Guides

Guides offer practical advice on regulatory initiatives by providing effective, cost-efficient approaches and encouraging innovation and technological advances while achieving regulatory compliance. They typically focus on the “what”, but may also provide some information on implementation.

Language
English
Guides

Guide: ATMPs - Allogeneic Cell Therapy

Published: January 2024 Pages: 144 Table of Contents Special Pricing for Emerging Economies Advanced Therapy Medicinal Products (ATMPs) are based on genes, cells, or tissues delivered to patients to provide a therapeutic benefit based on a specific
Guides

Guide: ATMPs - rAAV Comparability & Lifecycle Mgmt

Published: January 2024 Pages: 98 Table of Contents Special Pricing for Emerging Economies As gene therapy products race towards the clinic and commercial launch, sponsor companies are faced with significant hurdles posed by evolving manufacturing
Guides

Guide: 503B Compounding

Published: August 2023 Pages: 122 Table of Contents Special Pricing for Emerging Economies An ISPE survey of compounding pharmacies and regulators overwhelmingly demonstrated that 503B outsourcing facilities could benefit from comprehensive guidance
Guides

Guide: ATMPs - Autologous Cell Therapy

Advanced Therapy Medicinal Product (ATMP) therapies include cells, engineered tissues, or the manipulation of the patient’s genome. This is in contrast with traditional manufacturing processes for compounds that are synthetically derived (i.e., small molecule) or proteins or peptides expressed by cellular systems (i.e., large molecule biopharmaceuticals). ATMPs are based on genes, cells, or tissues delivered to patients to provide a therapeutic benefit based on a specific target of interest.
Guides

Guide: Biopharmaceutical Process Development & Manufacturing

The ISPE Guide: Biopharmaceutical Process Development and Manufacturing focuses on the development and the process approaches and practices involved in providing cost effective, regulated manufacturing of biopharmaceutical products in a timely manner that meet their intended use.
Guides

Guide: Cleaning Validation Lifecycle - Applications, Methods, & Controls

This guide provides a hands-on approach to support the life science industry in the development and establishment of compliant cleaning programs that meet or exceed regulatory expectations.