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Service Centre

GMP Manufacturing - Cells and Cell based Products

Stemmatters, Biotecnologia e Medicina Regenerativa SA

Service Centre category(ies)

Cell Analysis / Flow Cytometry
Biobanks / Clinical Samples / Histology / Pathology
Cell Culture and Manipulation
Microbiology
Stem Cells
Genomics / Gene Expression Analysis / DNA Sequencing / DNA Synthesis / Real-Time PCR / Genotyping / Microarray

Description of the Service Centre

Stemmatters provides cGMP services regarding tissue processing, manufacturing and banking (cells and cell based products).The facility comprises 250 m2 of qualified controlled environment rooms (CERs) and material pass-boxes. Our quality management system ensures that our products are consistently produced and controlled according to strict quality standards (EU-GMP Guide/ICH Q7 and ISO 9001:2008).We work with specialized distribution networks to assure high quality according to GMP guidelines.

Service Centre web address

www.stemmatters.com

Contact person's name

Ana Margarida Frias

Contact person's e-mail

amfrias@stemmatters.com

Contact person's telephone

351253540100

Last edited on

2014-04-30 18:59:00

Services

Service

Quality Control

Available for external use?

Yes

Comments

Stemmatters performs a comprehensive range of analytical testing to ensure product quality and demonstrate the control of viable and non-viable particles, in all Stemmatters CERs associated with the aseptic preparation process. The quality control tests include: • LAL test for bacterial endotoxin quantification; • Mycoplasma detection by conventional PCR; • Microbial contaminants detection / Sterility tests (Bact/ALERT Microbial Detection System). The environmental monitoring program applies to: • Viable particle air monitoring, through active air sampling. Isolators have dedicated air samplers; • Surface monitoring using contact plates or surface swabbing of product contact areas and equipment; • Personnel monitoring of glove prints.

Service

Tissue Processing

Available for external use?

Yes

Comments

We provide tissue processing services for isolation of biological material from several sources, by adopting or developing standard operating procedures that are compliant with current regulations and cGMPs. Tissue procurement can be provided, as well as tissue collection and transportation systems which include all necessary documentation according to regulatory requirements concerning donor selection and eligibility.

Service

Cell Manufacturing

Available for external use?

Yes

Comments

Cell manufacturing services are provided under cGMP guidelines. GMP covers all stages of cell manufacturing/production. Our qualified staff has a broad knowledge and know-how in stem cells, with special emphasis to mesenchymal and hematopoietic stem cells from several tissue sources, such as adipose tissue, bone marrow and umbilical cord. We also manipulate other somatic cells, with emphasis to chondrocytes and endothelial cells. Services include: • SOP development and validation • Isolation, expansion, differentiation and characterization of human cells • Xeno-free and standard cell manufacturing SOPs • Xeno-free and standard cryopreservation SOPs Characterization service and assay capabilities • Flow cytometric analyses: in-process and product release cellular evaluation; • Cell viability and morphology evaluation through fluorescence imaging; • Immunolocalization of cell surface proteins and extracellular matrix; • Immunoquantification of cell metabolites; • Gene expression analysis; • Functional assays.

Service

Cell Banking

Available for external use?

Yes

Comments

Cell banking provides integrity of a cell population and assures that cells are readily available for subsequent application. The banking of stem cells and primary cells is maintained in a secure, controlled and monitored storage environment. Cell banking can be provided in different containers (vials or bags) storage tanks, in vapor phase of liquid nitrogen. Continuous temperature mapping is assured for all tanks.

Service

Cell Based Products

Available for external use?

Yes

Comments

We recognize the uniqueness of each project and work closely with our customers and partners to translate non-cGMP protocols into a fully scalable, reproducible, cGMP compliant process. Our strategy enables our scientific staff to identify and resolve technical issues with a method that is both time and cost effective. We can ensure that all of our cell based products, tissue engineering included, are provided according to validated standard operating procedures. Development and validation of standard operating procedures can be provided regarding manufacturing of cell based products. In the context of cell based product manufacturing, we can provide: • Support, advice and guidance in process validation; • Support and training in GMP manufacturing; • Development of product/process specifications.

Equipments

Equipment

Cell Manufacturing /Tissue Processing/ Cell Based Products Equipment

Service type: self-service or full-service?

Full-service

Comments

6 cGMP compliant cleanroom areas 3 Grade C/ISO 7 manufacturing rooms fitted with aseptic Isolators with positive pressure 1 Grade D/ISO 8 support room and cryostorage room Dedicated clean room and facility monitoring system Dedicated manufacturing room for cell expansion 3 Aseptic Isolators with positive pressure 6-Colour Flow cytometer 2 Liquid Nitrogen tanks for vials and bags Controlled rate freezer 4 CO2 incubators 4-D Nucleofector System for cell transfection Biosecurity Cabinet Class II

Equipment

Quality Control/GMP Environmental Monitoring Equipment

Service type: self-service or full-service?

Full-service

Comments

1 Bact/ALERT microbial detection system 1 Real-Time PCR Thermocycler 2 Forced convection ovens specific for Microbiologic samples 4 Airborne Particle Counters (6 channels) 3 Microbial Air Testers Cryopreservation room: 1 Device for continuous atmospheric monitoring (O2) with visual and sound alarms, and 2 sensors. The alarms activate the air extraction system for air renewal; 1 Portable O2 Detector.

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