How will Just In Time Manufacturing really work?
Almac share how their full late stage customization of clinical supplies will put patient demand at the forefront of supply strategy
In June, Almac Clinical Services launched Almac Adapt™ a Just in Time Manufacturing (JTM) solution. With clinical trials facing aggressive study timelines, rising costs and a global spread of targeted populations, there is a growing need to adopt flexible supply solutions.
In this interview Natalie Balanovsky, JIT Manufacturing Solutions Manager, shares how Almac’s JTM solution will work in practice, how the industry can carry a just in time mind-set throughout the supply chain and the drivers behind this development.
Pharma IQ: What are some of the key drivers behind this development?
Natalie: Well, Just in Time Manufacturing has been a concept Almac has been developing over the past few years.
Certainly, from working with our sponsors and listening to their challenges and needs, we recognised that this was a model that would be very useful for their supply chain challenges.
Biologics, in essence, are very expensive to produce and stability is short, so trying to assign an expiration date well in advance of a traditional manufacturing operation is challenging to say the least.
Other driving factors such as working within conditions to preserve inventory, creating a patient centric approach and being able to act on any change management in a timely and rapid fashion have pushed us towards an operational model like this.
Pharma IQ: Can you explain how this process will work in practice?
Natalie: Almac Adapt is a full late stage customization of clinical supplies by postponing packaging and labelling until the site or patient need arises.
So the sponsor sends their bulk material to us, typically in an unlabelled format. While that material is being forwarded, the sponsor will be working with the project team to coordinate pre-production efforts, including creation of master documents to perform future JTM operations. Master documents include label proofs per country, assembly instructions per kit type and any unique production notes necessary to perform operations. All of these master documents become the reference guide, if you will, for when the actual material is needed.
By postponing packaging and labelling until the site or patient need arises, you can put patient centricity at the forefront of your clinical supply strategy
When a need arises at the site, an order is raised and received at the appropriate Almac location that will be processing the JTM operation. All of the information on the drug order is validated against our pre-production set up and all masters. If everything is validated then we submit the order to manufacturing.
Then, labels specific to that order are printed in the country’s language, as we are making supplies for a specific site and specific country.
Once the labels are reviewed and approved by our quality team, the actual kit assembly commences. Our JTM team issues all approved labels and materials, and follows the master documents with full QC oversight.
When the material is approved, it leaves the room in a quarantined status. At this point, a quality auditor and QP if applicable reviews the final record. And if everything is agreeable it gets signed off and released into our ERP system. It’s at this point that our distribution team can complete the distribution order and dispatch completed clinical kits to the requesting site. All within just 5 business days.
Pharma IQ: Are we likely to see further innovations in this field?
Natasha: Yes, I believe so. With the population rapidly growing and aging, the need to be patient centric is becoming increasingly important and we have been developing patient centric strategies for the past number of years.
I’m sure there’s going to be more iterations of this, with companies trying to become more innovative and also trying to deal with a lot more constraints.
Pharma IQ: Where do you think the industry will begin to focus next?
Natalie: If a sponsor is seeking to leverage the full scope of a Just In Time approach, it is critical that it’s not just being applied in one facet. In the long run, if sponsors take on-board the entire mind-set across the supply chain and think with a just-in-time approach they could achieve even greater benefits when applied both upstream and downstream.