Microbial Control

This workstream is driving application of effective microbial control strategies for manufacturers of low-bioburden bulk biologics and developing associated best practice guidance.

Regulatory attention is intense and current guidance is not comprehensive

During site inspections and BLAs Regulators are closely scrutinizing bioburden controls during site inspections and BLAs and companies are feeling increasingly exposed. The issue is compounded by gaps in the guidance for biotech products. Automated methods are proving awkward to validate and commercialize. Regulators are expecting a higher level of demonstrated control and different agencies have different expectations, leading to high regulatory risk.

Establishing industry protocols to eliminate microbial contamination issues

Members are working towards harmonized industry protocols to address immediate issues, optimize validation and robust operation of micro methods and eliminate microbial contamination issues in production processes.

By addressing subjects of concern to regulators, feedback during regulatory inspection will be more positive and reduce risk to license to operate. It will also result in higher process capability, better data integrity in micro labs, improved quality and improved compliance. Achieving 100% microbial contamination prevention will reduce the cost of poor quality.

Microbial Control deliverables

DeliverableDateDetailsDownload

Microbial Control: Detection of Cutibacterium acnes, a high-risk aerotolerant anaerobe recovered in the biopharmaceutical industry

17 August, 2021
507.35 KB
567 downloads

Microbial control: Disinfectant efficacy: Understanding the expectations and how to design effective studies that include leveraging multi-site data to drive an efficient program

21 May, 2020Link

Microbial control: Risk assessment of traditional culture-based microbiological tests requiring contemporaneous verification

31 March, 2020
249.82 KB
394 downloads

Microbial control: Microbiological control for affinity capture chromatography processing: an industry perspective

13 May, 2018
446.65 KB
220 downloads

Microbial control: Mold control and detection in biological drug substance facilities: an industry perspective

31 October, 2017
435.98 KB
557 downloads

Microbial control: Microbial monitoring for biological drug substance manufacturing: an industry perspective

2 May, 2015
625.73 KB
295 downloads

More related workstreams

Our workstreams focus on the areas with the greatest impact across the industry. Led by science, our members are problem-solving today’s sustainability issues. By working with the regulatory governance community, they are also creating future-ready outcomes for the industry.

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Advanced Therapy Medicinal Products

Advanced Therapy Medicinal Products support the quest for better and faster development of cell, gene and RNA therapies​ through connecting therapy developers, contract manufacturing, and testing organizations to gain an understanding and respond to the challenges faced by the advanced therapeutics industry.

Development Group

Development Group accelerates and improves the development process of biopharmaceutical medicines for the benefit of the patient. Replacing isolation with collaboration by providing a “safe” space where subject matter experts can work on sharing solutions and best practice on emerging industry trends, implementation of new technologies and common issues whilst ensuring their intellectual property and confidentiality is protected.

Drug Substance

Drug Substance advances excellence in drug substance manufacturing and testing, acting as an industry voice to accelerate technology adoption, implement post-approval change more rapidly and increase confidence in maintaining compliance.

Fill Finish

Fill Finish accelerates development and acceptance of sustainable world-class filling and packaging operations for drug product which meets the future needs of patients. Through innovative solutions resulting from the sharing of expertise, we can overcome common performance challenges and deliver on quality and regulatory compliance.

Information Technology

Information Technology accelerates digital maturity across the ​global pharmaceutical manufacturing industry.

Quality

BioPhorum Quality provides a dedicated, safe space for quality professionals from biomanufacturers and contract organizations to coalesce and enhance effective collaboration to address shared industry challenges.

Regulatory-CMC

Regulatory CMC brings leaders together who have a common goal – to improve access to medicines through innovation in the Regulatory ecosystem. It provides a dedicated space for strategic leadership and a coordinated industry voice, to move from divergence to convergence.

Supply Chain to Patient

Supply Chain to Patient transforms the performance of global pharmaceutical clinical and commercial outbound supply chains through industry collaboration by creating transparent patient-centric, resilient and agile E2E supply chains, that consistently deliver high-quality medicines ensuring an uninterrupted supply to patients.

Supply Partner

Supply Partner is a trusted advisory group and collaboration that is the engine for driving change across the global industry for all things relevant to the inbound supply chain. Addressing the challenges of complexity, resilience, cost, sustainability, and innovation.

Sustainability

Sustainability enables the industry’s transition to a low carbon, circular future – supporting members to improve patient health while respecting the planet. We activate multi-disciplinary teams drawn from our network to deliver environmental sustainability improvements across the value chain.

Technology Strategy

Technology Strategy acts as one voice of the industry to define strategy, accelerate technology transformation and support technology translation and adoption. With a purpose of enabling the future state of flexible, resilient, sustainable end-to-end biomanufacturing.

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Publications

Documents including best practices, vision statements and peer reviewed papers to help you take value back to your business.

Webinars

Discussing all aspects of the biopharmaceutical industry, from digitization and knowledge management to raw materials, supply chain, sustainability and more. Learn from the perspectives of those at the forefront of the industry.

Podcasts

BioPhorum Connect is our podcast series that keeps you up to date with the latest news and trends in the biopharmaceutical industry. From experienced professionals to thought leaders, these podcasts bring you the insights and perspectives of experts from around the world.

Tools

A variety of resources including design tools and user requirement specifications to help you improve and streamline your business processes.

Benchmarks and Surveys

Research conducted among the BioPhorum membership providing evidence to support change and identify best practice.

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Access a variety of free tools and papers and other resources designed to provide you with up-to-date information and insights to help you make informed decisions and maximize your success. Access our resources today and start making improving and streamlining your business processes.

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