HAPILA gains cGMP status for leading edge anti-tuberculosis API manufacture
Press Release | HAPILA GmbH
MAY 07, 2019
Gera, Germany: – High-potency active ingredient specialist CDMO HAPILA GmbH (HAPILA) has been granted Good Manufacturing Practice (GMP) certification for manufacturing of the anti-tuberculosis agent API BTZ043 for clinical studies.
GMP certification was granted by the relevant competent authority, TLV Thüringer Landesamt für Verbraucherschutz (Thuringian State Office for Consumer Protection).
HAPILA CEO, Dr. Uwe Müller, commented: “We are delighted to have passed this milestone, which emphasizes our status as a highly competent partner for API development as part of clients’ drug product development strategies.”
“From this specific example, they can see that we are able to do a complete synthesis development for an API and fulfill the requirements for manufacturing this active pharmaceutical ingredient according to the Part II GMP guidelines for API manufacturing, verification and release,” said Dr. Müller.
“This is particularly significant for pharma companies performing their own drug development as well as generic companies, SME’s and start-ups, developing new drugs who need specific API-experience on the field of small molecules,” he added.
This is the latest in a consistent record of GMP certificates for HAPILA, awarded after successful official inspections by local authority. They take place for every single API in strict rotation usually every three years. Inspection has focused on manufacturing activities, used plants and facilities, quality control, stability data program.
This latest certification mean HAPILA now has a total of five cGMP certificates for a range of APIs.
BTZ043 belongs to a new class of antibiotics, the benzothiazinones. As the representative of this family of substances, BTZ043 was the first to gain worldwide patent protection for its effect against the pathogen causing tuberculosis.
Following discovery of the structure of the active pharmaceutical ingredient at The Leibniz Institute for Natural Product Research and Infection Biology – Hans-Knöll-Institute (HKI) in Jena, a team of scientists and entrepreneurs has been involved in developing BTZ043 as a tuberculosis medication as part of a partnership involving Leibniz HKI, the clinical center of the Munich Ludwig-Maximillian’s-Universität (LMU) and the InfectControl 2020 consortium and DZIF research agency, initiated and supported by Germany’s Bundesministerium für Bildung und Forschung [Federal Ministry for Education and Research].
The GMP manufacture of the highly efficient active substance is performed at HAPILA’s advanced Gera facilities.
“We are very proud of contributing to the development of this tuberculosis drug which is so urgently needed and we will also accompany the further clinical studies with active substances from Gera,“ said Dr. Müller.
About HAPILA GmbH
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 is an independent company with particular experience in GMP-related development and GMP manufacturing, offering full regulated service for API (IMPD, ASMF) to very high scientific and quality assurance (QA) levels.
It 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.
All HAPILA chemical synthesis is carried out at in-house at its GMP certified laboratories at Gera, Thuringia, in east-central Germany.
When combined with purification and particle design, HAPILA’s chemical synthesis services cover the complete API value-creation chain, enabling it to be a highly efficient bridge-builder between API production and pharmaceutical end-use.