It’s October of 2021 and we have a new case study for you! In this blinded real-life example, a pure-play gene therapy client whose product was just being spun out of academia brought DHC into the process to provide guidance over the long-term, conceptualizing and building a development process that would stand up to the challenges of each future trial phase and into commercial production. Check it out here.
Cell & Gene Therapy Specialists
Our team of experienced cell and gene therapy professionals bring deep domain expertise to assist our clients in achieving their strategic and operational objectives.
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’ve thus far released two additional case studies. 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, so we’re placing those links here for clear and easy access.
- 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
- Capacity planning
- Cost-of-goods analysis
- Build vs. Buy analytics
- 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
- Regulatory strategy
- Technical writing/editing
- Gap analyses
- Meeting assistance
- Preclinical strategy
- Study design and oversight
- Vendor selection
- Technical writing
- Critical path identification
- Project management
- Strategic project planning
- Stage-gating
- Needs assessment
- Voice of customer surveys
- Marketing strategy
- Strategic portfolio
assessment & analysis - Landscape analysis and competitive intelligence
- IP due diligence
- IP strategy
- Due diligence
- Message optimization
