HAPILA reaching completion of design for new GMP production plant for APIs

Gera, Germany: – High-potency active ingredient specialist CDMO HAPILA GmbH (HAPILA) is ramping up its production capacity with two new GMP plants now in its manufacturing pipeline.

HAPILA has almost completed concept design and identified a 240m² site for one new GMP production plant with capacities up to 600 liters and necessary filtration and drying capacities. It is also preparing technical specifications for another facility. Both plants are being designed to handle custom synthesis under GMP compliance to meet growing pharma industry demand for high quality APIs manufactured in the European Union.

Adding new APIs

The new plants will join HAPILA existing two cGMP manufacturing facilities, whose 100 and 250 L capacities are now struggling to keep pace with demand. The first new plant to come on line, Pilot Plant 3, will expand its capacities for existing products while the second, Pilot Plant 4, will provide platform for manufacturing of further products.

“Increasing our capacities will enable HAPILA to deliver higher amounts of APIs and a greater variety to provide new customers with our APIs for their approved drugs and for their drugs currently under development,” commented CEO Dr. Uwe Müller.

Fast track project

The concept design, developed in partnership with Weimar based Glatt Ingenieurtechnik GmbH (GIT) is almost complete, allowing work to start on engineering of interiors, transfer area and manufacturing facilities, to prepare detailed specifications for equipment and plant suppliers.

All installation steps will be accompanied by necessary regulatory qualifications, with installation planned to start at the end of 2021, to be completed within as short a timeframe as possible, bearing in mind that the COVID-19 emergency has caused bottlenecks on supplies and materials across Europe, longer delivery times for the equipment could be possible.

Large-scale synthesis

“These latest investments will further position HAPILA as a leading-edge partner for API development to support our customers’ drug product development strategies, starting with synthesis development, providing material including the required documentation for clinical studies 1 thru 3 and also being able to scale up GMP production to a suitable market supply that will be increased over the next few years,” said Dr. Müller.

“The new plants will allow us to process greater amounts of existing and future APIs, making HAPILA a suitable partner for larger scale synthesis, also for prospective new API projects,” he added.

Innovative API

HAPILA recently extended its production capabilities by enhancing one of its pilot plants to produce its innovative API BTZ043 used for tuberculosis (TB) treatment. The new production facility features three reactors up to 250 L with thermal equipment and devices for filtering, drying and exhaust treatment.

It is now securing 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.

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 HAPILA Sophisticated Drug Substances for more information.
More information about Glatt Ingenieurtechnik GmbH visit https://www.glatt.com/ppe.