HAPILA extends production capacity by installation of a pilot plant for BTZ043 anti-TB agent

Gera, Germany: – High-potency active ingredient specialist CDMO HAPILA GmbH (HAPILA) has extended its production capabilities by installation of another pilot plant. The new plant has already delivered first outputs of the innovative API BTZ043 used for tuberculosis (TB) treatment.

These initial batches from a five-step chemical synthesis extended by two further purifying crystallization steps will be used to support BTZ043 toxicological studies, commencing soon.

Fast build

Despite delivery and other problems due to COVID-19 restrictions, it took HAPILA only eight months from design to production start. The repurposed pilot plant now features three reactors up to 250 L with thermal equipment and devices for filtering, drying and exhaust treatment, allowing higher amounts of API to be processed within shorter timescales.

The new production facility secures stable support for clinical and toxicological studies carried out by the partners of the BTZ043 project, achieving higher annual quantity outputs and achieving very high specified quality standards.

The new capability should enable HAPILA to meet all anticipated demands for BTZ043 as well as demonstrating that it can produce the new substance to meet all specified parameters.

Anti-TB effectiveness

Tuberculosis is the most common cause of mortality worldwide caused by bacterial infections, accounting for some 1.4 million deaths annually.

BTZ043 is expected to meet global industry need for TB treatments that take effect more quickly and also overcome problems of growing antibiotic resistance among bacterial strains.

The new substance was first discovered by a team of scientists at the Jena-based Leibniz Institute for Natural Product Research and Infection Biology, also known as the Hans-Knöll-Institut (HKI), with studies confirming effectiveness against highly resistant strains of TB.

A Phase I study conducted in Germany, sponsored by Ludwig-Maximilians-University (LMU) Munich, showed good tolerability for BTZ-043, with current Phase IIa study investigating safety and effectiveness, in conjunction with upcoming toxicological studies. Studies are supported by the InfectControl 2020 consortium and the German Center for Infection Research (DZIF). Together, these form major milestones in the development of new drugs based on BTZ043 and will pave the way for the next Phase IIb clinical studies that will require significant quantities of the new API.

Dedicated development partner

HAPILA has been responsible for development of the chemical synthesis and the manufacture of the API BTZ043.

“Once again, we have demonstrated that HAPILA is a reliable partner for API development, with the expertise needed to develop practical solutions for sophisticated and highly active drug substances, with the ability to set up dedicated capability where necessary and meet the most rigorous regulatory standards,” commented HAPILA  CEO, Dr. Uwe Müller.

“It also shows we have the capabilities and commitment required to support a long-term drug development program, extending from synthesis development to providing all material and documentation required for APIs intended for clinical studies I through III, and also to scale the production to required market scale,” added 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 GMP 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 (CEP, ASMF, IMPD Drug Substance) to very high scientific and quality assurance (QA) levels.

It supports the development and manufacture of drug products with sophisticated 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, occupational safety and environmental protection guidelines. All HAPILA teamwork is focused on product quality and customer satisfaction.

All HAPILA chemical synthesis including chemical-physical tests for in-process controls and release testing are carried out in-house at its GMP certified plants and 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.

Learn more at: https://www.hapila.de/en/home.html

Resources

Click on Anti Tuberculosis Agent BTZ-043 commences Clinical Phase II for more information.