Biotech Regulatory Portal

Useful Resources

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.

Change Management

Application tools, processes, and information for effective change management and support.

Continuous Processing

Roadmap for regulatory and technology within continuous processing.

Extractables and Leachables

Current extractables and leachables documentation encompassing regulatory requirements and relevant scientific articles.

Industry Bodies

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.

Irradiation

Information and guides for irradiation and sterilization of filters, capsules, components, and single-use systems.

Particulates

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.

Webinars

Links to a collective list of webinars, including topics such as: single-use technologies; integrity assurance; and many more.

Cell and Gene Therapy

Insights on Successful Gene Therapy Manufacturing and Commercialization

An e-book published by Cell Culture Dish prompted by developments in gene therapy. Pall and other leaders in gene therapy discuss the means to achieve success within the industry. Themes include production, regulation, analysis, major advances and achievements, and future technological challenges.

The Role of Single-Use Polymeric Solutions in Enabling Cell and Gene Therapy Production

A white paper by Bio-Process Systems Alliance (BPSA) detailing single-use technology in cell and gene therapy (CGT). This paper discusses the similarities in the bioprocessing and CGT industries, details the regulatory and documentary requirements, explains how to increase productivity, and introduces the rationale, terminology, and technology used.

Quality by Design (QbD) for Adeno-Associated Virus (AAV)

White paper discussing how QbD can be applied to adeno-associated virus gene therapy products.

Change Management

An Industry Proposal for Change Notification Practices for Single-Use Biomanufacturing Systems

A proposal by BioPhorum and BPSA to address the inefficiencies in change notification practices, which are holding up the adoption of single-use systems.

Single-Use System Change Notification Scorecard Survey

A survey published by BioPhorum and used in the bioprocessing industry to enable businesses to reach a minimum of 90% error-free supplier change notifications for single-use systems (SUS).

BPOG/Rx-360 Joint Audit Program Workstream – Pilot Program Summary Report

A report by BioPhorum summing-up the conclusions drawn from a trial of eight audits carried out by the consortium of drug buyers and suppliers. The report is the outcome of an agreement to share access to a library of audited information – speeding up the process and reducing costs.

Rx360 An International Pharmaceutical Supply Chain Consortium

Link to the Rx360 website, a group set up to deal with issues affecting the supply consistency and safety of pharmaceutical and biomedical equipment worldwide and promoting continuous improvements within the industry.

Rx360 Licensable Reports Requests

A comprehensive list by Rx360 of completed audits which are available for businesses to license and use.

Raw Material: A Holistic Approach to Raw Material Risk Assessments Through Industrial Collaboration

A paper published by BioPhorum describing a methodical technique for assessing the risk of using raw materials for certain roles in the biopharmaceutical industry. The assessment uses standard questions to identify the associated risk and fitness for function from a library of attributes.

Raw Materials: Supplier Change Notifications: Change Areas and Requirements

This BioPhorum document provides suppliers to the biopharmaceutical industry with guidance about the information required by their buyers to help them to efficiently monitor the large number of changes in material attributes. Targeting relevant information minimizes costs, reduces re-work delays, and is mutually beneficial.

Why this SUS Audit Guide Will Reduce Industry’s Audit Burden?

An article by BioPhorum detailing the benefits of the single-use system audit guide published to support application of the joint audit programme model.

Continuous Processing

Biomanufacturing Technology Roadmap

This document published by BioPhorum uses a typical therapeutic protein production system as a model to identify key target gap-areas which are vital roadblocks to making continuous processing a possibility.

Extractables and Leachables

Biophorum Best Practice Guide for Extractables Testing of Polymeric Single-Use Components in Biopharmaceuticals Manufacturing (2020 Protocol Update)

BioPhorum’s updated issue of the ‘best practice’ manual for extractable testing allows the supplier to tailor key factors for single-use systems. Ideas reflect the views of industry experts and can help reduce testing requirements and provide guidance throughout the testing process.

BioPhorum Extractables Portal & Ecosystem

A central portal produced by BioPhorum which acts as a library of extractables data from leading suppliers of single-use systems.

BioPhorum Extractables Requirements for Single-Use Systems. The Last Chapter

An article written by James Hathcock and Ken Wong, published in BioPharma Asia, detailing the updated 2020 version of the 2014 project by biomanufacturers which improved and simplified customer access to standardized extractables testing data for single-use systems. Improved processes as the result of supplier/customer collaboration.

Extractables: A Comprehensive Review of BioPhorum Standardized Extractables Testing Data - a Deep Dive into Similarities, Differences and Trends Across Extraction Solvents and Time Points

A document published by BioPhorum providing an analysis of extensive extractables testing and detailing the commonalities and dissimilarities between solvent materials. The results were used as a framework for the extractables testing protocol.

Implementation of the BPOG Extractables Testing Protocols: Working with Multiple Single-Use Components

An article published in BioProcess International explaining how, despite the benefits of single-use systems, their widespread adoption has increased the potential that leachables will impact patients’ safety. The importance of implementing standardized testing and reporting, and shared protocols is highlighted and BioPhorum and USP protocols assessed, with solvent extraction evaluated for different materials.

Implementation of the BPOG Extractables Testing Protocols: Comparing USP and BPOG Extractables Data for Autoclaved Polyethersulfone Filters

An article published in BioProcess International comparing the extractables profile of autoclaved polyethersulfone (PES) filters tested using BioPhorum and USP<665> protocols.

Extractables/Leachables Considerations for Cell & Gene Therapy Drug Product Development

A paper by BPSA which assesses the difference between traditional methods and newer cell and gene therapy (CGT) techniques with regard to extractables and leachables. With potential interactions between single-use plastics and CGT the amount of leachables in the final product needs to be measured and controlled. This paper considers the risks, regulations and difficulties involved.

Industry Bodies

ASTM – E55 Committee

The ASTM committee E55 on Manufacture of Pharmaceutical Products was established in 2003 to look at issues related to process control, design, performance, and quality acceptance/assurance testing in the pharmaceutical manufacturing industry.

BioPhorum

Since 2004 BioPhorum, a group of over 120 manufacturers and suppliers, has been working towards developing a technology roadmap that defines supply practices whilst developing and promoting best practice in multiple fields within the pharmaceutical and biopharmaceutical industries.

Bio-Process Systems Alliance (BPSA)

Formed in 2005 the industry-led Bio-Process Systems Alliance (BPSA) is an international association promoting the swift and safe adoption of single-use technologies in the production of biopharmaceuticals and vaccines.

Bioprocess Institute (BPI)

The BPI is a team of engineers and specialists who provide consultation, testing, and training services to biopharmaceutical suppliers and end users in pursuit of assisting the industry to produce better drugs.

PDA

The Parenteral Drug Association (PDA) is working to provide a better service to patients by improving pharmaceutical and biopharmaceutical manufacturing science and regulation.

ASME

The American Society of Mechanical Engineers Bioprocessing Equipment (ASME BPE) is an international standard for use as an aid when designing and constructing biopharmaceutical manufacturing equipment. The standard has been approved as an American National Standard by the American National Standards Institute (ANSI).

NIIMBL

The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) gives stakeholders the opportunity to improve and advance the biopharmaceutical manufacturing industry in the United States. Members can share their advances in platforms, processes and educational programs.

Integrity of Single-Use Systems (SUS)

Design, Control and Monitoring of Single-Use Systems for Integrity Assurance

Resource from the Bio-Process Systems Alliance (BPSA) on the design, control, and monitoring of single-use systems for integrity assurance.

Integrity Assurance for Single-Use Systems: End-User Perspective Article

An article by Charlotte Masy and Jean-Yves Bauer published in BioPharma Asia on single-use system integrity from an end-user perspective from manufacturing to product delivery, including impact failure. This article also discusses best practice to ensure integrity throughout the process lifecycle.

Recommended Practices for Assuring Integrity of Single-Use Systems

The Bio-Process Systems Alliance (BPSA) approach to proposing and actioning good practices using a risk management approach for both system manufacturing and end-user processes.

Integrity Assurance for Single-Use Systems: An End-User’s Perspective Webinar

A webinar from BioPharma Asia with industry experts Charlotte Masy of GSK and Patrick Everard of Pall Corporation on an end user’s perspective of integrity assurance for single-use systems.

Irradiation

A Guide to Irradiation and Sterilization Validation of Single-Use Bioprocess Systems

A guide by the irradiation and sterilization sub-committee of the Bio-Process Systems Alliance (BPSA) intended to give information and recommendations on gamma irradiation of single-use systems used in biopharmaceutical manufacturing processes.

X-Ray Sterilization of Single-Use BioProcess Equipment: Part 1

A white paper published by BPSA that details the X-ray sterilization of single-use bioprocess equipment using a science-based risk assessment in accordance with ISO 11137.

Particulates

2020 Recommendations for Testing, Evaluation, and Control of Particulates from Single-Use Process Equipment

A paper published by BPSA to support the single-use technology industry with particulate testing, evaluation, and control throughout the lifecycle of their single-use systems.

Technically Unavoidable Particle Profile (TUPP) Guide

A guide produced by The International Pharmaceutical Excipients Council (IPEC) to provide guidance and best practice in identifying and determining the origin of technically unavoidable particles in excipients.

USP <788> Particulate Matter in Injections

USP <788> Particulate Matter in Injections The United States Pharmacopeial (USP) Convention <788> on Particulate Matter in Injections published on July 1, 2012.

Particulate Contamination in Single-Use Systems: Challenges of Detection, Measurement, and Continuous Improvement

An article by James Vogel and Klaus Wormuth published in BioProcess International discussing the current particulate measurement techniques, and the challenges faced in developing standardized measurement techniques for single-use systems.

Considerations for Design and Use of Container Challenge Sets for Qualification and Validation of Visible Particulate Inspection

An article by James A Melchore Jr. and Dan Berdovich published in the Parenteral Drug Association (PDA) Journal of Pharmaceutical Science and Technology. The article looks at the design and use of challenge sets for particulate validation and inspection studies.

Regulators Guidance to Industry

FDA Code of Federal Regulations

Title 21 Food and Drugs (e-CFR Search).

FDA Chemistry Manufacturing and Controls (CMC) Guidance for Industry (GFIs)

Of particular interest:-

FDA Elemental Impurities in Drug Products Guidance for Industry
Container Closure Systems for Packaging Human Drugs and Biologics, Guidance for Industry, MAY 1999

ICH Guidelines

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) website giving access to information on their achievements and multidisciplinary guidelines.

Of particular interest:

M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk Guidance for Industry
Q3C (R7) Impurities: Guideline for Residual Solvents
Q4B Annex 3(R1) – Test for Particulate Contamination: Sub-visible Particles General Chapter
Q9 Quality Risk Management

EMA Search Scientific Guidelines

Of particular interest is:- Guideline on Plastic Immediate Packaging Materials

PMDA Guidance on the Manufacture of Sterile Pharmaceutical Products produced by Terminal Sterilization

A guide by the Pharmaceutical and Medical Devices Agency (PMDA) to advise manufacturers and regulatory personnel on the basic concepts of sterility assurance and procedures for products processed by terminal sterilization procedures.

Revision of Annex 1 - Manufacture of Sterile Medicinal Products

After the introduction of a new structure being developed by the World Health Organisation (WHO) in close collaboration with the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) this document was revised to address new issues such as quality risk management and new technologies and procedures.

Single-Use User Requirement Toolkit

A toolkit developed by BioPhorum and BPSA with new templates to aid and simplify the design of new single-use systems in accordance with industry standards (i.e., ASTM E3051) to ensure quality, regulatory and technical requirements are met.

Sterile Filter Validation

Considerations on Reuse of Sterilizing-Grade Filters

An article by Jerold Martin published in Pharmaceutical Technology looking at various approaches to reuse of sterilizing grade filters in liquid sterilization, considerations in deciding whether to reuse sterilizing grade filters, and highlighting considerations and potential risks of process validation in filter reuse applications.

A Risk Based Approach to Validation Studies for Sterilizing Filtration and Single-Use Systems

This article by Pall published in BioPharma Asia focuses on the Quality by Design (QbD) risk-based approach initiative and how the Question based Review (QbR) checklist and Quality Overall Summary (QOS) approach are used to review the validation of a drug process and as a starting point to assess risk, and whether an Abbreviated New Drug Application (ANDA) or New Drug Application (NDA) could help manufacturers to maximize the assurance of sterility of their process and meet the expectations of the regulators.

Viral Safety – Practical Solutions for Risk Control

Here Pall presents data that demonstrates our robust virus clearance product portfolio, as well as strategies for incorporating QbD into virus safety and guidance to help optimize virus clearance trials for increased patient safety. Data from these studies demonstrates that any virus clearance steps are robust, and adequately represent potential worst-case processing conditions.

Webinars

Driving Quality and Responsiveness in Single-Use Technologies

Single-use technologies require a shift of responsibility from biomanufacturers to suppliers to enable production of safe and reliable drugs. One of the pre-requisites for efficient supply is to have standardized processes to design and manufacture single-use systems. We have developed a unique design, quality and business tool to drive quality and responsiveness, and to support standardization of single-use technologies.

Dr Hélène Pora will take you through the functionalities of this system and demonstrate what benefits it brings to end users when implementing single-use technologies in a regulated environment.

Ensure Integrity of Your Single-Use Systems

A webinar on assurance of integrity of single-use systems (SUS). Experts from Pall discuss the approach and strategy to ensure the highest level of assurance of integrity of SUS in drug substance and drug product processes. The life cycle of the SUS; from its manufacturing to end user’s deployment and use is taken into consideration.

Single-Use Systems: Leachable Study Design for Single-Use Components

The BioPhorum (previously BPOG) Leachables Working Group published a Best Practice guide for Leachables. It was developed to help biopharmaceutical and vaccines manufacturers to develop science-based, robust, and efficient approaches to handling the risk of leachable compounds that is associated with increasing use of single-use systems in manufacturing processes.

The Best Practice guide is composed of three parts:

The risk assessment model
Leachable study design
Analytical methods

This webinar provides insight into the application of the best practices for leachables study design by end users.

Accelerator℠ Documentation Center

Useful Resources

Cell and Gene Therapy

Change Management

Continuous Processing

Extractables and Leachables

Industry Bodies

Integrity of Single-Use Systems (SUS)

Irradiation

Particulates

Regulators Guidance to Industry

Single-Use User Requirement Toolkit

Sterile Filter Validation

Webinars

Cell and Gene Therapy

Insights on Successful Gene Therapy Manufacturing and Commercialization

The Role of Single-Use Polymeric Solutions in Enabling Cell and Gene Therapy Production

Quality by Design (QbD) for Adeno-Associated Virus (AAV)

Change Management

An Industry Proposal for Change Notification Practices for Single-Use Biomanufacturing Systems

Single-Use System Change Notification Scorecard Survey

BPOG/Rx-360 Joint Audit Program Workstream – Pilot Program Summary Report

Rx360 An International Pharmaceutical Supply Chain Consortium

Rx360 Licensable Reports Requests

Raw Material: A Holistic Approach to Raw Material Risk Assessments Through Industrial Collaboration

Raw Materials: Supplier Change Notifications: Change Areas and Requirements

Why this SUS Audit Guide Will Reduce Industry’s Audit Burden?

Continuous Processing

Biomanufacturing Technology Roadmap

Extractables and Leachables

Biophorum Best Practice Guide for Extractables Testing of Polymeric Single-Use Components in Biopharmaceuticals Manufacturing (2020 Protocol Update)

BioPhorum Extractables Portal & Ecosystem

BioPhorum Extractables Requirements for Single-Use Systems. The Last Chapter

Extractables: A Comprehensive Review of BioPhorum Standardized Extractables Testing Data - a Deep Dive into Similarities, Differences and Trends Across Extraction Solvents and Time Points

Implementation of the BPOG Extractables Testing Protocols: Working with Multiple Single-Use Components

Implementation of the BPOG Extractables Testing Protocols: Comparing USP and BPOG Extractables Data for Autoclaved Polyethersulfone Filters

Extractables/Leachables Considerations for Cell & Gene Therapy Drug Product Development

Industry Bodies

ASTM – E55 Committee

BioPhorum

Bio-Process Systems Alliance (BPSA)

Bioprocess Institute (BPI)

PDA

ASME

NIIMBL

Integrity of Single-Use Systems (SUS)

Design, Control and Monitoring of Single-Use Systems for Integrity Assurance

Integrity Assurance for Single-Use Systems: End-User Perspective Article

Recommended Practices for Assuring Integrity of Single-Use Systems

Integrity Assurance for Single-Use Systems: An End-User’s Perspective Webinar

Irradiation

A Guide to Irradiation and Sterilization Validation of Single-Use Bioprocess Systems

X-Ray Sterilization of Single-Use BioProcess Equipment: Part 1

Particulates

2020 Recommendations for Testing, Evaluation, and Control of Particulates from Single-Use Process Equipment

Technically Unavoidable Particle Profile (TUPP) Guide

USP <788> Particulate Matter in Injections

Particulate Contamination in Single-Use Systems: Challenges of Detection, Measurement, and Continuous Improvement

Considerations for Design and Use of Container Challenge Sets for Qualification and Validation of Visible Particulate Inspection

Regulators Guidance to Industry

FDA Code of Federal Regulations

FDA Chemistry Manufacturing and Controls (CMC) Guidance for Industry (GFIs)

ICH Guidelines

EMA Search Scientific Guidelines

PMDA Guidance on the Manufacture of Sterile Pharmaceutical Products produced by Terminal Sterilization

Revision of Annex 1 - Manufacture of Sterile Medicinal Products

Single-Use User Requirement Toolkit

Single-Use User Requirement Toolkit

Sterile Filter Validation

Considerations on Reuse of Sterilizing-Grade Filters

A Risk Based Approach to Validation Studies for Sterilizing Filtration and Single-Use Systems

Viral Safety – Practical Solutions for Risk Control

Webinars

Driving Quality and Responsiveness in Single-Use Technologies

Ensure Integrity of Your Single-Use Systems

Single-Use Systems: Leachable Study Design for Single-Use Components

View all Biotech Webinars

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