Host Cell Protein and Other Bioresidual Impurities

The primary goal of this workstream is industry alignment on detection, identification, risk assessment and Host Cell Proteins (HCPs) control strategies. However, the team also shares best practice and knowledge on other types of impurities such as aggregates. The goals of the workstream have been and will be achieved through benchmarking and building a gap analysis of guidance to create a common understanding of agency requirements.

Control of problematic host cell proteins and other impurities in biological processes and products

Identifying and confirming all HCPs which are present in a manufacturing process and the end products is critical to ensure patient safety. Areas of concern include development of a robust manufacturing process, which effectively removes potentially problematic levels and types of HCPs. The workstream concentrates the majority of its efforts on problematic/abundant HCPs, as well as HCP control and attempts to keep abreast of associated ever changing Health authority requirements / concerns.

Other types of product and process related impurities can also present business, regulatory or patient safety risks. Whilst these tyoes of impurities are not considered to be as problematic to remove from a process or product, knowledge sharing and industry alignment is also necessary.

Reducing regulatory risk and risk to patient

The workstream focuses on several perspectives: regulatory, patient, product quality and financial. It also considers how a risk control strategy impacts the change process. To maintain assay integrity throughout the lifecycle, data depends on critical reagents. If internal rework is conducted, timelines can be impacted. It is important to mitigate all risk (regulatory, patient, timelines, resources, etc.) through shared understanding, and development of a harmonized approach (which could potentially lead to influencing regulators or meeting their expectations).

This workstream also enables sharing recommendations for assays and critical reagents, their management, maintenance and best practice in bridging studies. Regulatory and patient risk is reduced and risks in subsequent clinical trials can be avoided based on experience and knowledge.

Host Cell Protein and Other Bioresidual Impurities deliverables

DeliverableDateDetailsDownload

Enzymatic activity assays – general usage assessment

2 November, 2022Member only

Characterization and risk assessment of host cell proteins using mass spectrometry

2 November, 2022Member only

Host cell protein risk assessment – Where we are with BioPhorum cross-company collaboration and what we have learnt from an industry perspective?

19 May, 2022Member only

“High-risk” host cell proteins (HCPs): A multi-company collaborative view

2 September, 2021Link

Host cell protein (HCP) : Benchmarking mass spectrometry standards for USP

11 March, 2019Member only

Host cell protein (HCP): Risk assessment tool and papers

25 June, 2018
1.32 MB
695 downloads

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