Archivel Farma offers a wide range of services to help biotech and pharma companies to develop and scale up their projects. Due to its dimensions and characteristics, the Archivel’s GMP plant is especially suitable to produce experimental or clinical batches of human or veterinary medicines.
Our specialized team can provide you agile, flexible and customized services. We will adapt to your specific needs whether you are looking for the manufacturing of sterile investigational medical products.
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GMP facilities
In order to develop and manufacture RUTI®, ArchivelFarma built its own plant in 2008. The 720 square meter premises are located in Badalona, only 10 km from Barcelona (Spain), in a well communicated area that also settles outstanding centers such as the Institute for Health Science Research Germans Trias i Pujol (IGTP) or the Josep Carreras Leukaemia Research Institute.
The plant is GMP certified by the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) for the manufacturing of human investigational medicinal products and Quality Control (QC) testing of clinical and human and veterinary commercial batches.
It is divided into two levels: The production area is located on the ground floor and is complemented by a small office area and a technical area. The analytical laboratory is located on the upper floor, as well as a large office space, with meeting rooms and storage area.
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Production area
The production area has three separated spaces:
- A 37 m2 Clean Room Class C with a class A unidirectional flow hood of 11 m2. It has autoclaves, sterilization and depyrogenation oven, weighingscales and drying oven.
- A 33 m2 Clean Room Class B with a class A unidirectional flow hood of 15 m2. It has shacker, weighing scales, freezer of -20ºC, lyophilizer (Lyobeta 20), homogenizer, dosing machine (Flexicon), encapsulation machine, and peristaltic pump.
- A 36 m2 Biosafety Level 3 (BSL-3) Class B Biocontainment Room for handling of biological agents classified as group 3 or lower. It includes a class A unidirectional flow hood of 9 m2 and 3 biological safety cabins (Type IIA). It has a freezer of -80ºC, double door autoclave, weighing scales, beat mill, incubator, pasteurization bath and centrifuge.
The production area also includes a reception area, a wash zone and a packaging area enabled to perform packaging and labelling of investigational medicinal products. The storage room includes spaces at room temperature, a refrigerator (cold room of 5 m2) and a -20ºC freezer. According to the GMP annex I the necessary equipment is available for microbiological and particle sampling and the cleaning, disinfection and nebulization of the clean rooms.
Analytical laboratory for R&D and Quality Control
The laboratory is structured in different working zones, a storage area, microbiological and phisico-chemical area, analytical area and sample room. It has a 100m2 capable surface with 24 linear meters of benches. It also has a storage area.
The available equipment is the following:
- Zetasizer Malvern
- Fluorimeter / Spectrophotometer
- Karl-Fischer coulometric
- Olympus microscope
- Particle visible reading equipment
- Gas hood
- Mobile gas hood
- Biological security cabin type II A
- Autoclave
- Isothermal equipment: 4 incubators, cellular incubator, -80ºC freezer, 5 -20ºC freezers and 3 refrigerators
- Precision scales
- pH meter
- Viscometer
- Conductometer
- Centrifuge 5810R
- Microcentrifuge
- Electrophoresis and transfer equipment
Contract manufacturing
The GMP plant has different areas, which allow working on a campaign basis, providing the following services for investigation medical products:
- Formulation and dosage of sterile finished products
- Design and development of lyophilization processes
- Secondary packaging and packaging of clinical batches
- Processes including manipulation of biological agents classified as group 3 or lower
- Storage of biological agents classified as group 3 or lower
- Development of biological processes in solid support (upstream and downstream)
- Quality Control and release of investigation medical products
- Individual parameter determination to be included in your batch Certificate of Analysis
- Batch Testing and Batch Release of clinical batches
For further information, feel free to contact us.
Analysis
We offer analytical services for the development of biological, physicochemical and microbiological methods for:
- Characterization of products
- Validation of methods according to ICHs, PhEur, USP criteria or client criteria
- Analysis of samples, in process control (IPCs), bulk and finished products
Biological analysis
- Identification and quantification of proteins, lipids, carbohydrates and DNA/RNA using techniques such as ELISA (enzyme-linked immunosorbent assay), TLC (thin-layer chromatography), SDS-PAGE and Western blot.
- Determination of biological activity, by applying ELIspot, ELISA, and/or Western blot to ‘in vitro’ power models and by using ‘in vivo’ power models in animal models.
Physicochemical analysis
- Determination of residual water content (Karl Fisher coulometric)
- Particle size and potential Z (DLS, Zetasizer Malvern Instruments)
- Uniformity of mass and uniformity of content
- Aspect and reconstruction parameters
- Determination of the pH
- Determination of visible particles
Microbiological analysis
- Microbiological control in non-sterile products
- Growth promotion test (GPT) for culture media
