By HAPILA GmbH
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HAPILA Substance Purification
HAPILA GmbH offers its customers a range of practical solutions for development and cGMP production of sophisticated drug substances. These development services include chemical synthesis, particle design and purification of drug substances.
HAPILA purification of pharmaceutical ingredients and intermediates as well as fine chemicals is based on extensive know-how in the evaluation, development and optimization of crystallization processes.
These substance purification capabilities and technologies are enhanced through HAPILA’s long-term cooperation with MPI Magdeburg (Max Plank Institute for Dynamics of Complex Technical Systems, Department of Physical and Chemical Foundations of Process Engineering), and with Jesalis Pharma GmbH. Both partnerships have opened up new avenues for demanding separation and purification processes, using crystallization.
HAPILA can apply its know-how which stands behind the patented HAPIpur® technology to optimize the crystallization process in batch processing or, if required, develop a process that tailored to specific substance and process, taking account of the depletion characteristics of targeted impurities.
HAPIpur® allows researchers to investigate the influence of different process parameters on the crystallization progression by computer simulation to enable HAPILA to offer cost-efficient process development.
As for distillation and extraction processes, it is also possible to run crystallization by continuously separating and combining the phases in a counter current process, utilizing the multiplication of separation effects based on the dispersion balance.
Here the essential requirement is to influence the supersaturation of the solution and the grain growth to achieve not just a coarse crystalline structure that is easily separable but also maximal and reproducible depletion of impurities.
Technological implementation has previously been significantly more difficult with crystallization because the phase transformation is a solid to liquid transfer. This has made it problematic to establish continuous counter current processes for crystallization of solutions as standard processes.
The multistage HAPIpur® process for counter current crystallization overcomes this obstacle in a compact plant, enabling a cost-efficient approach to the purification of solid chemical substances and, in particular, pharmaceutical ingredients. In comparison to other purification processes, such as batch crystallization or chromatography, the HAPIpur® technology offers significantly higher space-time yields.
This procedure is adapted to each specific purification task and sets new standards for cost efficiency and reproducibility both in pilot plant and production scale.
HAPILA purification processes can be developed and delivered in step-by-step form to minimize risks for both parties.
In the quasi-continuous crystallization process, the crystallized material and the mother liquor are handled in a counter current process without any external operation. All transfers take place (favorably) in solution. The solution and crystallization processes in the crystallizers are carried out in parallel and are time-synchronized – all resulting in a highly efficient process. Supersaturation during crystallization is adjusted by alternating heat and evaporation phases under vacuum for all concurrent and identical crystallizers. The growth in high purity of the crystals is supported by the oscillating temperature profile preventing the substance from sticking to the heater surface.
This results in excellent reproducibility of both purification as well as superior yields in all phases of the crystallization process. In so doing, considerable steps for a successful process validation are achieved.
The HAPIpur® process thus offers a number of tangible and definable benefits:
- Achieving simultaneously extremely high purity with higher yield
- Fast process development as well as a simple scale-up by a universally applicable system concept
- Cost-efficient operation by full automation
- Exact process calculation for reproducible results
- Low substance amounts required for development
- All processes undertaken on-site with no external manufacturing – ideal for cGMP production of highly potent HPAIs and HPAPIs
- End-to-end service from feasibility up to pilot-scale production
- Process / industrial scale equipment can be established at client sites through separate agreement involving HAPILA – Büchi