Expertise

Three pillars clients can rely on: Modalities, Analytical Strategy & CMC, and Leadership & Management.

Modalities

Gene Therapy

Gene therapy — AAV platform
Viral vectors (AAV, LV)

Hands-on experience in the development of gene therapy platforms using viral vectors. Deep understanding of what drives vector quality, potency and reproducibility — from construct design to critical analytical control.

Built and operated an integrated analytical platform covering the full testing panel for AAV programs — including, for example, genomic integrity by ddPCR, full/empty capsid ratio by HPLC, and …

  • Process understanding of vector production and purification constraints
  • Definition and tracking of critical quality attributes (CQAs)
  • Assay design and qualification to ensure the complete testing panel
  • Integration of data for comparability and release consistency

Vaccines

Viral vectors (Adeno, MVA, …) Nucleic acids (mRNA, saRNA)

Operational experience across viral-vector and RNA vaccine programs, focusing on assay robustness, antigen expression, and safety evaluation throughout development.

  • Analytical definition of potency, identity, and impurity profiles
  • Control of residual DNA, host-cell proteins, and endotoxins
  • Stability and formulation testing for multi-dose and long-term storage
  • Risk-based comparability and traceability of key analytical data
Vaccines — viral vectors and RNA

Agritech & Environmental Biotech

Agritech & environmental biotech

Plant and microbial biotechnology focused on turning traits into reproducible outcomes — from genetic changes to measured performance in plants and microbe–plant systems.

  • Generation and screening of transgenic or edited lines
  • Assay design for phenotype validation (growth, stress, metabolites)
  • Development of beneficial microbial inoculants and application routines
  • Experimental designs for plant–microbe interaction studies

Analytical Strategy & CMC

Linking process and data to keep methods fit-for-purpose as programs scale.

  • Analytical lifecycle: screening → qualification → validation
  • Reference systems, controls and acceptance criteria
  • Stability, bridging logic and data quality by design
  • Fit-for-purpose documentation supporting clinical readiness
CMC & analytical illustration

Leadership & Management

Leadership & management

Hands-on coordination across disciplines to keep scope, timelines and data on track — and to build teams that can sustain delivery.

  • Team setup & structure: roles, operating model, ways of working
  • People growth: onboarding, mentoring, skill development and progression paths
  • Program governance: plans, milestones, risk registers & decision logs
  • Tech transfer follow-up and stakeholder alignment across sponsor/CDMO sites