HALIX offers development services and pilot studies to bring your product into clinical phase. We can support you in small scale production, analytical development, freeze-drying and upscaling
Small scale production for evaluation of technological capabilities, as well as small scale production of freeze-dried product for process or analytical evaluation are part of our offering.
Based upon the process you have developed, our experts can scale up the process to meet the needs of your TOX, clinical and even commercial batch sizes. HALIX produces in our scalable, completely disposable based production facility. We use the subsequent tech batches to ensure in a cost-effective and GMP compliant manner that your critical quality attributes are unchanged in the resulting scalable process.
There is a high demand for freeze-drying among companies who develop products with stability issues, or companies looking to extend shelf life for their products. HALIX can support you in development and improvement of a lyophilization (freeze drying) cycle for biopharmaceutical products to solve these challenges.
We have a lab-scale freeze-dryer (0,5m2) which is suitable for development activities. By performing runs with a small amount of material, with a lyophilization cycle proposed by our freeze-drying experts, we can design and/or optimize your lyophilization process. Importantly, our lab-scale and full scale lyophilizers are designed for seamless scale-up, allowing cycles developed on the lab-scale machine to be directly implemented for your clinical and commercial scale batches.
Depending on your requirements for analytical development we either perform testing in-house, or we outsource testing to contract labs.