By HAPILA GmbH
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HAPILA GmbH is a Contract developer and manufacturer (CDMO) that provides high-value services to pharma, biotech and fine chemicals client companies in the development and cGMP manufacture of active pharmaceutical ingredients (APIs).
HAPILA supports the development and manufacture of drug products with patented processes and in-depth experience in the API value-creation chain from synthesis through purification to particle design.
The company’s mission is to supply exclusive products of highest quality, potency and safety in compliance with GMP and environmental protection guidelines. All HAPILA teamwork is focused on product quality and customer satisfaction.
HAPILA’s three major business areas: synthesis, purification and particle design cover the complete API value-creation chain, enabling it to be a highly efficient bridge-builder between API production and pharmaceutical end-use.
All HAPILA APIs are manufactured in-house at its GMP certified facility at Gera, Thuringia, in east-central Germany.
In addition to API manufacturing, HAPILA GmbH provides independent development and scale up of chemical API synthesis including analytical method development, manufacturing of reference substances and development of purification processes based on its patented HAPIpur® technology that fully automates continuous counter current crystallization.
HAPILA can also provide regulatory support with relevant documentation like ASMF, CEP and IMPD (Drug substance part).
HAPILA can provide exclusive synthesis, process development and GMP manufacture in several labs and pilot plants up to 100 L scale for a wide range of high value drug substances such as steroids (e.g. Estriol), amino acids, etc.
HAPILA has three main areas of capability:
HAPILA can synthesize pharmaceutical ingredients and excipients including development of analytical methods and multistage synthesis processes to manufacture highly active ingredients including the creation of the required analytical and stability data, reports and regulatorily relevant documents. HAPILA can also optimize existing processes as well as test and realize alternative synthesis routes.
HAPILA’s synthesis services also include developing new syntheses to manufacture APIs and Intermediates, innovative synthesis design for new and existing substances, generating feasibility studies on the synthesis based on intensive investigations in literature and patents, handling of highly active substances, scale-up of synthesis processes and process transfers to external production plants.
These services cover a wide range of substance classes including steroidanalogues, amino acids, flavones, porphins and benzothiazinones.
HAPILA has developed leading-edge purification procedures that use advanced crystallization techniques to combine high yield with highest purity.
HAPILA has particular expertise in the evaluation, development and optimization of crystallization processes for the purification of pharmaceutical ingredients and intermediates as well as fine chemicals, opening up new prospects for demanding separation processes by crystallization in partnership with the Max Plank Institute (MPI) for Dynamics of Complex Technical Systems, at University of Magdeburg.
Based on the relationship specific to substance and process with regard to the depletion behaviour of impurities, HAPILA can optimize the crystallization process in batch processing or, if required, develop a process using its patented HAPIpur® technology for continuous counter current crystallization that provides a more efficient alternative to batch crystallization or chromatography.
Customized chemical and particle design
HAPILA has in-depth expertise in the fields of chemical design and particle engineering, to create an extensive portfolio of technologies for physical conditioning, focusing on optimal bioavailability of ingredients and optimized galenic processing to suit customer requirements.
HAPILA specializes in developing efficient final step procedures for selective constitution of crystal structures and particle size distribution. HAPILA final finishing solutions can be applied to particle development according to requirements for dosage, release and stability, optimal polymorphic design, in particular for APIs and compounds for pulmonary applications, low and ultra-low dose formulations, difficult-to-micronize hydrates, esters, and low-melting substances.
The suite of technologies and processes available includes wetgrinding, micro-crystallisation, dispersion and spray drying.
Structure and history
HAPILA GmbH was founded in 2007 as an independent enterprise by scientists and technicians with long-standing experience in the pharmaceutical industry, with start-up investment of €3m.
Since then the company has experienced continuous growth and establishment of a successful business organization, international client base and regulatory compliance structure for cGMP-API manufacturing, European certification and grant of European and US patents on HAPIpur® technology.
HAPILA is run as an independent, stand-alone enterprise.
Quality and Regulatory
HAPILA ensures quality at every stage of process by combining direct management responsibility, individual employee empowerment and rigorous process approach, all supported by a comprehensive Quality Management system based on Standard Operating Procedures (SOPs) covering all processes that impact on quality.
By implementing a quality management system with its supporting structures, HAPILA has incorporated GMP (Guideline of Good Manufacturing Practice part II) and its legal stipulations (Ordinance on the Production of Pharmaceuticals and Active Substances AMWHV) into the fabric of its operations. As the demands on quality management increase with the progression of a project, these are verified by the quality functions to which qualified employees have been assigned.
HAPILA holds active ingredient-specific GMP certificates issued by relevant competent official authorities verified by regular official inspections.
The EDQM (European Directorate for the Quality of Medicines & Health Care) has granted HAPILA certificate of suitability No. R1-CEP 2013-277 under monographs of European Pharmacopoeia for production of micronized Estriol.