Clinical Trial Manufacturing (CTM)

With its specialized know-how in parenterals, BAG is your partner from preclinical phase through phase III into commercial supply. BAG has over 40 years of experience in sterile parenteral manufacturing in accordance with the highest quality standards. Our facility located in Lich, Germany is approved by EMA, ANVISA and several other MHAs. FDA approval is currently in preparation.

Our clinical manufacturing know-how and focus on time-to-clinic can streamline your path to clinical trials. With dedicated project management we provide the confidence that all the necessary steps for clinical batch production and release of your compound are completed on time. We provide early-phase clinical trial manufacturing for a broad range of vials and ampoules. Small freeze dryers and flexible filling lines mean we can provide batch sizes depending on your specific needs and requirements and minimize losses at the same time.

Our manufacturing services for clinical phase I-IlI include:

  • compounding
  • sterile filtration
  • preparation of primary packaging materials
  • aseptic filling
  • lyophilization
  • visual inspection
  • stability testing
  • labeling
  • packaging
  • shipping

For both biologics and small molecules, our experts help overcome [early] formulation challenges and develop and manufacture early-phase clinical materials. BAG generates the data required for IMPD/IND filings and releases your product for your clinical trials.

Learn more here in our Case Studies!

1. Fill & finish of very small bulk volumes (<2,5L)

Problem: Line losses become onerous when working with very small bulk volumes.

Solution: 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.

2. Fill & finish of highly sensitive drug products (e.g.UV/light/oxygen)

Problem: APIs can be highly sensitive to UV light and degrade quickly

Solution: To adequately protect the API, all potential sources for UV light during the manufacturing process were compiled. Sunlight from the outside was then blocked by installing special UV-filtering foils on all windows that could potentially pass sunlight to the compounding or filling areas. Within the individual rooms, special measurements were taken to ensure that artificial lighting would not have a detrimental impact on the API. Only such equipment was chosen that provides natural protection, e.g. closed stainless-steel vessels and opaque tubes. The product was successfully manufactured with zero indication of product degradation caused by UV light.

3. Fill & finish with specific temperature parameters (cooling during manufacture / filling)

Problem: Client API is highly sensitive to temperature with degradation commencing within 30 minutes of temperatures over 10°C.

Solution: 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.

4. Development and implementation of a complex packaging solution

Problem: Client required packaging solution for a blind, multi-centric study in different European countries (i.e. languages)

Solution: 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.