Advanced Therapy Medicinal Products

EXPERT KNOWLEDGE

Your partner to make ATMPs more stable, robust and upscalable.

Towards more stable, robust and scalable ATMPs

IN LINE WITH LEGAL REQUIREMENTS FROM DAY ONE

In the coming years, ATMPs (Advanced Therapy Medicinal Products) like cell therapy will undoubtedly gain importance. However, production processes in this area are still labor-intensive, open, and hardly automatized. 

There is clearly a growing need to make them more stable, robust, and upscalable. In close cooperation with its innovative partner Antleron, QbD aims to answer this need by ensuring that advanced therapy processes are closed and automatized.

Our approach takes all compliance requirements into account, which companies need to respect when launching their products. 

With cell therapy, it’s even more crucial that all legal boxes are checked from the very beginning, as the R&D process will in time become the production process.

Personal solutions leading to specific processes

APPLYING OUR BROAD COMPLIANCE KNOWLEDGE

Furthermore, we will focus on the small scale of cell therapy, which breaks with the tradition of large-quantity manufacturing. Until now, small processes within R&D were usually translated to large-scale production through upscaling and tech transfer. With cell therapy, every solution is produced for one single patient – or a very small group of patients – so that it is not only small-scaled, but also truly personal.

As a result, some specific processes – such as logistics – will become vital in cell therapy. From the beginning, it will need to be clearly defined how cells will be obtained and how they will return to the patient, once their modification has been established.

Trabajos en ATMP - Trabajos en ciencias de la vida - QbD
Trabajos en ATMP - ciencias de la vida - QbD

In this regard, we need to take the characteristics of two types of therapies into account. In autologous cell therapy, stem cells are harvested from the patient. When the cell culture has been expanded ex vivo to large quantities, it is then returned to the patient. In allogeneic cell therapy, stem cells are harvested from a single donor. When these cells have been cultured, they provide treatments to large numbers of patients.

Backed by ample expertise and the drive to go the extra mile, QbD and Antleron join forces to develop the specific processes that advanced therapies require. To realize this, we will apply our broad compliance knowledge of GMP, GDP, GLP and ISO13485.

Overview of our solutions

QBD MODULE

QbD Module helps you resolve the abundant challenges currently faced in the development and production of a new ATMP.

¿Por qué asociarse con QbD?

YOUR DEDICATED ATMP EXPERTS
Le permitimos establecer un Sistema de Calidad acorde con las normativas FDA y EMA. Además, nuestra amplia gama de soluciones tecnológicas ha sido desarrollada específicamente para apoyar sus procesos de control de calidad.
Puede confiar en nuestros servicios de QP para la liberación de su producto. Disponemos de todas las herramientas para aprobar sus registros de lotes, incluso a distancia, si es necesario.
También tenemos el conocimiento y la experiencia para transformar sus pasos manuales en procesos automatizados y cerrados.
Tenemos la experiencia necesaria para validar y calificar sus equipos y procesos (automatizados).

Contacto

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Related whitepapers

EXPLORE OUR FREE ATMP WHITEPAPERS

Cell by Design: Why a practical framework is key to the R&D process of any cell-based ATMP

Analytical method validation: A validated process control method to determine cell density

A quality-focused process development roadmap
for ATMPs

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