Biotechnologies - Import export

The step from the laboratory to manufacturing for clinical trials is a major challenge. Simple hand movements in the laboratory often cannot be easily translated into process steps of industrial manufacturing. We are specialised in such scale ups. Contact us for an initial discussion! Analysis We prepare your laboratory data and compare it with the possible process parameters at the contract manufacturer. If data or optimisations are still missing. We develop the test plan for this. We carry out certain scale-up trials (non GMP) at our technical centre. We accompany specific trials (e.g. with your API) on your premises or those of a plant manufacturer. Models and simulation From the data, we generate the process models you need for scaling up. You will also need these models for the submission documents. We use the data to simulate different scale-up concepts. So if you later transfer from the special CDMO for clinical production to the CDMO for commercial production

Freeze-drying is an important process for preserving and formulating pharmaceutical and biotechnological active ingredients. If an existing process is changed or transferred, the entire cycle must be modified. We advise on the adaptation of a freeze-drying cycle or scale up. Contact us for an initial discussion! Analysis We analyse existing data, model the process and verify the settings before the conversion. For them, this means: high transfer security, short project times, low overall costs. Adaptation of a freeze drying How do we go about it? For the time being, we analyse all existing data and "build" a model of freeze drying from it. The model is based on the physical principles and the real data of their current plant. Consequently, our predictions and forecasts are accurate. From the model, we obtain the settings for the new freeze-drying process. Before the step into production, these settings are verified with a small system.

We plan and perform your complete process validation. From the first gap analysis and risk management, planning, execution and reporting. We support you with full project management, providing support where needed. You free your ressources for your projects, we take care for validations and all connected activities. You reach your goals safely, quicker and faster.

Pharmaceutical and biotech apparatuses are calculated and manufactured according to your requirements. Stainless steel and special materials are used in the production. After that, the products are grinded, electropolished and tested using non-destructive testing methods, such as ferrite measurements, used for the determination of the ferrite content, or by using the riboflavin test to measure total discharge and CIP/SIP capability. All materials, methods and processes used have been documented in full in detailed QA documents and can be tracked at any time. You can depend on KASAG.

Pressure vessels, reactors, Pharmaceutical and biotech pressure vessles, Process containers, storage tanks, Modules, components, plants, High-pressure apparatuses,Heat exchangers, vaporisers, condensers, Cryo pressure vessels, technologies Nuclear technology, Vacuum chambers, vacuum apparatuses, Columns, according to PED (EN13445 / AD-2000), ASME (U-Stamp), China Stamp (A1), TP TC 032/2013 (EAC) Pharmaceutical and biotech apparatuses are calculated and manufactured according to your requirements. Stainless steel and special materials are used in the production. After that, the products are grinded, electropolished and tested using non-destructive testing methods, such as ferrite measurements, used for the determination of the ferrite content, or by using the riboflavin test to measure total discharge and CIP/SIP capability. All materials, methods and processes used have been documented in full in detailed QA documents and can be tracked at any time. You can depend on KASAG.