Consultancy & Support
Expert guidance in Cell and Gene Therapy development.
At NecstGen, we are committed to accelerating the development and manufacturing of advanced Cell and Gene Therapies. Through our consultancy services, we offer expert, tailored support to academic researchers, early-stage innovators, and industry therapy developers — guiding projects from concept to clinic and beyond.
Navigating CGT Development Challenges
The journey from research to clinical application presents significant technical and strategic challenges. Scaling a CGT process from bench to bedside requires not only robust science but also strategic planning, and manufacturing expertise.
NecstGen’s consultancy services are designed to help you navigate this complexity. From early development to GMP manufacturing, we provide expert advice and actionable strategies that ensure your therapy remains on a clear, compliant, and efficient development pathway.
Why Choose NecstGen?
Scientific Expertise
Our subject matter experts bring deep knowledge in CGT development and manufacturing, grounded in real-world experience and the latest scientific standards.
Tailored Support
We customise our approach to your specific goals and challenges, ensuring practical and impactful outcomes.
Trusted Track Record
With a growing portfolio of successful collaborations, NecstGen is a reliable partner in advancing your therapeutic ambitions.
How We Support You
NecstGen’s consultancy offering enables informed decision-making across all development stages.
Our services include:
- Drug Development Plan (DDP) design and support
- Gap and strategy analysis
- Risk identification and mitigation planning
- Cost of Goods (COGs) evaluation
- GMP readiness and compliance guidance
Guiding your Therapy from Concept to Clinic
As your CDMO partner, we provide the strategic insight and operational expertise to accelerate development, manage risk, and ensure smooth progression toward market readiness.
Our CMC strategy connects process development, scale-up, GMP translation, and tech transfer.
We operationalise this through three workstreams: a focused DDP, cost-conscious COGs analysis, and GMP translation & compliance.
Drug Development Plan (DDP)
A Drug Development Plan acts as a strategic roadmap for your therapy: it supports regulatory alignment, defines critical milestones, and surfaces risks early. A well-defined DDP brings clarity to development stages and expectations, structures risk mitigation, improves scalability from lab to commercial production, and strengthens your positioning with investors.
Cost of Goods (COGs) Analysis
High COGs can limit the scalability and accessibility of CGTs. By identifying cost drivers and inefficiencies early, we enable cost-conscious process development, pricing strategies aligned with market access, and sustainable manufacturing models.
GMP Translation & Compliance
Transitioning from research to GMP manufacturing is a critical step. Ensuring compliance helps secure product quality and patient safety, enables consistent and reproducible production, and builds readiness for clinical and regulatory milestones.
Dr. Melissa van Pel — Head of Cell Therapy
Melissa offers 20+ years across cell and gene therapy development and manufacture. Since 2020 she leads NecstGen’s cell therapy product development and clinical production. Previously at Leiden University Medical Center (2003–2020) she headed the Cell Therapy Production Unit, optimised manufacturing processes, coordinated GMP projects (MSCs and blood‑derived products), authored regulatory documentation, and contributed to the iPSC GMP core team. PhD in Biomedicine (2003, Utrecht). Also experienced as Specialist Advisor in cell therapy and facility design.
Kinga Nowicka, MSc — Head of Viral Vectors
Kinga brings 10+ years in viral‑vector development and manufacturing. At NecstGen she leads process development and clinical production for CGT programs. Prior roles include leading process development at King’s College London’s Innovation Hubs for Gene Therapies (AAV & LV, automation and tech transfer) and senior leadership in vector PD at Autolus and Oxford Biomedica, where she also co‑authored CMC sections for regulatory filings (INDs, amendments, Type B/C, BLAs). MSc Drug Design & Biomedical Sciences (2012, Edinburgh).
Ready to Discuss your GMP Path?
Our experts are only a message away to help you identify suitable strategies and to allow informed decision-making.
We’d be happy to discuss and help you bring Cell and Gene Therapies to patients.
