By HAPILA GmbH
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HAPILA API pharma manufacture
HAPILA GmbH offers a comprehensive suite of range of practical solutions for API pharma manufacturing to GMP standards.
From synthesis and purification technologies up to scale up development to manufacturing scale, HAPILA offers solutions at every stage of the active pharma value chain for drug substances.
The pharmaceutical ingredients synthesized, purified or morphology designed particles via a physical shaping process (e.g. micronization, micro crystallization, spray drying etc), all under GMP conditions, are ready for deployment by customers for the manufacture of pharmaceutical products which are provided for the supply of clinical studies and the supply of the market.
Active pharmaceutical ingredient manufacturer
As one of Europe’s innovative active pharmaceutical ingredient companies HAPILA embraces four key specialist disciplines: synthesis, purification, analytics and particle design.
HAPILA can undertake the end-to-end development required for a wide range of active pharma ingredients, including the necessary scale-up activities, to establish corresponding GMP manufacturing processes in fully qualified plants.
Compliance is confirmed after successful completion of validation of process, cleaning and analytical methods.
After successful process validation, HAPILA is able to synthesize pharmaceutical active ingredients for GMP manufacture; ready for clinical studies or supply to regulated markets. Furthermore, HAPILA has over 12 years of experience in the synthesis of analytical standards and impurities.
HAPILA’s technical facilities include two GMP laboratories at 10 l to 30 l scale, along with twin 100 l scale GMP pilot plants for synthesizing APIs with several more to come. All HAPILA plants are qualified and suitable for handling highly active pharmaceutical ingredients.
Spatial separation and separate ventilation of all labs and pilot plants is used to enable different syntheses simultaneously, including isolation, drying and packaging, with the black-grey-white zoning demanded by GMP guidelines. A flexible decentralized cooling/heating system allows HAPILA to simultaneously maintain a wide range of synthesis temperatures range from -90 °C to 220 °C.
At HAPILA site, two laboratories are dedicated to research and development. Beginning with first synthesis based on literature research, optimization of established processes and scale up from lab scale (several ml) to batch synthesis (1 l to 10 l) takes place.
HAPILA offers either complete development up to full-scale production or process transfer to customer for manufacture elsewhere.
Proprietary HAPIpur® technology, allows active pharmaceutical ingredients to be obtained at a very high purity and extraordinarily high yield. The technology delivers powerful advantages such as fully GMP validable continuous and automatable processes allowing precise planning using computer simulation, the on-site processing required for difficult to handle highly active or potent pharmaceutical ingredients (HPAPIs) and allowing processes to be performed on smaller crystallizers than those demanded for common batch crystallization. Other HAPIpur® advantages include safe reproducibility, lower thermic stresses and simpler scale up from laboratory to full production scale at up to 100 l batches.
HAPILA can also supply the analytical services required for validation of synthesis and can generate complete batch documentation including certificate of analysis (CoA) and certificate of conformity (CoC) to allow release of a GMP active ingredient, ensuring customers receive all results from one source.
HAPILA has qualified analytical equipment 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, including HPLC and UHPLC (incl. DAD), headspace-GC (FID), TLC, IR, UV-VIS, Karl Fischer titration, Optical rotation, refractive index, Loss on drying or ignition, melting point, pH determination, conductivity, particle size distribution and visual inspections for form, color, turbidity, etc.
Release and stability analytics are performed with implemented monographed pharmacopoeia methods or according to ICH Q2 (R1) validated in-house methods.
HAPILA also secures the entire management of reference substances required for analytical methods for APIs and impurities, if necessary including their syntheses run at one of HAPILA’s specialist partner laboratories.
From the outset, particle design and engineering focuses on the accumulation of knowledge in order to create a firm footing for the subsequent steps of value-creation and GMP manufacture.
Starting with literature and patent evaluation and following successful feasibility tests, HAPILA’s step-by-step particle engineering and development operations include the necessary regulatory activities to obtain early-stage data and information.
HAPILA can perform GMP processes for reproducible production of required particle structures in controlled clean room environment, based on successful transfer of process underpinned by continuous process management and subsequent process validation.
These processes can involve several stages, including taking of samples and product isolation as well as packaging to Class D clean room standards.
The HAPILA approach allows the laboratory to cover a wide range of reaction types, categories of substances, physico-chemical processes and accompanying analytical services.
Desired project objectives can include future GMP process undertaken at HAPILA or their transfer to another production location.
With over 12 years of experience in synthesis, purification, analysis and particle design of active pharmaceutical ingredients, HAPILA is partner of choice for several companies worldwide and delivers customized and innovative solutions.