Phase I (Understanding the Start-Up)
Due to the sensitivity and non-disclosure agreement with the start up pharmaceutical organisation the case study cannot use specific business names.
- Enquiry came through to the Origin NPD team, explaining they are brand new, start-up pharmaceutical manufacturing business and have no packaging team/ department and need full, holistic support, guidance and management of their packaging supply chain (building from the ground up)
- Targeting generic (plus) – manufacturing generics, but speciality drugs – liquid format
- Work in partnership with Origin Pharma Packaging to discover the best packaging formations for the range of products they were developing
- What market was their product destined for, commercially?
- 2000 bottles plus common closure for all (500 pieces) – development phase
- Same equipment to cap the bottles
- Moved at a quicker pace and a wider portfolio of product
- Exploiting a niche market in the UK
Phase II (Development Stage)
- Monthly meeting to find out where they were going with their project and to ensure their packaging supply chain was being set up in accordance with their drug development phases
- To understand and answer their immediate project (development stage)
- We become the ‘Packaging Director’ and guide them as to what packaging they would need to go, if they went commercial (often start up, select the wrong product in the initial stages, when wouldn’t work for the commercial stages)
- Helping them to understand the long-term of their product and selecting the right packaging (design) to ensure no unnecessary cost are incurred with the drug goes to commercial
- What regulatory hurdles are they going to be facing in the future?
- Where it is being manufactured, the project director where the bottle will be designed/ produced – strategically selected to be near the drug manufacturing facility
- Where will they be commercially manufacturing the drug?
- Special project: Bespoke measuring beaker, they needed a different capacity and graduation markings – designed from scratch/ Best technology and learns from other product to fit succinctly (CE Mark Registration) – medical device)
Phase III (Delivery Stage)
- Proposed product specification – and match, phase of sampling, will this fit the machinery? Will it work for initial development studies?
- Once bottles and closures have been selected and design, the traction pf the packaging development begins to build momentum
- Upfront investment of time and energy, both parties – necessary, sizable investment, to gain traction within a new project (Origin Pharma are experienced in supporting/ collaborating with new start-up pharmaceutical manufacturers, we recognise this).
- Inventory management to support the early, low volume quantities stages (stability, testing, validation batches, exhibition batches)
Gave the start-up opportunity to come back to refine the design, so that it passes regulatory
- Ready to support the scale-up programme
- Each project goes through a similar cycle, heavily weights in the initial stages of a start-up project and comes to a slow curve and then ramps up as the drug development launched into commercial stage