After successful process validation, HAPILA synthesises active pharmaceutical ingredients under GMP conditions; with these ingredients drugs for clinical studies and supply to the market can be manufactured.
The analytical services required are also provided by HAPILA; on occasion qualified commissioned laboratories are used for specific requirements.
Release of the GMP pharmaceutical ingredients, as well as complete batch documentation including certificate of analysis (CoA) and certificate of conformity (CoC) are generated by HAPILA ensuring that our customers will receive all results from one source.
In addition to 2 GMP laboratories (10L / 30L scale) we have another 2 GMP- pilot plants for the synthesis of active pharmaceutical ingredients at our disposal (100L scale). All plants are qualified and suitable for handling highly active ingredients. We are able to realise advanced requirements regarding equipment in a short time.
By the spatial separation and by separate ventilation of all the labs and pilot plants we are able to perform different syntheses at the same time, including isolation, drying and packaging. A corresponding zonation black-grey-white is an essential basis to fulfil GMP formalities. The scale covered is between grams up to a 10 kg batch.
With our flexible decentralised cooling/heating supply system we are, depending on the demand, able to cover the temperature in the range of -90…+220°C at the same time.
At HAPILA qualified analytical equipment is available to perform identity tests and/or complete analyses of raw materials for incoming components inspection, in-process control, stability investigations as well as release analytics for intermediates and for pharmaceutical ingredients by different analytical methods:
- HPLC (DAD),
- GC including Headspace-GC (FID),
- Karl Fischer titration,
- Optical rotation,
- Refractive index,
- Loss on drying,
- Sulphated ash/Loss on ignition,
- Melting point,
- Determination of pH,
- Heavy metals (Ph. Eur. 2.4.8) and
- Visual inspections (form, color, turbidity etc.)
The release and stability analytics are performed with implemented monographed pharmacopoeia methods or according to ICH Q2 (R1) validated in-house methods.
Methods not established at HAPILA such as methods using atomic spectroscopy and particle size measures as well as microbiological determinations are secured by qualified and certified Partner laboratories on our behalf (e.g. Jesalis Pharma GmbH »» , Labor L+S AG »» , CUP Laboratorien Dr. Freitag GmbH »» ).
The reference substances required for analytical methods (APIs and impurities, also for syntheses not run at HAPILA) can also be manufactured and extensively characterised by HAPILA; the results are summarised in a certificate.
To isolate and purify reference substances, there is, in addition to flash chromatography, equipment for preparative HPLC available.
For the analytical assessment of the standard substances there are, in addition to the in-house methods mentioned above, further methods at partner laboratories at our disposal (such as NMR, MS, XRPD, DSC).
The entire management of reference substances is secured by HAPILA.