Production at CANDOR

Each of the solutions and buffers of CANDOR have one major component: Water! It is obvious that we have to focus on the highest purity of our water for production. Not to mention that we cannot accept changes in water quality during production of our solutions. Thus we checked many different kinds of water purification systems and different suppliers. Our choice is to work with a water purification system produced by TKA (Part of Thermo Fisher Scientific). This system has been set up and is under the constant control of our own technicians as well as periodical maintenance by TKA service technicians. This gives us the safety to have high quality water for production at any time. The first stage of expansion of our system, which has been set up, has a daily production capacity of 2,500 litres. Additional identical modules can be implemented to replicate this capacity without changing the process of purification and thus without changing the water quality. Important parameters of water quality like conductivity or TOC are continuously monitored. Control limits are implemented and automatically checked. Control measurements are documented regularly.

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CANDOR produces buffer solutions in industrial sizes. Thus we have to mix salts, buffer components, proteins, organic and inorganic raw materials and other biomolecules in all batch sizes. Standard batches at our facility range from 1 litre to 1000 litres. Higher volumes are available on request. It is obvious that we need a very good mixing system, which not only works reliably with consistent and adjustable forces, but with high speed and very effectively. We need a system, which has nearly the same characteristics starting from 1 litre pilot-batches up to 300 litres or 1000 litres production batches. Up-scaling is a major task for industrial production of modern solutions. We cannot accept changes in mixing efficiencies, speed or characteristics during scale-up processes. Thus we are equipped with the complete family of magnetic stirrer products from 2mag AG. We can use the same mixing technology for any volume and can adjust mixing forces and speed product-specifically. Production paramaters for mixing can be fixed in our SOP’s and at any of our different production stations, so that we can run the same mixing program for the same product. This adds reliability and robustness to our production processes. Furthermore the 2mag drives are made for permanent operation and thus we can run them day-in-day-out for any period needed. The surfaces of our magnetic stirrer have tight stainless steel housing. Cleaning procedures can be done easily for maximum hygienic standards in all our production runs.

Important aspects for process parameter control devices are:
Highly reproducible measurements in any kind of solution (ranging from high purity water up to highly concentrated protein solutions).

1. Maximum independence of the results from process parameters like temperature changes in the solution.
2. Easy documentation with data-integrity.
3. Appropriate user interface for easy and fast measurements.

We decided to use very robust production control devices at each production station in addition to a central batch-release testing system (ProLab 4000) which meets FDA standards for documentation and data-integrity. Iodine/Iodide reference system electrodes are used for pH-measurements. This enables fast response times, very good robustness of the electrodes as well as useability of the same electrode type for protein-free and proteinaceous solutions. Furthermore this modern reference system is less sensitive to temperature changes than other ones, e.g. as Ag/AgCl.

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Weighing processes are part of every production process at CANDOR. Thus we have to rely completely on the accuracy of our weighing. Starting from the analytical balances and precision balances up to industrial weighing platforms with adequate terminals we chose the high-end products from Mettler-Toledo. All such instruments meet FDA requirements for analytical precision, reproducibility and documentation procedures. Furthermore they are easy-to-operate, the terminals are easy-to-read and they are optimized for easy cleaning. The industrial platforms and terminals are completely covered with stainless steel for easy-cleaning and highest hygienic standards. All scales are monitored by our own technicians and additionally we run service contracts with Mettler-Toledo for all these instruments. Thus every scale is maintained and inspected routinely. Furthermore the calibration service of Mettler-Toledo ensures correctness and traceability of results at any time.