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Points to Consider No. 11: Development, Classification, Manufacture, Control, and Testing of Plasmids and Vectors Used in ATMP Production
PDF Single User
This Points to Consider document is focused on the use of viral vectors for delivery of a therapeutic gene, both in vivo and for ex vivo modification within the overall classification of ATMPs. The topics addressed are diverse and include plasmid and viral vector categorization and control, quality … -
Quality Risk Management: A Practical Guide
PDF Single User
Hardcopies are available for purchase at the Euromed Communications website. Since the publication of the first Quality Risk Management (ICH Q9) guideline in 2005 and the Risk Assessment and Risk Management in the Pharmaceutical Industry: Clear and Simple book by James Vesper in 2006, the pharmaceutical … -
Points to Consider for Microbial Control in ATMP Manufacturing (Single user digital version)
PDF Single user
Since health authorities have not yet published guidelines for a comprehensive control strategy specific to microbiological topics for ATMPs, it is up to the individual ATMP sponsor or license holder to apply these compendial references properly. This Points-to-Consider document provides a summary of … -
Technical Report No.41 Revised 2022 (TR 41): Virus Filtration
PDF Single User
Technical Report No. 41 (Revised): Virus Retentive Filtration, provides a summary of best practices for utilization of virus filtration in process development and manufacturing. The document explains what virus filters are and where they can be used in current and emerging bioprocesses. Recommendations … -
PDA Technical Report No.65 Revised 2022 (TR 65) Technology Transfer (Single user digital version)
PDF Single user
This technical report aims to provide a standardized approach to the technology transfer process. It supplies a matrixed "Reference Guide to Technology Transfer Activities and Deliverables," which can be used to coordinate cross-functional technology transfer activities that help achieve operational … -
Quality by Design - An Indispensable Approach to Accelerate Biopharmaceutical Product Development (single user digital version)
PDF Single user
PDA's book, Quality by Design — An Indispensable Approach to Accelerate Biopharmaceutical Product Development, edited by industry experts Cristiana Campa, Vaccines Technical R&D, GSK, and M. Amin Khan , Vaccines R&D, GSK, is an important contribution to the ongoing dialogue for accelerating … -
PDA Technical Report No. 1, Revised 2007, (TR 1) Validation of Moist Heat Sterilization Processes Cycle Design, Development, Qualification and Ongoing Control (single user digital version)
PDF Single user
PDA's original Technical Monograph No. 1, Validation of Steam Sterilization Cycles, published in 1978, introduced the principles of steam sterilization to an entire generation of pharmaceutical scientists and engineers. The revision retains a focus on the microbiology and engineering of moist … -
PDA Technical Report No. 1, Revised 2007, (TR 1) Validation of Moist Heat Sterilization Processes Cycle Design, Development, Qualification and Ongoing Control
Book
PDA's original Technical Monograph No. 1, Validation of Steam Sterilization Cycles, published in 1978, introduced the principles of steam sterilization to an entire generation of pharmaceutical scientists and engineers. The revision retains a focus on the microbiology and engineering of moist …
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