Are you familiar with the proposed draft guidance we submitted in mid-May for FDA consideration? It’s titled Testing of Adeno-Associated Viral (AAV) Vector-Based Human Gene Therapy Products for Empty Capsids During Product Manufacture. You can read the press release here or jump directly to the complete document here. If you’d like to contact us in regards to this draft guidance, please email aavguidancedoc@darkhorseconsultinggroup.com.
accelerating
cell & gene therapies
through unmatched expertise
Services
We apply pharmaceutical industry best practices to the unique challenges of the Cell and Gene Therapy (C>) field. Our team can help you with a wide range of needs, spanning from high level corporate strategy development to detailed technical implementation.
We have a dozen commonly-requested services, listed below.
During 2020, we released 20 case studies to provide concrete examples of how our expertise can support your business. In 2021 we added two additional case studies to the bank. Both of them (Remediation of CRL issues for BLA resubmission, and Embedded early for de novo support) are applicable to six of our twelve service areas. See all case studies in one place here.
- Quantitative modeling
- CMO selection
- Technology transfer
- Facility design
- Failure analysis
- Comparability studies
- Process codification
- Process evaluation
- Process dev planning
- Method development
- Specification setting
- Method transfer
- Qualification & validation
- Remediation
- Comparability testing
- QMS design and strategy
- QMS gap assessment
- Document authoring, review, and revision
- Supplier oversight
- Audits (see flyer below)
- URS development
- Landscape scan & gap analysis
- Custom device design
- Contract manufacturing management
- DHF & DMF development
- Preclinical strategy
- Study design and oversight
- Vendor selection
- Technical writing
- Critical path identification
- Project management
- Strategic project planning
- Stage-gating
- Capacity modeling
- Process and facility design
- Project management
- Process and project engineering services
