DDW Editor Reece Armstrong speaks to Peter Walters, Director Advanced Therapies, CRB, and Grace Linton, Director Process Architecture, CRB about automation within laboratory settings and its effect on the pharmaceutical industry.
RA: How are labs utilising automated systems in regard to personalised medicines?
PW: Process development and pilot labs are seeing flexible, adaptable, and automated platforms for cell therapies or smaller scale gene therapies. These automated platforms enable companies to develop emerging therapies into platformed processes which are more commercially facing.
GL: Historically, manufacturing labs represent a more automated process than what is seen in pilot and development labs, since the manufacturing methods are more finalised, predictable, and more consistently performed by definition. However, in the cell and gene therapy space, some of the legacy processes are more manually performed using lower technologies which were available at the time of their commercialisation. As a result, many of the manufacturing labs are actually using less automation than some of the newer more modern pilot and development labs we are seeing built today.
Quality control labs are seeing use of more automated testing systems, which are allowing staff to prep and run far more tests efficiently, consistently, and without direct personnel oversight. This allows staff to multitask and perform more content through their day. These systems are enabling a more densified testing footprint within the lab space.
RA: Are automated systems at risk of putting lab technicians/personnel out of work, or can they enable other areas of work to be focused on?
PW: At the moment, the cell and gene therapy sector is understaffed. The industry is in desperate need of highly technical and skilled labor, that automation is enabling companies to perform more, rather than directly reducing staffing. Automation in this case allows companies’ labor force to focus on the most productive and purposeful tasks, as opposed to the repetitive complex tasks that could be handled by automated technologies.
RA: For biotech/biopharma companies, what are some of the key challenges they face when implementing automated systems in their labs?
PW: In our most recent 2022 Horizons report, our survey respondents identified cost, organisational reluctance, and lack of skills as being the top challenges to implementing digital infrastructure. One thing to consider is that changing to a much more automated facility directly impacts multiple departments. There may be significant disruptions to their existing workflows and day-to-day operations as these systems get implemented, and as a result this may actually generate reluctance to update. While companies may find it easier in the short term to maintain the status quo, proper planning and implementation of more optimised processes should ultimately yield a more effective and efficient business.
RA: Can you discuss some of the QC and headcount challenges/issues that arise when using traditional means of lab testing for personalised medicines?
GL: When it comes to personalised medicines, every batch is dedicated to a single individual patient. As a result, the dose for every treated patient must individually undergo the full series of quality control testing, including final release testing. As companies look to scale out their operations to serve greater patient populations, the QC space must also scale out in turn. This can result in significant footprint, testing costs, and labour requirements. There can be issues for these companies with regard to staff training, consistent performance across procedures, and magnitude of workspace.
PW: Especially for personalised therapies, the control and handling of the samples must be carefully monitored and proceduralised. Automated systems can significantly reduce the opportunities for mix ups and human based errors in sample logistics.
RA: What advice would you give to companies thinking about implementing automated systems?
PW: While it may seem like a daunting endeavour, the earlier companies plan for and implement digital infrastructure, the better off they will be. It will be much harder to upset and upgrade an existing practice than to begin with a digitised one. Companies should also be aware that some of these more Pharma 4.0 initiatives can have significant lead times for actualising.
RA: Are there any regulatory changes you’d like to see to help increase the uptake of automation across pharma?
GL: Use of automated systems for manufacturing typically goes hand in hand with the use of inline and online analytics, which tend to enable a more robust process and a better documented quality system. These are all things that regulatory agencies around the world are pushing for, as the biopharma industry begins its shift toward Pharma 4.0. Across all lab spaces, automated technologies help drive consistency, thereby enabling quality by design across all aspects of manufacturing and testing.
PW: We are encouraged by seeing the push for closed, automated systems in the production and testing to support personalised medicines, as they help remove the human from the process and drive quality at an equipment level.
Regulations should encourage and incentivise companies to leverage more automated technologies to help look toward a more commercial facing future for cell and gene therapies, while not being too prescriptive or oppressive to the point of stifling innovation and preventing new therapies from being able to reach their intended patients.
DDW Volume 24 – Issue 1, Winter 2022/2023
Biographies
As a lead process architect for designing Current Good Manufacturing Practice (CGMP) biopharmaceutical facilities, Grace Linton is responsible for integrating the client’s goals and programming criteria, regulatory requirements, and building codes and standards into a cohesive facility concept. She has delivered projects covering a range of facility types, including monoclonal antibodies, vaccines, oligonucleotides, and cell and gene therapies.
Peter Walters is a process engineer with 18 years of experience specialising in pharmaceutical process and facility design. He has designed equipment and processes for the multi-step manufacturing of pharmaceutical drug products, performed scale-up of aseptic bulk process to various capacities, and product manufacturing for clinical studies in Phases I, II, and III.
