3P Biopharmaceuticals and Viscofan to collaborate in an innovate advanced therapy project
25 June, 2018 | General
Cardiomesh is the project in which 3P Biopharmaceuticals and Viscofan are collaborating to develop and manufacture an innovative cell therapy product. 3P Biopharmaceuticals has executed the tuning, the process validation and the GMP manufacturing for clinical use.
3P Biopharmaceuticals, a CDMO specialized in the process development and GMP manufacturing of biologics and cell therapy products, and Viscofan BioEngineering, the business unit within the Viscofan Group which is a leader provider of excellence products for collagen, are collaborating in the process development and validation as well as the GMP manufacturing of an innovative cell therapy product.
This product is an innovative cell therapy targeted to treat patients with heart failure by tissue regeneration.
This collaboration started in 2015 with the transfer of the process to 3P Biopharmaceuticals from Viscofan BioEngineering. 3P has an exclusive cell therapy area that managed the implementation and validation of the process, the scale-up and GMP manufacturing for clinical use.
High innovation in cardiac biomedicine
Cardiomesh is the name of this interesting collaboration that is developing and manufacturing an innovative biodrug property of Viscofan and named VB-C01. The therapy developed by Viscofan consists of a collagen membrane sown with allogenic stem cells that will be responsible for regenerating the infarcted tissue. It is therefore a combinated ATMPC (Advanced Therapy Medicinal Product) advanced therapy product.
The Project is moving successfully forward and two milestone have been already completed. The first one was in December 2017 when the he Spanish Agency of Medicines and Medical Devices audited 3P Biopharmaceuticals and certified the compliance of the GMPs need for biopharmaceutical manufacturing for clinical application. Recently, Viscofan has received the second good news thanks to the authorization of the AEMPS to undertake the clinical trial that aims to certify the safety and efficacy of the product.
Viscofan is a leader manufacturer of casings for meat products with commercial presence in over 100 countries around the world. Viscofan Group is the world leader in manufacturing and distribution of casings for the meat industry. The only one in the industry with the main technologies available: cellulose, collagen, fibrous and plastics. Technical innovation, product quality and customer service are our main drivers.
Viscofan BioEngineering is a business unit within the Viscofan Group located at its subsidiary, Naturin Viscofan GmbH in Weinheim, Germany, which is the Centre of excellence for collagen products in the Viscofan group.
About 3P Biopharmaceuticals
3P Biopharmaceuticals is a leading CDMO specialized in the process development and GMP manufacturing of biologics and cell therapy products. 3P offers its customers solutions at all stages of bio drug development: from initial research, preclinical and clinical phases to commercial phases. Its extensive experience in projects covering all stages of the process development and manufacturing in different expression systems (mammalian, bacterial and yeasts), its flexibility and adaptation as well as innovative technology and qualified team have made it an example for the international market.
3P has the support of an important group of investors: Cinfa Group. Cinfa Group is a holding of companies that handle different business lines in the world of health, with more than 50 years of experience and expertise in the biotech and pharma market. It’s flagship company, Laboratorios Cinfa, is a successful manufacturer that ranks first in terms of generic dispensed in Spanish retail pharmacies. http://www.3pbio.com/[:]