PharmaCell is a leading Contract Manufacturing Organization for Cellular Therapies and Regenerative Medicine in Europe.
Since foundation of PharmaCell B.V. in 2005, the company has become one of the leading Contract Manufacturing Organisations (CMO) focused on Cellular Therapies and Regenerative Medicine. As a Center of Excellence PharmaCell is helping to unlock the potential of Cellular Therapies for the benefit of patients. PharmaCell aims to be the leading CMO and Cell Therapy provider in Europe for human therapeutic cell therapy products to the global life science industry.
PharmaCell solely focuses on Cell Therapy Manufacturing and brings experience with autologous and allogeneic manufacturing for clinical programs for clients to bring SOLUTIONS in the design of the clinical program.
With a proven track record PharmaCell works with European and US-based biotechnology companies on pre-clinical to commercial development projects. PharmaCell covers the full range of manufacturing services. Starting from GMP consultancy, Process Development, fill and finish, QC-Testing, storage and distribution of clinical trial materials and Clinical Trial Manufacturing from Phase I to Phase III, we are also equipped to support and manufacture commercial cell therapy products for the European market.
In order to help to unlock the potential of Cell Therapies for the benefit of patients PharmaCell’s CMO services range from thorough transfer of technologies, QP release of products for the EU market, controlled temperature transportation to process development, including cell culture scale-up know-how and manufacturing of Advanced Therapeutic Medicinal Products.
PharmaCell aims to provide flexibility to clients, by
- Designing a Technology Transfer project to the requirements of the clients
- Structuring a manufacturing capacity program in line with patient recruitment
- Having project teams and cleanroom available around the clock (24 hrs)
PharmaCell is located in the center of Europe at approximately one hour driving distance from Brussel, Antwerp, Cologne and Dusseldorf. PharmaCell operates two state-of-the-art cGMP-licensed facilities for human cell & tissue culturing in Maastricht and Geleen (The Netherlands). PharmaCell’s two GMP Cell Manufacturing Facilities combine more than 4.500m² (55.000 sqft) offering the full range of flexibility and scalability. PharmaCell’s international team consists of experts related to all quality aspects, manufacturing, engineering, process development and project management. Each department has a representative in a dedicated core team that is committed to your product manufacturing and becomes involved from the Technology Transfer onwards.
Due to our broad expertise and longstanding know-how and our two cell manufacturing Center of Excellence PharmaCell is the CMO of choice for pharmaceutical and biotech companies, as well as academic institutions in this field.
Our Maastricht Cell Manufacturing Facility was first GMP certified in 2006 and has been successfully inspected by the Dutch Authorities (IGZ) on a regular basis thereafter. The Geleen Cell Manufacturing Facility was first GMP certified in 2012 by the Dutch authorities (IGZ) on a regular basis thereafter.
Each project has a dedicated project team with representatives from each department. This project team will be involved from the Technology Transfer to Clinical Manufacturing and ensure that additional operators will be trained with increased capacity demands.
PharmaCell aims to help accelerate technology development in the industry, mostly focused on upscaling and automation. PharmaCell is involved in projects with international consortia from both academia as well as industry to bridge preclinical development to clinical manufacturing.
At PharmaCell, we understand that every product is unique and requires a tailor made solution. We have designed custom solutions for packaging and shipment of multiple cell therapy product applications. We could help you design a custom made configuration.
PharmaCell provides scheduling options that ensure that the manufacturing capacity reservation is tailored to the patient recruitment within your clinical trial.
PharmaCell has experience with label design customized to your cell therapy product configuration. Within PharmaCell’s Quality System, a customized cell material collection receipt form as well as receipt confirmation of final product at the clinical site are standardized and available to be implemented in your clinical trial program.
PharmaCell systems utilize thermal control technologies, such as vacuum insulated panels and phase change materials to maintain product stability in any outside temperature variation. The configuration of refrigerants is calculated individually for each shipment based on product’s temperature requirements and is designed to maintain temperature within specified parameters for a long timespan to allow for any eventuality. Also, the controlled temperature shipments can be maintained at the clinical site in order to prevent temperature variations prior to administration of the product to the patient
All shipment configurations are qualified and can be validated according to the requirements within your logistical program, transportation route and carrying your product.
Your product can continuously be monitored via secured web server. PharmaCell has experience with specialized couriers and also has a dedicated transport by car: only your product is routed from and to the clinical trial location. This dedicated courier is trained to deliver your product to the clinical nurse and arrange the full paperwork.
Alexander Vos, Chief Executive Officer
Dr. Soenke Brunswieck, Director Business Development and Project Management
Number of employees: 70
Founded (year): 2005
Areas of Activity:
- Contract Manufacturing for Cellular Therapies and Regenerative Medicine
- Clinical Trial Manufacturing from Phase I to Phase III
- Commercial Manufacturing of Advanced Medicinal Products (ATMPs)
- Process Development, up-scaling and automation
- QC Testing
- Fill and finish
- Storage and distribution of clinical trial material
- GMP consultancy
- Founded in 2005 and GMP manufacturing license since 2006
- 2 state-of-the-art GMP Manufacturing Facilities of more than 4.500m2 (55.000sqft)
- International expert team covering the full range of GMP manufacturing and Process Development
- Approved expertise and track record for clinical trial manufacturing and commercial manufacturing for the European market
- Founding Member of Alliance for Advanced Therapies (AAT)
- Alliance Regenerative Medicine (ARM)
- International Society of Cellular Therapies (ISCT)
- Collaborations with American and European Life Science companies and academicals institutes in several FP7 projects and other activities
- Collaborations with Brightland Chemelot Campus B.V. – Euregional and international location for companies and educational and research organizations active in ‘advanced therapies’; in cooperation with Maastricht Health Campus