continuous downstream processing

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Bringing BioPhorum’s unique perspective to continuous manufacturing in biologics

Continuous manufacturing (CM) has been a goal for the pharmaceutical industry for several years. While small molecule drug substances and drug products have achieved this in many cases, biologics are behind the global implementation of CM because of their more complex manufacturing processes.  However, the regulatory agency members of the International Committee for Harmonization (ICH) now have enough experience in the registration,...

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Industry feedback on ICH harmonized guideline: Continuous manufacturing of drug substances and drug products Q13 draft version

A comprehensive response to ICH Continuous manufacturing of drug substances and drug products Q13 draft version. The BioPhorum team overall think the draft reads well and believes the concepts and ideas are aligned with BioPhorum thinking on continuous manufacturing for biologic drug substance and drug product.

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Why BioPhorum’s control plan is a blueprint for continuous bioprocessing success

BioPhorum’s Continuous downstream processing for biomanufacturing: an industry review published in 2019 outlined the technology and regulatory barriers in the continuous downstream processing of therapeutic proteins. The roadmap received great acclaim, especially because it identified several gaps in the process, including a lack of a control plan for continuous bioprocessing. To fill this gap, BioPhorum has published a technical white paper...

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A risk-based blueprint for process control of continuous bioprocessing

This paper gives an overview of an accompanying risk assessment template and acts as a blueprint for industry. It will be useful for any organization new to continuous bioprocessing, while experienced companies can use it to benchmark their existing operations.The blueprint will accelerate the realization of commercial continuous biomanufacturing processes and signals to regulators that this is the direction of industry travel, with a consensus view of how it should be done.The control plan will help lower the implementation barrier for starting continuous bioprocessing and provide a better understanding of its needs for end-users and potential vendors as it aligns and standardizes the industry’s validation approach.

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Removing the roadblocks to continuous biomanufacturing

Continuous downstream processing is increasingly seen as a feasible approach for manufacturing biologics. The industry recognises that it offers advantages over batch-based processing by: producing products with a more consistent quality attribute profile allowing greater flexibility to react to changes in market demands reducing up-front capital investment in facilities optimizing the cost of goods. However, despite these potential benefits,...

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Continuous downstream processing for biomanufacturing: an industry review

Anyone attempting to establish continuous downstream processing of therapeutic proteins will know that there are documentary gaps in technology and regulatory requirements. This industry review provides a gap analysis of a typical continuous mAb downstream process from primary capture to bulk drug substance. It does this to highlight the gaps that are preventing the use of continuous biomanufacturing with a goal of focusing industry and supplier efforts on generating solutions. These gaps are grouped into these categories covering, unit operation technologies, single-use technologies, automation, modeling and regulatory. The paper also defines common terminology to clarify their meaning. It is hoped that closing the gaps identified in this paper will turn the promise of continuous bioprocessing into a reality so that patients, biomanufacturers and suppliers may all benefit.

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