As large molecule manufacturing grows, the biopharma industry in Britain is reporting “major skills gaps,” especially in maths and computing, which must be rectified to keep manufacturing going, says a report from the Association of the British Pharmaceutical Industry.
ABPI speculated this gap is probably due to the relatively small number of trained and experienced people who currently work in this sector, with increased driven by rapid development of biotechnology outstripping supply.
By contrast, small molecule API manufacturing in the UK has declined in recent years as companies have outsourced production or built facilities abroad, it said.
“This has reduced the size of the UK workforce in this area, making it harder to find skilled and experienced people. This is likely to be exacerbated in the short term as some companies seek to increase their activities in this area in the UK over the next few years.”
A survey conducted by the Medicines Manufacturing Industry Partnership (MMIP) – a joint effort by ABPI and the BioIndustry Association (BIA) – found that while MSc graduates are the biggest need within general drug production, biomanufacturers’ biggest concern was the lack of PhD candidates needed for vaccines, and clinical trial manufacturing.
Within quality operations, the survey identified validation skills as a “significant gap” and statistics knowhow as another area of concern.
Process engineering skills, especially those required for process development and scale-up, are seen as an important issue, as is experience with sterile product manufacture and aseptic processing.
Manufacturing top priority areas: the percentage of respondents rating each manufacturing top priority discipline as high/medium/low priority/‘not a problem’ (Image: ABPI)
The Quality problem
Within quality operations, validation skills were identified as a major gap. The largest problems occurred in emerging areas, such as validation for Quality by Design (QbD) programmes, computer systems validation, and cleaning validation (given the recently revised EU guidelines for health-based cleaning criteria).
Analytics training is seen as important for biologics manufacture for data analysis, and respondents were concerned about meeting future needs as this sector grows.
ABPI called for its own expert network groups and the Medicines Manufacturing Industry Partnership (MMIP) Skills group to monitor “critical disciplines” in their areas and raise concerns when it becomes more difficult to recruit people with the skills required or when new needs are identified.
ABPI also said the Science Industry Partnership (SIP), research councils, and professional bodies should monitor industry concerns about professional skills.
It singled out maths especially as an important subject for biopharmaceutical employees and said the country should encourage students to study maths alongside science subjects after the age of 16, and to put more emphasis on maths in bioscience courses, and to increase the number of Masters and PhD graduates with related training in statistics, data mining, mathematical modelling and related disciplines.