Biosynth GmbH is committed to innovative, high-quality custom conjugation tailored to your individual requirements.
Biosynth GmbH is a high technology service company in the field of drug delivery for biopharmaceuticals. We provide proof-of-concept, development and production services to leading, innovative pharmaceutical and biotechnological companies and research institutions all over the world. Due to the high quality demands in the development of pharmaceuticals, we have elaborated this Quality Statement with the intent to satisfy customer inquiries regarding our quality system and test certification. Biosynth GmbH understands the need for continuous improvement.
Our Quality Policy is to develop, produce, and deliver on time products and services that meet or exceed customers’ expectations. Biosynth GmbH is committed to combine innovation and flexibility with the need for high quality standards. To achieve this goal, we have implemented a quality control system with processes that are continuously improved to satisfy our customers’ changing needs.
For each of its branches, Biosynth has specified the tailored requirements for the quality management system. The international DIN EN ISO 9001:2015 norm applies to all branches of the company. This provides the flexibility needed for development projects and at the same time ensures high quality standards.
In its production facility and the quality control lab, which are are dedicated to the manufacturing of pharmaceutical excipients and APIs for use in clinical studies, Biosynth GmbH has implemented GMP according to the EU-GMP-guidelines. The quality control laboratory has been successfully inspected by the local authority (Landesamt für Gesundheit und Soziales – LaGeSo, Berlin). Thus, in December of 2019, celares received its GMP certification “for the release analytics of APIs.” (Download the PDF) Since 02/2021 celares GmbH also holds a manufacturing authorization “for conjugate vaccines” (Download the PDF).
We understand well the need for additional GMP inspections by the customers and can accommodate you in this regard.
Product and Service
Biosynth GmbH is committed to providing products and services with superior quality to our customers, and we have implemented a quality control system to assure this. We strongly emphasize Quality by Design and take preventive actions to build quality into our processes and products. By involving our customers in this process, we are able to prioritize their requirements and prevent deviations in our performance. All our services and products are provided according to specifications set out by celares in close cooperation with our customers and undergo testing to assure conformity. Additional test verifications are included to assure compliance with unique customer specifications when requested.
Continuous Improvement and Customer Satisfaction
Continuous improvement at Biosynth GmbH has become a way of life. Together with our customers, Biosynth GmbH’s highly motivated team constantly evaluates and improves the performance of company processes, as well as research and development capabilities.