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Services
We reduce the “time-to-market” of new biomolecules thanks to our expertise to provide a holistic bioprocess solution. We do this by accompanying our equipment with a range of related services that help clients to take crucial decisions and support them all the way through the election, qualification, operation and maintenance of the most suitable technologies.
Bioprocess services
Bioprocess scale-up
Very often in the R&D stages, companies face the challenges posed by unconfirmed scientific hypotheses and gaps of knowledge. To enable bioprocesists to develop and study the viability of their bioprocesses at laboratory and pilot scales and ultimately scale them up to an industrial and regulated environment, Bionet offers the following:
- A proprietary microbial pilot plant with a range of bioreactors and other lab equipment that clients can use for proof-of-concept purposes during process optimization and validation tasks, and before purchasing decisions are made.
- The use of a range of bioreactor technologies (i.e. sensors, automation, etc) available at the pilot plant to assist in the definition of detailed user requirements and thereby supporting the election of the most suitable
- Tangential Flow Filtration (TFF) technologies and downstream processing specialists for the testing of clients’ broth samples with the purpose to evaluate the potential of this downstream solution for the particular process’ biomass and/or biomolecules. This ultimately facilitates the arduous task to screen out for the most suitable downstream technology to the process.
- A number of different TFF modes and components for the selection of the most appropriate TFF configuration.
QUALIFICATION
At BIONET, quality is part of our core culture and we apply it at all levels:
- We work under a certified quality management system, based on ISO 9001:2015
- We work under a QbD methodology which can include support for validation DQs, IQs, OQs for GMP.
- Software can be produced under GAMP-5 standards and compliant with CFR 21 C 11
TRAINING
Bionet delivers 1-3 days training at both, Bionet’s headquarters and/or at the client’s site.
The training can cover from the basics of the fermentation and tangential flow filtration theory to the very practical operational guides on how to use the technology to the highest standards
MAINTENANCE
The Support and Maintenance team at Bionet is ready to provide all year-round peace of mind via:
- A warranty of 12 months from installation and training date, of 13 months from unloading date or of 14 months from the communication about the availability of the equipment for delivery. The first out of these three options will be assumed by default.
- Prompt reactive services combined with regular scheduled maintenance visits.
- A practical design of all proprietary equipment.
- Assets availability, with a large post-sales stock of key equipment components.
