Industry
Biotechnology Industry
GMP, GCP and quality system audit services for biotechnology organisations, biological medicine developers, biosimilar manufacturers, cell and gene therapy companies and clinical-stage biotechs building quality infrastructure.
The Regulatory Environment
Biotechnology organisations operate within a regulatory environment that is both highly demanding and rapidly evolving. The increasing complexity of biological medicines, monoclonal antibodies, ADCs, bispecifics, gene therapies, cell therapies, creates corresponding complexity in the regulatory requirements that govern their development, manufacture and quality control.
EU GMP Annex 2 (Manufacture of Biological Active Substances and Medicinal Products for Human Use), the ICH Q5 series on biotechnological products and the EMA ATMP Regulation establish detailed requirements specific to biological medicine manufacturing. These requirements layer on top of the standard GMP framework and demand sector-specific expertise to assess and audit effectively.
Sthira Assure supports biotechnology organisations from clinical-stage through commercial operations, whether building quality infrastructure for the first time, preparing for initial GMP inspection or managing the quality systems of commercial biologics manufacturing operations.
Key Frameworks
- EU GMP Annex 2
- ICH Q5A–Q5E
- EU ATMP Regulation
- FDA 21 CFR 601
- ICH Q10
- GCP ICH E6(R2)
Discuss Your Requirements
Get in TouchTypical Risk Areas
Biological Process Characterisation
Biologics manufacturing processes are inherently variable and require extensive characterisation to demonstrate consistent product quality. Regulatory inspectors assess whether process characterisation studies adequately define critical quality attributes, critical process parameters and their acceptable ranges, and whether in-process controls are sufficient to detect process drift before product quality is affected.
Cell and Gene Therapy Compliance
ATMPs present unique GMP challenges: small batch sizes, complex starting material chains of custody, stringent contamination control requirements and extensive release testing. The regulatory framework for ATMPs under EU Regulation 1394/2007 places demanding quality system requirements on developers and manufacturers at all stages of the product lifecycle.
Biosimilar Development Comparability
Organisations developing biosimilars must demonstrate comparability with the reference product throughout development, manufacturing process changes and scale-up. The regulatory requirements for comparability exercises are extensive, and inspectors assess whether comparability protocols, study designs and analytical methods adequately support the comparability conclusions drawn.
Adventitious Agent Control
Prevention of adventitious agent contamination is a primary concern in biological medicine manufacturing. EU GMP Annex 2 and ICH Q5A establish expectations for virus safety evaluation and viral clearance validation. Inspectors assess whether adventitious agent testing programmes, clearance validation studies and environmental monitoring programmes are appropriate to the manufacturing process and product risk.
Speak with a Biotechnology Audit Specialist
Contact our team to discuss your audit and quality system requirements.