Clinical Trial Manufacturing
Let us guide you through your clinical trial.
When manufacturing your investigational medicinal products, we inspire with our in-depth expertise and over 40 years of practical experience in the production of sterile parenteral in accordance with the highest quality standards.
We ensure that all the necessary steps for the production of your clinical batches and the release of active ingredients are completed on time and in top quality. Benefit from on-demand batch production thanks to small-format freeze dryers and flexible filling lines. This enables us to keep losses as low as possible.
Rely on a partner who will provide you with the information required for the IMPD/IND submission for phases I-III of your drug trial and release it within the EU.
Manufacture of sterile lyophilised and liquid dosage forms for small drug molecules and biologics, including:
- sterile filling
- Analytical service
- Stability testing
- QP certification
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Let our experienced team accompany you on your way to a successful investigational medicinal product. We convince with profitable ideas, clean processes and fast delivery times.
WITH PASSION FOR YOUR SUCCESS
OUR SOLUTIONS FOR YOUR CHALLENGES
Losses on the filling line become a major problem with very small quantities.
The substance was delivered by the client frozen in PP-bottles, was thawed and subsequently pooled into a small-scale pressure vessel in our compounding area. By using nitrogen pressure, <30mL of substance remained in the vessel. By using small-size sterile filters and flexible tubing, losses could be further minimized.
Finally, a filling machine with a single pump was used, further reducing losses in tubes and pumps compared to regular machines with multiple dosage-stations. By using the flushing volume to adjust the filling weight, the saved volumes meant significant additional product units. Losses between compounding and filling amounted to only 4%, meaning a 96% was available for the clinical trial.
APIs can be highly sensitive to UV light and degrade quickly
To protect the API, all UV light sources that could have an influence during the manufacturing process were identified. Sunlight penetration was prevented by using special UV filter films on all windows through which preparation or filling areas could be irradiated.
Measurements were also taken in each room to ensure that artificial light would not have a negative impact. Components that provide natural shielding, such as closed stainless steel containers and opaque pipes, were selected for handling the solution.
The product was successfully manufactured with zero indication of product degradation caused by UV light.
Client API is highly sensitive to temperature with degradation commencing within 30 minutes of temperatures over 10°C.
A proprietary technical solution was developed and implemented that holds the solution within the required temperature range during both compounding and filling. The temperature was continuously monitored using data-loggers throughout the fill & finish process and this data was made available to the client as part of the batch documentation.
Client required packaging solution for a blind, multi-centric study in different European countries (i.e. languages)
In addition to the patient medication kits, a further kit with supporting medical devices (syringes, filters, connectors etc.) was required. A unique packaging processes was developed for each kit and designed so that the client was able to order minimal / different quantities each of the medication / device kits in the same purchase order, enabling full flexibility for re-supply of the clinical trial sites.
To implement the packaging process, two employees received special training with supervision performed by the client’s project management team.