Multi-Product Facility

This workstream is creating best practices for the changeover and cleaning of multi-product facilities by developing technological improvements and standard processes to increase productivity, maintain compliance, and conserve resources.

Process revalidation reduces available manufacturing time

The team has been addressing hot topics relating to cleaning practices to align the industry and provide justification and supporting rationale for when cleaning validation is/is not required.

Increasing flexibility in the re-use of Protein A resin across multiple products within clinical manufacturing

Dedication of protein A resin to a single product for clinical manufacture creates high material costs, increased turnaround time between products, and logistical problems with resin storage and testing. This is due to the frequency and/or volume of clinical supply being lower compared to a commercial process.

In collaboration with the University of Limerick, the team is developing a standard risk assessment to identify potential carryover risk and supporting data/case studies to enable greater flexibility in the use of this material.

Multi-Product Facility deliverables

DeliverableDateDetailsDownload

Droplets vs dryness and the requirement for equipment post-cleaning

19 June, 2023
347.58 KB
455 downloads

Risk-based strategies to support revalidation and the assessment of requirements to maintain the validated state of equipment, process and facilities used for commercial and clinical manufacturing

23 September, 2022
256.55 KB
368 downloads

Product changeovers (PCO): Guidelines for risk based changeover of biopharmaceutical multi-product facilities

30 July, 2019
4.06 MB
299 downloads

Product changeovers (PCO): Justification for minimizing the removal of elastomers to prevent cross contamination in a multi-product facility

30 July, 2018
446.20 KB
149 downloads

Product changeovers (PCO): Methodology for assessing product inactivation during cleaning part II: setting acceptance limits of biopharmaceutical product carryover for equipment cleaning

19 December, 2013
807.65 KB
136 downloads

Closed systems: New challenges to the cleanroom paradigm for multi-product facilities

1 May, 2013Link

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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An industry perspective on understanding AAV capsid content variants
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An intercompany perspective on practical experiences of predicting, optimizing and analyzing high concentration biologic therapeutic formulations
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The Drug Substance 2.0 Strategic Value Framework
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BioPhorum’s holistic approach to container closure integrity
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Digital Plant Maturity Model 3.0
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Inaugural BioPhorum Quality face to face – get involved
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The next step in building regulatory as a capability to enable strategic innovation across the BioPhorum community
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Delivering a Cell and Gene Therapy Outbound Supply Chain Pathway for the Industry
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A vision for the biopharmaceutical industry’s inbound supply chain
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A major milestone – a harmonized approach to product carbon footprint data
Technology Roadmap V 2.0
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BioPhorum Technology Roadmapping roadmap vision 2.0

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.

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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.

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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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Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
WEBINAR
Bioreactivity testing in single-use system biomanufacturing
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Digital Plant Maturity Model 3.0
WEBINAR
Bioreactivity testing in single-use system biomanufacturing