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

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Industry experts including Pall share their perspectives in this  new e-book. This publication includes regulatory considerations, and identifies key challenges, new developments, recent successes, and areas for improvement facing the industry.

This white paper provides guidance on the implementation of single-use components in cell and gene therapy (CGT) applications. Regulatory overview, manufacturing workflow, and best practices for supplier selection, qualification and validation are discussed in the paper. 

Change Management

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An industry proposal for change notification practices for single-use biomanufacturing systems.

This survey is a key tool for continuous improvement in the ongoing mission of the BioPhorum disposables program to achieve at least 90% right-first-time supplier change notifications for single-use systems (SUS) used in the bioprocessing industry.

 This report summarizes the BPOG/Rx-360 Joint Audit Program (JAP) model approach and the findings from the pilot program involving eight site audits conducted on BioPhorum’s Supply Partner supplier member company sites.

Our organization complements local measures impacting the life sciences and medical device industries that are being implemented by legislators, regulators and other organizations, with the goal of achieving consistent supply chain standards worldwide.

This section is a listing of audit reports that have been completed and are ready for your organization to license.

This paper provides industry perspective on how to assess risk associated with changes in raw materials used in biopharmaceutical manufacturing.

This industry-aligned guidance document identifies required information to support supplier change notification associated with raw materials used in biopharmaceutical manufacturing.

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.

Extractables and Leachables

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Version 2.0 of the BPOG Extractables Protocol 2.0, defines key end-user requirement specifications for single-use components. Arriving 6 years after the original BPOG protocol, this update is the result of strong engagement between biomanufacturers and suppliers, as well as data-driven decision making.

BioPhorum-aligned suppliers have agreed to make information on their datasets easy to find through a central BioPhorum web portal.  In addition, standardized reporting requirements, templates, and FAQs can also be found as part of the BioPhorum Extractables Ecosystem.

A brief overview of what is new and what has changed with the 2020 update to the Biophorum extractables protocol.  See how Pall and end-users have worked closely together including Pall datasets and experiences to simplify and streamline risk assessments with standardized supplier data.

This document summarizes the outcome of the comprehensive review of suppliers’ extractables datasets generated according to the original BPOG Extractables Protocol (2014). The findings serve as the basis of the current BPOG Extractables Protocol (2020).

This article provides insights as to how Pall implemented the BPOG Extractables Protocol for testing single-use components. Sample preparation strategies, analytical methods and laboratory challenges are discussed in detail.

In this article, we compare the extractables profile of autoclaved polyethersulfone (PES) filters generated using the BPOG and the USP <665> extractables protocols. In addition, we share our findings from testing multiple components per the BPOG protocol.

This paper discusses similarities and differences between classical biopharmaceutical (e.g. mAb) and cell and gene therapy (CGT) manufacturing process from an extractables and leachables (E&L) perspective, and  how extractables data generated from standardized protocols (e.g. BPOG, USP <665> may be applied for CGT products and risk assessment. Regulatory consideration and current challenges are also summarized in the paper.

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.

Integrity of Single-Use Systems (SUS)

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The Bio-Process Systems Alliance (BPSA) recognized the need for a guide on the integrity assurance of single-use systems and formed a working group from supplier and end-user companies to discuss the topic and recommend best practices

End-user perspective outlining single-use system integrity risk assessment, strategy, and the measure of impact failure has on manufacturing through to product delivery. Also covered are best practices to ensure integrity all along the lifecycle of the process

 In order to propose and action good practices to ensure single-use system integrity, the Bio-Process Systems Alliance (BPSA) identifies a risk-management approach that can help companies address potential risks both in system manufacturing and in end-user processes

Join leading industry experts Charlotte Masy of GSK and Patrick Evrard from Pall Corporation to gain insights and answers in this webinar from BioPharma Asia on integrity Assurance for Single-Use Systems, an End-User’s Perspective.

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

To ensure continued availability of critical, pre-sterilized bioprocess materials, biomanufacturers, suppliers, and SMEs worked collectively to create a risk assessment and qualification approach for X-ray sterilization of single-use bioprocess equipment. This consensus approach, implements a science-based risk assessment and testing protocol to verify that X-ray sterilization, which is covered by ISO 11137, yields an equivalent impact to bioprocess materials as gamma.

Particulates

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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

This guidance document describes the current basic concepts on sterility assurance and associated procedures for manufacturing and controlling sterile pharmaceutical products in order to advise manufacturers of sterile pharmaceutical products and regulatory personnel responsible for pharmaceutical inspections on sterility assurance of the products processed by terminal sterilization procedures.

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.

Sterile Filter Validation

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This article focuses on the re-use of hydrophilic- or hydrophobic-membrane sterilizing-grade filters applied in liquid-sterilizing applications. The author reviews different approaches that may be defined as re-use, discusses factors to consider when deciding whether to re-use sterilizing-grade filters, and provides a case study that highlights potential risks and considerations for process validation in filter re-use applications.

This article 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.

Here we present data that demonstrates the robustness of Pall’s 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

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.    

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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
or

Tuesday, December 11
8 am PST/11 am EST

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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.

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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.

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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.

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