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Sempre più spesso vengono presentate ricerche che coniugano la medicina con la fisica quantistica. Il binomio può sembrare bizzarro, ma molti scienziati sono convinti che proprio in esso consisterà il futuro della scienza medica. Tra questi anche alcuni ricercatori dell’Università di Washington, che hanno sviluppato un metodo per controllare l’attività neurale, forse utilizzabile per ...
Gli adenovirus sono responsabili di una lunga serie di infezioni comuni, dal comune raffreddore ad altre malattie infiammatorie come congiuntiviti, polmoniti o cistiti. Si tratta di organismi che la medicina ha imparato a sconfiggere, ma che risultano comunque estremamente resistenti, per via della loro capacità di sopravvivere a lungo al di fuori di un ospite, anche se l’ambiente in cui vi...
Le donne, durante la menopausa, sono soggette a un irrigidimento delle arterie per il quale non è stata finora individuata alcuna strategia terapeutica. Un team di ricercatori americani ha ora scoperto un cofattore che sintetizza una specifica sostanza chimica in grado di migliorare notevolmente la funzione vascolare. Kerrie Moreau, docente di geriatria presso la School of Medicine dell`Universit...
PRODUCTION
Preclinical Manufacturing
Batches for pre-clinical studies and reference material can be prepared.
Adequate sample amounts can be supplied for validation purposes (e.g. viral inactivation/removal studies, sterile filtration). An accurate documentation of the preparation is made available for each sample to support its validity for its intended use.
cGMP Clinical Manufacturing
Activities are focused on producing monoclonal antibodies/recombinant proteins from cell culture and proteins purification according to appropriate regulatory standards in order to support clinical trials (phase I,II,III).
Tecnogen recognizes the importance of a fully integrated QA/QC function and has successfully established a quality-oriented approach to all aspects of the manufacturing process. We rely on disposable material in many steps of production
We can offer:
- Upstream processing/cell cultures
- Downstream processing/protein purification
- Fill and finish technology
Upstream Manufacturing
The Area is equipped with 25L, 100L, 500L working volume bioreactors that allow the cultivation of hybridoma and other mammalian cells to obtain biopharmaceuticals such as antibodies and recombinant proteins.
The bioreactors allow the cultivation of cells in perfusion /batch /fed-batch mode. They are equipped with automated devices controlled by a SCADA Supervisory System with two operator workstations able to start any operation in automatic mode. All the parameters, during cell growth, are continuously adjusted and recorded.
Master and Working Cell Banks can be prepared.
Downstream Manufacturing
The Area is equipped to support purification and formulation of proteins using a wide range of chromatographic techniques (e.g. Affinity, Ion Exchange, Hydrophobic Interaction), virus inactivation/removal and Tangential Flow Filtration.
The downstream area is designed with separated suites for virus+, virus- , buffer preparation, storage, and washing.
Our purification facility can support quantities from grams up to a kilogram per year.
Fill and Finish Manufacturing
The Area is equipped for aseptic filling, with automatic filling and crimping machines, both located in grade A environment with grade B background. There is an alarmed system for continuous particle and microbiological monitoring. Aseptic processes are validated by performing media fills.
A volume of bulk product as low as few hundreds millilitres can be handled. Filled vials are visually inspected; the vials are then labelled with an automatic labelling machine.
GDP/GCP Compliant Shipping
Shipping of clinical trial products is performed with dedicated transport at appropriate storage temperature and continuous monitoring. Short delivery times and great operational flexibility are achieved in cooperation with specialized and qualified suppliers.
