HAPILA extends role in ATHANA nanoparticle antifungal alliance to regulatory support

Gera, Germany: – High-potency active ingredient specialist CDMO HAPILA GmbH (HAPILA) has extended its role within the German federally funded ATHANA alliance to regulatory consulting and advanced synthesis for nanoparticle drug delivery.

HAPILA’s regulatory role will include identification and synthesis of possible degeneration products and their structure as well as documentation to support planned pre-clinical trials . These will include efficacy and tolerability studies as the Alliance closes in on a developed drug prototype for pre-clinical studies, projected for early 2025.

HAPILA is also tackling the complex synthesis challenge of functionalizing a polymer backbone with dyes for drug targeting.

Nanoparticle targeting for antifungal therapy

The ATHANA Antifungale Therapie Ansätze durch nanopartikuläre Zielsteuerung von Wirkstoffen (‘Antifugal therapy approaches through nanoparticulate targeting of active ingredients’) alliance comprises HAPILA and seven other organizations also based around Jena in the Eastern German Thuringia region.

Together, they are working to develop innovative formulations and applications based on highly targeted and region-specific nanoparticle delivery of an established API for the treatment of fungal pulmonary infections and diseases. This is expected to deliver better bioavailability and fewer side effects, compared with traditional oral solid dose delivery.

Project coordinator SmartDyeLivery GmbH is responsible for nanoparticle formulation, Leibniz HKI Jena is tasked with biological testing, Dyomics GmbH (functional dyes identification and targeting), Jena Bioscience GmbH (Dosage forms), BioControl Jena GmbH (Data analysis and process optimization), Dynamic42 GmbH (toxicity screenings) and Universitätsklinikum Jena as clinical partner.

The project has attracted significant funding from Germany’s BMBF Bundesinnenministerium für Bildung und Forschung (Federal Ministry of the Interior for Education and Research).

Synthesis and regulatory expertise

HAPILA CEO, Dr. Uwe Müller commented: “As this project has progressed, HAPILA has shown itself an increasingly useful partner with our ability to contribute cost-effective solutions that are also highly scalable to industrial manufacturing. This includes synthesis development as well as purification methods.”

“A particular challenge in this project has been the very specific forms of synthesis required for this highly innovative form of drug application based on nanoparticle technology,” Dr. Müller added.

“Now in these mid-stages of the project, our experience in the area of regulatory needs and ability to support development from concept to official approval of the active ingredient in the international market area is coming into play, along with our advanced facilities and ability to facilitate chemical synthesis from milligram lab scale up to several hundred kg,” he explained.

He noted that HAPILA had already proven its value in previous partnerships that also involved interdisciplinary coordination of various participants and expert groups, such as the development of the innovative anti-tuberculosis antibiotic candidate BTZ-043 with analogue tasks that started with a small-scale synthesis and are now supporting GMP-certified API for clinical trials Phase II.

About HAPILA GmbH

HAPILA GmbH is a contract developing and manufacturing organization (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 a fully 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 the 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 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: www.hapila.de/ecom

Resources

Click on HAPILA and ATHANA alliance receive funding for nanoparticle antifungal program for background information.