Contract GMP Manufacturing
We offer contract GMP manufacturing services for aseptically prepared cell therapy medicinal products. All services are offered under quality management system to achieve regulatory compliance.
Contract GMP manufacturing services include but are not limited to:
Aseptic Processing (filling, packaging, labelling)
Qualified Person Release for clinical use
We also offer process development from preclinical to clinical grade manufacturing of cell therapy medicinal products and other biopharmaceuticals.
The transfer of R&D technology into GMP-compliant production can be complex and time-consuming. Cellin Technologies offers you an overview course on GMP-compliant manufacturing processes.
GMP Consultations and Training
Cellin Technologies has a highly qualified team who will give you an overview and insight into pharmaceutical biotechnology and GMP manufacturing of biological medicinal products.
Our courses are useful for personnel in biopharmaceutical companies, including staff from Quality Assurance and Control, Procurement, Business Development, Manufacturing, Project Management and R&D, Cleaning, Engineering and many more.
All training courses are custom-based and performed according to client needs. Prices will depend on the number of participants and the extent of the training.
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There is nothing worse than having to recall a product or face an adverse reaction due to microbiological contamination. Cellin Technologies has validated cleaning procedures and our cleanroom environment is being monitored according to EU guidelines.
We offer you a training course which provides all the necessary knowledge to validate a cleaning procedure. You will learn how to choose disinfectants and appliances and how to use the correct sanitation technique in different ISO classes. We will show how to compose a cleaning schedule and how to monitor its compliance.
In the manufacturing of sterile medicinal products the greatest source of contamination is the people. Correct gowning procedure is the very basis of aseptic work.
Cellin Technologies offers professional video courses on gowning and personal training together with visual and microbiological assessment. The course will have a theoretical and practical part. You will get step-by-step instructions together with acceptance criteria for validation