Biotechnology SMEs require highly specialised skills to comply with evolving EU regulations, operate quality-controlled laboratories and production processes, and adopt advanced biomedical technologies. Standard training offers are often too generic and insufficiently aligned with companies’ actual workflows, equipment, development plans and regulatory obligations.

This skills gap affects areas such as GMP, MDR and IVDR compliance, genomic data analysis, advanced cell culture, laboratory accreditation, bioprocess scale-up, biosafety, analytical method validation, clinical trials and intellectual property. SMEs also face resource constraints when arranging in-depth training for larger groups of employees.

KOC Bio will create a company-driven training framework in which each participating SME identifies the professional courses and training providers that best match its processes and development needs. Training will be practical and biotechnology-specific, with each workshop comprising at least 12 pedagogical hours and potentially involving 10–100 employees per company.

Eligible training costs will be co-financed at 70% for small companies and 60% for medium-sized companies. The partnership model will enable SMEs to develop capabilities across regulatory compliance, quality systems, laboratory and production technologies, data analysis, biosafety, clinical practice and innovation protection.

The consortium will collect and assess the training needs of participating SMEs through a structured questionnaire, including planned topics, target employee groups and preferred training providers. Based on this input, it will define and coordinate tailored training programmes aligned with each company’s technical processes and field of work.

The partners will procure or engage suitable trainers and deliver workshops of at least 12 pedagogical hours in areas such as GMP, EU biomedical regulation, bioinformatics, cell culture, ISO 15189 and ISO 17025, bioprocess scale-up, biosafety, advanced analytical methods, GCP and biotechnology intellectual property. The project will also manage participation, eligible costs, documentation and reporting.

LABENA will act as applicant and project coordinator. Replika PRO will support preparation of the project documentation, coordination, implementation and reporting, subject to the stated contractual arrangements with training providers.