Bryan Thompson, Production Manager
Bryan has worked in a manufacturing capacity with Almac Clinical Services for the last 11 years. He is responsible for the development and management of 200+ staff across a three-shift clinical packaging operation. Bryan has the additional responsibility of overseeing the generation of a complex production schedule, review of Project specific generated batch documentation, and quotation generation.
At Almac, Bryan has gained extensive knowledge of the processes, equipment, and materials utilized in clinical trials packaging, and is a subject matter expert on cold room packaging.Contact us
Ask the expert
Ten minutes with Almac’s Bryan Thompson, Production Manager
The world of clinical trials is changing. With a shift to biologics and precision medicine, coupled with the growing demand for global clinical trials representing a more diverse patient demographic, there is a greater need for sponsors to operate clinical trials effectively to safeguard product integrity. While the benefits of this industry evolution are clear, the additional complexity of operating global trials involving high value, temperature-sensitive and/or personalized products intensifies the risk – to patients, to production and to program performance. However, CDMO’s like Almac are able to support sponsor companies to meet their deadlines, maintain budgets and deliver potential life-changing treatments to patient groups.
We’ve collated some frequently asked questions and took them to our in-house expert, Bryan Thompson.
So, sit back, relax and take ten minutes to check out Bryan’s expert insights…
What are some of the main factors to consider regarding clinical supply packaging?
Planning an effective packaging strategy for temperature-sensitive products means working around limitations and embracing innovative label design methods, materials and processes to overcome challenges. Sponsors should take account of critical factors including application and storage temperatures, package sizes and materials, as well as environmental factors.
Packaging strategy shouldn’t be limited to study drugs. It’s also vital to consider whether clinical trial material requires shipment of an ancillary kit too. If ancillaries, such as syringes, needles, swabs, sharps containers and IV bags, are a requirement, these need to be factored in at the earliest opportunity in order to avoid potential of disruption and delay.
How do temperature-sensitive products impact clinical packaging/labelling operations?
The emergence of biologics has turned clinical packaging and labeling on its head! Fragile dose formats and small containers can make label application problematic. As can the controlled processing conditions required to maintain compliance with a product’s stability requirements, which can alter the way adhesives behave and demand specialist, difficult-to-procure materials, novel operating practices and packaging design workarounds.
To add to the risk present during this critical stage in the cold chain, limited stock availability combined with high value products and primary packaging fragility significantly reduces the margin for error. This makes it crucial for sponsors to review a product’s specific set of processing requirements and potential impact on packaging and labeling activity during a trial’s planning phase. Once processing requirements are understood, specific parameters and protocols can be developed with the limitations of a specific temperature range in mind.
What production factors should be considered for temperature-sensitive biologics?
There are several factors to consider relating to how standard production methods and facilities – designed with traditional pharmaceuticals in mind – may need to adapt to meet specific needs of temperature-sensitive products. If time out of refrigeration is restricted or not permitted, adjustments will need to be made to maintain drug integrity. Sponsors may also need to accommodate longer packaging durations, reduced operation sizes and enhanced PPE for operatives.
Another factor to consider is manufacturing strategy. Batch manufacturing can reduce overheads for trials with predictable supply and demand patterns, but the shorter expiry dates associated with temperature-sensitive products can necessitate multiple updates of labeled inventory and lead to waste and/or excessive storage costs. Just in Time Manufacturing is another option, which is especially beneficial for trials that involve patient-centric dosing; helping to facilitate greater supply flexibility and cost control. Each supply scenario is different so it’s vital that requirements are scrutinized early so appropriate approaches can be selected.