Biotech Regulatory Support
Here you will find links to supporting resources, including white papers, professional societies, industry interest groups, and webinars. Click an icon to learn more.
Application tools, processes, and information for effective change management and support for our customers
Extractables and Leachables
Current extractables and leachables documentation encompassing available product data, regulatory requirements, and relevant scientific articles
Industry bodies committed to the advancement of both knowledge and practice through the development, support, promotion, and regulation of professional standards for technical and ethical competence
Integrity of Single-Use Systems (SUS)
Resources disseminating the development and application of integrity testing to single-use systems to ensure product integrity for end-users
A collection of particulate information encompassing recommendations, evaluations, controls and applications for 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
Toolkits capturing requirements for the design process of new single-use systems 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
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.
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.
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.
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.
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.
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
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
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 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.
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.
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.
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.