Striving for continuous improvement
Keeping our focus on excellent performance to manage time to market and uncertainty.
Our state-of-the art facilities provide us with the necessary assets and capabilities for our operations to meet our customers’ needs while fulfilling the highest standards of quality, service and efficiency.
KEY PROCESS FOR NEW PRODUCTS
Speed, efficiency and reliability in the transfer of products
In order to ensure success, two sections are involved in this process:
Our Product Transfer Department has the main objective of ensuring that when a new product arrives at manufacturing, whether it is a new biomaterial or a final product, everything needed is ready and available: qualified equipment, manufacturing procedures, validation records and filling and packaging procedures.
Our Technical Support Department participates in the transfer of new products from R&D to manufacturing and assists the manufacturing department to guarantee the correct performance of the products.
Biobank, a key asset
> 190,000 samples
All our projects, from assay development, biotechnology and innovation can benefit from the samples collected and stored in our biobank that centralizes information associated with each sample.
Samples (serum/plasma) are used for product development and verification studies (sensitivity, specificity, sample stability, cross-reactivity and sample matrix studies, among others).
These samples have been sourced from worldwide multiple suppliers — universities, hospitals, reference laboratories, blood banks, other institutions and commercial suppliers — mainly in Europe and the USA.
Samples are mainly leftover but prospective collections are also done, and they are collected and managed under IRB/EC approval and in compliance with GCPs (Good Clinical Practices) and kept frozen at -80º in an access-controlled freezers room.
The implementation of sample management software provides our valuable biobank samples with security, traceability, data integrity, automatic import, location hierarchy and easy-to-use search.
All the Standard Operating Procedures in place are in according to Best Practices on biobanking.
