By HAPILA GmbH
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HAPILA GMP focused API contract development and manufacturing
HAPILA GmbH offers a suite of sophisticated capabilities that can be used to complete GMP manufacturing for sophisticated drug substances, including hard to handle highly active pharmaceutical ingredients (HAPIs).
HAPILA’s certified Good Manufacturing Practice compliant (cGMP) plants can perform all contract development and optimization works, including particle design, synthesis, purification and scale-up activities required to establish a fully GMP certified manufacturing process for APIs and Intermediate, both for new substances and those already available on the market.
Step-by-step GMP process
Synthesis development for API with planned GMP manufacture starts with literature and patent evaluation. Following successful feasibility tests, step-by-step development operations include the necessary regulatory activities to obtain early-stage data.
From the outset of the process, HAPILA development work focuses on the accumulation of knowledge in order to create a firm footing for the subsequent steps of value-creation and cGMP manufacture to meet all the requirements of US FDA and EU GMP guidelines
Validation for cGMP approval
GMP compliance validity is based on prior successful completion of process validation, cleaning validation and validation of analytical methods. This includes collating all required analytical and stability data, reports and regulatory relevant documents, again in fully compliant formats.
Based on the development works, GMP manufacturing processes must be established in qualified plants with formal validation of process steps and analytical methods required.
HAPILA can generate complete cGMP documentation for the manufactured pharmaceutical ingredients, including complete batch documentation, certificate of analysis (CoA) and certificate of conformity (CoC) to ensure the customer receives all results from one source.
Following successful process validation, HAPILA can synthesize APIs under GMP conditions. This is much more than a basic contract manufacturing organisation process; with analytical services required provided by qualified in-house laboratories where necessary.
Successful chemical synthesis is based on HAPILA’s three main core capabilities:
- Sophisticated Technical Facilities: GMP pharmaceutical laboratories at 10L and 30L scale as well as a further two GMP-pilot plants for synthesizing active pharmaceutical ingredients (APIs) at 100L scale, with all plants qualified and suitable for handling highly potent active ingredients (HPAPIs). Spatial separation and separate ventilation of all labs and pilot plants allows HAPILA to perform different syntheses simultaneously, including isolation, drying and packaging, with corresponding black-grey-white zoning that is essential to fulfil GMP compliance.
- Full analytics: HAPILA’s 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 using the full range of analytical methods including HPLC, UHPLC, GC including Headspace-GC, TLC, IR, UV-VIS, Karl Fischer titration, optical rotation, refractive index, particle size distribution, loss on drying, sulphated ash/loss on ignition, melting point, pH determination, conductivity, and heavy metals. Release and stability analytics are performed with implemented monographed pharmacopoeia methods or according to ICH Q2 (R1) validated methods.
- Management of reference standard substances: HAPILA secures the entire management of reference substances required for analytical methods with results fully certificated. Flash chromatography and preparative HPLC equipment are available to isolate and purify reference substances. In-house or at partner laboratories can perform analytical assessment of standard substances using specialist techniques including NMR, MS, XRPD and DSC.
Scale up and technical transfer
If necessary, transfer of the processes to respective specially designed plants is done. Based on subsequent process validation, HAPILA can perform GMP processes for a reproducible production of the required API at pilot scale.
In accordance with its advanced CDMO responsibilities, HAPILA offers in-house GMP provision in addition to complete development up to scale-up, with process transfer available to customer.
Click on HAPILA Chemical Synthesis for more information.
Click on HAPILA Good Manufacturing Practice (GMP) Certification for further details.
Click on HAPILA Quality Management Systems to learn more.