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Biotech Regulatory Support

Internal & external 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.

Change Management

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

Continuous Processing

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BioPhorum has produced a document on the technology and regulatory gaps in the continuous downstream processing of therapeutic proteins.

Industry Bodies

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ASTM Committee E55 on Manufacture of Pharmaceutical Products was formed in 2003. This Committee addresses issues related to process control, design, and performance, as well as quality acceptance/assurance tests for the pharmaceutical manufacturing industry. Stakeholders include manufacturers of pharmaceuticals and pharmaceutical equipment, federal agencies, design professionals, professional societies, trade associations, financial organizations, and academia. 

Biophorum mission is to create an environment where the global biopharmaceutical industry can collaborate and accelerate their rate of progress, for the benefit of all.

The Bio-Process Systems Alliance (BPSA) was formed in 2005 as an industry-led international industry association dedicated to encouraging and accelerating the adoption of single-use manufacturing technologies used in the production of biopharmaceuticals and vaccines.

The BioProcess Institute (BPI) provides superior consulting, testing and training services to help the biopharmaceutical industry make better drugs. We know how to find the balance between science, regulations, and operations within the complex world of bioprocessing. And we can help you find it, too.

PDA is the leading global facilitator of science, technology and regulatory information, and their mission is to advance pharmaceutical/biopharmaceutical manufacturing science and regulation so members can better serve patients.

ASME BPE  (American Society of Mechanical Engineers: Bioprocessing Equipment) is an international standard developed as an aid for the design and construction of equipment intended for use in the manufacturing of biopharmaceuticals. The standard is approved as an American National Standard by the American National Standards Institute (ANSI).

NIIMBL members include a diverse set of stakeholders, including large and small companies, research institutions, community colleges, non-profit organizations, and state governments, poised to advance the biopharmaceutical manufacturing industry in the United States. Members have the opportunity to collectively revolutionize current biomanufacturing platforms, processes, and educational programs and share in the benefits of these transformative solutions.

Guide to Irradiation and Sterilization Validation of Single-Use Bioprocess Systems- BPI, May 2008, 10-22


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

IPEC (International Pharmaceutical Excipients Council) - Technically Unavoidable Particle Profile (TUPP) Guide

USP <788> Particulate matter in injections, July 1 2012

BioProcess International - Particulate Contamination in Single-Use Systems Challenges of Detection, Measurement, and Continuous Improvement, J. Vogel & K. Wormuth

Parenteral Drug Association (PDA)-Considerations for Design and Use of Container Challenge Sets for Qualification and Validation of Visible Particulate Inspection", May 2012, PDA J. Pharm Sci and Tech 2012

Regulators Guidance to Industry

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Title 21 Food and Drugs (e-CFR Search)

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

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines.

Harmonisation achievements in quality, safety, and efficacy, as well as multidisciplinary guidelines for crosscutting topics.

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


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

The present draft is the first complete revision of the guideline. Amongst other things, it was designed to pay credit to new issues like quality risk management as well as new technologies and procedures. A new structure was developed in close collaboration by the WHO and PIC/S  to maintain a sensible linkage with their standards and recommendations and thereby reach globally agreed standards.

Single-Use User Requirement Toolkit

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Single-use technology is fast growing in the biopharmaceutical industry.  Often, designing new single-use systems involves a long, iterative process between end-user and supplier to ensure quality, regulatory, and technical requirements are met.  Wouldn’t it be convenient if all these requirements were captured in a toolkit? BioPhorum and BPSA have created new templates aligned with industry standards (i.e. ASTM E3051) which will simplify the single-use design process.


Webinars regarding Regulatory information
Webinars regarding Regulatory information
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Our team will examine common regulatory challenges and areas of uncertainty in the implementation of continuous bioprocessing, and suggest practical, total solutions.


Many industries have adopted a one-piece flow approach (continuous manufacturing) to leverage the core reductions in inventory, increased operational flexibility, and greater product consistency and quality that it delivers. However, biopharmaceutical manufacturers have been slow to put continuous processing theory into practice due to the highly-regulated nature of the industry.


In this webinar,  we will examine the evolution of interest in continuous bioprocessing, the advances being made in today’s market, and how the regulatory authorities are responding. We will also offer insight into the technological challenges of implementing continuous bioprocesses, and potential regulatory questions surrounding batch definition, bioburden control, virus clearance, scale-up/down, defect perturbation, design space, etc.


We will also propose effective mitigation strategies for a successful transition to continuous bioprocessing.    


Join Charlotte Masy from GSK and Pall Biotech to learn how suppliers and end-users can collaborate to ensure the highest level of assurance of integrity and sterility in single-use systems. You will learn:

  • The importance of interactions between suppliers and endusers for SUS implementation
  • How to manage sterility assurance concerns
  • How to assess and define the most appropriate mitigation strategy

GSK’s strategic approach for sterility assurance will be illustrated with a case study.

This webcast is being offered twice.  Please select the webcast that is best for your time zone.

Wednesday, December 5
9 am EST/2 pm GMT/3 pm CET

Tuesday, December 11
8 am PST/11 am EST


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.


In this 45-minute webinar, experts from Pall Biotech will discuss the approach and strategy to ensure the highest level of assurance of integrity of SUS in drug substances and drug products processes. They will take into account the life cycle of the SUS; from its manufacturing to end user’s deployment and use.

You will learn about:


  • The industry trends and recommended approach for the assurance of integrity of single-use systems
  • Available solutions for the highest level of assurance of integrity of SUS
  • A new integrity test for Allegro 2D biocontainer assemblies


Moderator: Hélène Pora
Vice President Technical Communication & Regulatory Strategy, Pall Biotech


Hélène leads the technical training and regulatory documentation support within Biotech. She has been instrumental in the development of Pall single-use technologies for the last 20 years, while getting heavily involved in quality and regulatory aspects. She has over 30 years of experience working for the biopharmaceutical industry, the last 27 years within Pall.


The BPOG Leachables Working Group has recently 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, and will include a case study to highlight the importance of the study design.