Editorial | Open Access | Published 20th December 2021

GUEST EDITORIAL : Skills to meet the future challenges in Pharma/ Biopharma and ATMP manufacturing

Authors : James Drinkwater F Ziel Head of GMP compliance. PHSS Lead in Aseptic processing special interest group

Adam Bird; Director & Deputy Head of Quality Oxford Biomedica (UK) Ltd. PHSS Co-Vice Chair

As new products are developed, new technologies evolve to meet any new manufacturing requirements, but key to successful implementation in meeting GMP requirements with the required level of product quality, efficacy and patient safety are the skill sets in personnel with knowledge to support such advances.

There is increasing concern that there will be a shortage of skills sets in the future to support advances in product processing and supporting technology implementation as we move towards a paradigm shift in types of products manufactured e.g., fewer big blockbusters, more biologically based targeted personalised medicines and therapies produced aseptically in smaller batches.

Skills are being lost as Subject Matter Experts (SME) leave the industry or retire, with retention of in-house knowledge key to sustainability of production processing.

Contracted–in skills are increasingly challenged as demand becomes higher from biotech/ ATMP processing companies to support science with compliance as products advance from development into commercialisation. The scientific skill sets have not necessarily had the same educational exposure to good manufacturing practice (GMP) and rely on support from those experienced in GMP. Biotech companies are recruiting team members with skills in GMP manufacturing to work alongside scientists and specialists, but increasingly these resources are becoming difficult to acquire.

All skills have a knowledge base and it is this essential knowledge that needs to be established, applied and retained together with succession planning to assure continuity.

Also essential knowledge transfer is required to retain knowledge in-house from contracted-in personnel (that may have short term contracts, or simply decide to move on) and from specialists in technology platforms that form part of product manufacturing and associated control and monitoring within GMP compliant operations.

Establishing a base of SMEs to support a process and GMP compliance is essential, with training the foundation to knowledge transfer.

In GMP, the principle of Quality Risk Management (QRM) is well established (and further encouraged in the revised EU GMP Annex 1). Managing risks starts with risk identification that is supported by essential process knowledge.

More and more automation is being used in Pharma/Biopharma/ATMP product manufacturing, with increased separation of personnel from processes to control contamination, usually via implementation of barrier technologies. In addition, smaller batch sizes support strategies for manufacturing with extensive use of single use systems and pre-sterilised containers, in essence contracting out extensive sterilisation activities. Automation and outsourcing can create a disconnection between personnel and essential process knowledge, placing more challenge on GMP compliance following QRM principles; know your process, know the risks, control and mitigate risks.

Increasingly new product processing is completed via aseptic processing, whereby the SME usually lead the design, implementation, qualification, and training. All aspects of facility, process design and production operations need skill sets and knowledge transfer to assure essential knowledge is in-house.

In aseptic processing, specific training is required to support GMP requirements including: good cleanroom behaviour, aseptic process training via aseptic process simulations with associated training in aseptic technique to assure contamination control measures meet requirements. EU GMP Annex 1 (revised draft) defines an attitude or ‘Mind-set’ that all require to support contamination control and building this mind-set into the company quality culture will be key to GMP compliance and assurance of sterility.

With the expected skill shortage, all companies need to consider how to avoid such challenges and impact of skill and knowledge loss. Establishing a base of SMEs becomes critical with training plans which are key to implementation and knowledge transfer. Recent analysis of the existing and future skills capacities in UK Cell and Gene Therapy (https://ct.catapult.org.uk/publication/uk-cell-and-gene-therapy-skills-demand-report-2021) indicates that there is a significant risk in terms of the available skill sets to support expected industry growth in the UK for Cell and Gene Therapy, particularly in Manufacturing and Quality functions. Once SMEs and knowledge are established it will be then contingent to complete succession planning to manage risks of skill-knowledge gaps developing in the future.