The BP Commission is looking to appoint new professional members to a new group
Published 28 April 2025
The British Pharmacopoeia Commission (BPC) produces non-mandatory best practice guidance for the analysis of Advanced Therapy Medicinal Products (ATMPs). This guidance helps ensure that ATMPs meet regulatory requirements and are safe and effective for patients, while also promoting innovation and growth in the industry.
Within the coming weeks, the BPC is looking to appoint new professional members, with a strong understanding of genomic technologies, for a new group focussing on providing non-mandatory guidance for CRISPR Cas9 Off-target analysis. Members will be contributing to, and developing written best practice guidance on the selection and execution of these methods for all stages of drug development and should have current expertise in:
Essential Criteria
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Expertise in one or more of the following CRISPR Cas9 off-target analysis methods, including the use of control strategies and risk management programmes:
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- In silico tools - Cas-OFFinder and CHOPCHOP
- Cell free methods - DIG-seq , SITE-seq and CIRCLE-seq
- Cell culture methods - GUIDE-seq, BLESS/ BLISS and ChIP-Seq
- whole genome sequencingÂ
- In vivo methods - Discover-seq and GUIDE-tagÂ
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- Experience in Sample selection for off-target monitoring AND solid understanding of orthogonal assays and the ability to implement multiple validation methods to confirm off-target findings
- Employment (current or previous) by cell or gene therapy developer OR University/Health sector OR as a Qualified Person.
Desired Criteria
- Have a good understanding of existing guidelines and best practices related to genome editing.
- Have a working knowledge of handling whole genome data sets.
- Work in a collaborative, interdisciplinary environment with peers and be able to communicate effectively
- Excellent communication skills, both written and verbal, with experience in writing clear, actionable guidance for scientific audiences.
If you are interested in contributing to the group, please send your CV to biolstandards@mhra.gov.uk.
The closing date for expression of interest is midday on 19 May 2025
Click here for more information on and access to the previously published ATMP guidance by the BP.