtration and qualification. In this webinar, you will learn to: • Focus on practical QbD terms and approaches • Highlight critical product quality aspects of sterile medicinal products • Develop design and control spaces for sterilizing filtration • Easily integrate QbD into the process and analytical operations in early phase development and into manufacturing phase production Abstract: Final sterilizing filtration is the last operation in downstream processing to assure the sterility of medicinal products. Poorly defined product attributes process parameters may attract regulatory scrutiny, affect final product sterility and patient safety. A better understanding of QbD concepts and principles allows for better process and analytical monitoring and control at both early and final phase production. The webinar will show how currently available process cGMP information can be practically incorporated into QbD product quality attributes and process parameters. This is especially vital for the third party conducted laboratory work such as bacterial retention and leachable studies.

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Today’s viral vector manufacturing processes remain challenging. Process development is a critical enabler to bring safe, effective, sustainable products to market to address patient needs. When done properly, it can reduce the timeline of the project and the cost of producing the therapeutic product. The webinar discusses our strategies for developing lentivirus and adeno associated virus (AAV) and the impact these early decisions can have on commercial readiness. Watch the interactive webinar now: https://bit.ly/2VplwQq

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EXECUTIVE SUMMARY OF ICH GUIDELINES Q5A (R1) AND Q4B ANNEX 2 (R1) VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN – Q4B ANNEX 2 (R1): This document is concerned with testing and evaluation of the viral safety of biotechnology products derived from characterized cell lines of human or animal origin. The scope of the document covers products derived from cell cultures initiated from characterized cell banks. It covers products derived from in vitro cell cultures, recombinant DNA – derived products and also includes products derived from hybridoma cells grown in vivo. Three principal approaches have evolved to control the potential viral contamination of biotechnology products: a) Selecting & testing cell lines and other raw materials, including media components, for the absence of undesirable viruses which may be infectious and/or pathogenic for humans. b) Assessing the capacity of the production processes to clear infectious viruses. c) Testing the product at appropriate steps of production for absence of contaminating infectious viruses. The guideline suggests approaches for the evaluation of the risk of viral contamination and for the removal of virus from the product. Following are the recommended tests for the brief description of a general framework and philosophical background within which the manufacturer should justify the testing that was done; 1) Test for Retroviruses 2) In vitro Assay 3) In vivo Assay 4) Antibody Production Tests TEST FOR EXTRACTABLE VOLUME OF PARENTRAL PREPARATIONS GENERAL CHAPTER – Q4B ANNEX 2 (R1): This annex is the result of the Q4B process for the Test for Extractable Volume of Parenteral Preparations General Chapter. The proposed texts were submitted by the Pharmacopoeial Discussion Group (PDG). The acceptance criteria of this document are same in the three pharmacopoeias. The annex contains the following considerations for the implementation; 1) General Consideration 2) FDA Consideration 3) EU Consideration 4) MHLW Consideration

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P Vevolution

1. The Evolution of Viral Clearance Evaluation Studies During Development of Biopharmaceutical Products Barry Rosenblatt, Ph.D.

3. When is it done in development?

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11. Viral Clearance Studies How Much Should We Do? Phase I/II (Depends on the Nature, Severity and Stage of the Disease)

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