Here you will find links to supporting resources, including white papers, professional societies, industry interest groups, and webinars. Click an icon to learn more.
Cell and Gene Therapy
A range of resources covering topics such as process development, upstream, and downstream applications, and regulatory considerations.
Application tools, processes, and information for effective change management and support.
Extractables and Leachables
Current extractables and leachables documentation encompassing regulatory requirements and relevant scientific articles.
Industry bodies committed to advancement through development, support, promotion, and regulation of professional standards.
Integrity of Single-Use Systems (SUS)
Resources disseminating the development and application of integrity assurance to single-use systems to ensure product integrity for end-users.
Information and guides for irradiation and sterilization of filters, capsules, components, and single-use systems.
A collection of particulate information for filters, capsules, components, and single-use systems.
Regulators Guidance to Industry
Multidisciplinary guidelines for industry to ensure the harmonization of quality, safety, and efficacy.
Single-Use User Requirement Toolkit
Toolkit capturing single-use system design process requirements to ensure quality, regulatory, and technical requirements are met.
Sterile Filter Validation
Sterile filter validation resources for risk-based approaches, requirements, regulations, and applications for filtration and single-use systems.