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
- Upstream and Downstream Manufacturing Support
- Technology Transfer Project Management
- Regulatory Support
- CMO/CDMO Oversight and Selection
- Viral Clearance Strategies
- Campaign Readiness and Support e.g. Person in Plant
- QC Analytics Support and HPLC method Development
Typical consultant expertise
- Subject Matter Experts
Process
- Upstream & Downstream PPQ Documentation
- Cell Bank Generation Strategy and Oversight
- Continued Process Verification
- Comparability Strategies
- Hold Time (Chemical and Microbial) Strategies
- Manufacturing Process Execution and Robustness
Typical consultant expertise
- CMC Project Managers
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.
