Katarina Andersson

Led a high-performing team within the Cell Therapy department, driving projects to completion within set timelines and budgets. The team focused on providing high quality starting materials (e.g. hPSCs and regulatory T cells) for pioneering research and bridging the gap between early research protocols and pre-clinical stages. Emphasis was placed on developing and providing robust and standardized protocols and using clinical approved materials and reagents. The role involved extensive collaboration with interdisciplinary teams across research, pre-clinical and regulatory sectors, to streamline the transition of research discoveries to pre-clinical development.

Led the manufacturing team focusing on the development of clinical-grade hESC lines. Developed and implemented novel xeno-free GMP compliant derivation protocol based on scientific data. Played a key role in the planning and establishment of a GMP facility aimed at producing starting material for ATMPs. Successfully set up a comprehensive GMP quality system, authoring and implementing critical production procedures (including Standard Operating Procedures and Batch Records), ensuring the highest standards of quality and compliance. Held a leadership role during audits with the Swedish Medical Product Agency.

Planning and coordinating shipments of biological material to customers.

In collaboration with Novo Nordisk played a major role in the innovation and development of a differentiation protocol to generate beta cells from hPSCs, to advance the field of diabetes research and regenerative therapy.

Specialised in the derivation, culture and quality control of hPSC, developing innovative culture systems. Involved in advancements in differentiation of hPSC into hepatocytes and cardiomyocytes and the translation of the protocols into a manufacturing setting.

Pioneered the establishment of a laboratory for research on hESCs, leading to the derivation of the first Latin American hESC line. Worked as an embryologist at the IVF clinic, enhancing the clinic's capabilities in reproductive technologies.

Leading the production team working with derivation, culture and quality control of hPSC. Derived and banked more then 30 new hESC lines. Tech transferred and standardized new culture systems for culture of hPSC, and differentiation of hPSC into hepatocytes and cardiomyocytes.