HAPILA commences cGMP pilot scale manufacture of anti-TB API BTZ-043

Gera, Germany: – High-potency active ingredient specialist CDMO HAPILA GmbH (HAPILA) is commencing GMP compliant manufacture of its small molecule anti-tuberculosis active ingredient BTZ-043 in tablet form for clinical phase II B.

HAPILA has used highest quality intermediates to develop a micronized form of API based on several years development work. The improved synthesis route has been successfully transferred to pilot scale, which means HAPILA is now poised to perform synthesis to full GMP standards from its recently opened and fully certified pilot plants at Gera in Thuringia, east-central Germany.

Supplying clinical trials

The GMP production campaign for API BTZ-043, a potential active substance to treat tuberculosis, is expected to be finalized by early 2023, allowing HAPILA to support full clinical trials and meet all initial market needs for the API.

The newly developed synthesis process covers not only quality needs, but meets regulatory requirements regarding safety and environmental protection. HAPILA has already passed a GMP-audit related to BTZ-043 that confirmed compliance in all activities regarding BTZ-043 including development, synthesis, analytics and general documentation.

Regulatory support

HAPILA says it will be able to share its technical experience with its partners to support them towards their attempts towards toxicity-tests, clinical trials, and market supply for BTZ-043, including synthesis development, procedural challenges, purification methods and registration of with regulatory authorities such as EMA in Europe and FDA in North America.

Proven expertise

“Our rigorous quality control of every step of the synthesis route has resulted in a high purity API, with consequent benefits for clinical trials and end-product quality,” commented HAPILA CEO, Dr. Uwe Müller.

“The success of this manufacturing campaign has drawn on our years of experience in development of API-synthesis and once again confirms HAPILA as a reliable partner from small gram scale synthesis up to multi-kg API synthesis for supply of clinical studies up to market supply,” added Dr. Müller.

Combating highly resistant TB 

HAPILA’s development program has been conducted in partnership with the Leibniz-HKI Jena (Leibniz Institute for Natural Product Research and Infection Biology), which first discovered BTZ-043 at its Natural Product Research and Infection Biology laboratories.

The small molecule has been identified as effective against highly resistant strains of tuberculosis, which is the most common cause of death worldwide caused by bacterial infections.

Most of the research studies were also supported by the consortium InfectControl 2020 and the German Center for Infection Research (DZIF), as well as the Thüringer Aufbaubank for API development effort.

HAPILA undertook complete synthesis development for BTZ-043 as a tested and usable API as well as cGMP manufacturing, to comply with Good Manufacturing Practice guidelines covering Part II – API (Manufacturing, Verification and Release).

A Phase I study conducted in Germany showed good tolerability of BTZ-043. Proving BTZ-043 to be safe and effective in the current study Phase IIb, would be a major step towards the development of new drugs based on the substance.

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.

For more information, visit: https://www.hapila.de/en

Resources

Click on HAPILA BTZ-043 starts Phase II for more information.
Click on HAPILA extends BTZ-043 production capacity for further information.