Manufacturing Sciences
and Tech Transfer
End-to-end biomanufacturing support
At Aptio Group, we help biopharma companies move from development to market with precision, speed, and confidence. Our experienced subject matter experts provide hands-on support across the full manufacturing lifecycle — from cell bank generation and process validation to commercial readiness and continued process verification.
We bring deep expertise in upstream and downstream process development, technology transfer, and campaign execution, ensuring your manufacturing operations run smoothly and efficiently. Our team supports both drug substance and drug product activities, including tech transfers, method transfer oversight, and in-use studies, to secure consistent product quality and regulatory compliance across sites and partners.
With extensive experience in regulatory strategy, CMO/CDMO oversight, and viral clearance planning, we help you manage complex interfaces and maintain compliance without slowing down progress. Our QC and analytical experts support method development, qualification, and transfer, ensuring analytical robustness from early development through commercialization.
From early-stage planning to plant-floor execution, we act as an integrated extension of your team — delivering reliable results, technical excellence, and confidence that your process is ready when it matters most.
Supported areas
Facility & Operations
- MSAT and equipment qualification
- Facility readiness and CMC project management
- Manufacturing operations and R&D support
- Overall operational excellence and compliance assurance
Typical consultant expertise
- Subject Matter Experts
- Project Manager
Process & Tech Transfer
- Bioprocess development (upstream, downstream, and drug product)
- CMC development and technology transfer
- QC method transfers and validation
- CMO partnerships, supply chain coordination, and process optimization
Typical consultant expertise
- CMC Program Manager
- Subject Matter Experts
Carsten Løvstrup Germansen
Vice President
Manufacturing Science & Tech Transfer
Carsten supports and leads commercial process readiness for biologics manufacturing processes in a wide array of areas, including supporting and leading process performance qualification and continued process verification activities. He has many years of experience that extend to critical domains such as CMO selection and assessment, as well as the assessment of master service agreements and supporting and leading process characterization and process improvement activities.