Your toll Manufacturer by know-how, first-class Facilities and short lead times
Since 2001, Canvax™ has been an Original Manufacturer & Supplier of the Most Innovative Solutions, Services, Kits and R&D Reagents inside the Life Sciences field. Awarded as Most Innovative Company, with 10 Technologies Patented Worldwide or Unprecedented Milestones achieved, Canvax™ markets all its unmatched know-how, exclusive Expertise and worldwide leading R&D knowledge through its Reliable, Cost-effective and Easy-to-use Innovative Solutions.
As a reputable CMO, we are proud of our first-class facilities, located in Valladolid (Spain), specifically designed for the overproduction of biologics in microbial hosts, with a customizable and adaptable manufacturing structure.
Our 50+ employees, has decades of experience in development, scale-up, validation and transfer of bioprocesses. We will support you in every step of your project, offering you a unique understanding of the road map ahead up to product manufacturing.
CMO Manufacturing suites
We have a success track record with almost all the process configuration (USP & DSP), that could be reproduced at our state-of-the-art facilities in the quality grade of your choice:
Research Grade Manufacturing suite:
From small flask scale up to 500L Bioreactors, Canvax™ is able to supply your Recombinant Proteins with regular batches production.
The facilities combine the most common DSP operations units like:
- Clarification by centrifugation.
- Cell rupturing.
- Postproduction treatments.
- Chromatography techniques (affinity ie. IMAC, size exclusion, ion exchanges, amongst others).
- Much more.
cGMP Grade Manufacturing suite:
From regular production of ancillary reagents or enzymes used in the manufacturing of therapeutic products, to a regular contract manufacturing of research use only (RUO) material or cGMP-like ancillary or diagnostic reagents, Canvax™ has experience to be your toll manufacturer.
Canvax™ covers a customizable quality standard from ISO9001, ISO13485 to cGMP. Our cGMP manufacturing suite includes ISO Class 7 and 8 clean rooms and analytical and functional support laboratories to complete the quality product testing. Also, our facilities include a maximum fermentation capacity of 200L, mainly designed for microbial fermentation.
Canvax™ has proven track record supplying a broad catalogue of Recombinant Proteins (monoclonal, fusion, chimeric and fragment antibodies, biosimilars, enzymes, anticoagulants, vaccines, etc.) in a wide range of microbial expression systems such as Bacteria (E. coli, Bacillus, etc.), Yeast (Pichia, Saccharomyces) or Fungi (Trichoderma, Aspergillus and the revolutionary Dyadic’s C1 Expression System), etc.), Mammalian Expression systems such as CHO, HEK and insect cells like S2.
Our GMP Production Services enable you to transition from pilot to full-scale production batches quickly, without the disruptive fluctuations in quality that cost you time and effort; putting you ahead of the game and, thus, allowing you to go to market faster and with confidence.
Virtual and onsite site tours are available for audit.
Main differences between RUO and GMP
Some examples of products that we had manufacture during the last year, in gram-scale, meeting customer needs with short lead times are:
If you are interested in a different product, please Contact us.
Quality Management System
Canvax™ Manufacturing sites has been inspected by EMA, and is QMS build following Eudralex vol. 4 and 21CFR 210/211 principles.
Our robust Quality Management System (QMS), includes different processes such us Risk Management, Change Control, Purchases and Suppliers Management, Stock Management, Maintenance, Document Management, NonConformances Management and CAPAs, Clients Satisfaction and Complaints Management, Audits, Media and Solutions Preparation, Waste Management and Quality Management (Raw Material and Product Release Procedures).
In addition, Quality Agreements are stablished with Suppliers when deemed necessary due to the criticality in the process of the material supplied. There is a traceability of the raw materials and consumables from receiving until their use in manufacturing as per the guidelines described on the Stock Management SOP of the company. Comprehensive Batch, Master Production and Testing Records are generated for the manufacturing activities at Canvax™.
Also, Canvax™ has a Quality Assurance department independent to the production and QC departments which oversees the QMS system and approves the product release.
Due out stringent quality controls, Canvax™ can provide all the documenting requirements as: batches disposition package and required information (QA) like all production batch records including solution prep records, a batch disposition checklist, all QC Test/Request Forms (result worksheets) and associated QC testing raw data, Critical EM excursions, label issuance and reconciliation records, raw material specifications, any planned or unplanned deviations associated with the Customer’s product, related OOS result investigations, Certificate of Analysis, etc.
How to start?
If you are interested to learn more, please contact your closest Distributor, Contact us or fill out the form on the lateral. Our Business Development Team will contact you shortly.