Have you seen our latest case study? 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&GT) 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
  • 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




Time for Resolution 3 in the series with @katyspinkdhcg and Anna Rose Welch of Cell and Gene Collaborative/Life Science Connect! https://www.cellandgenecollaborative.com/doc/cgt-manufacturing-resolution-embrace-don-t-fear-deep-characterization-of-your-products-0001

.@katyspinkdhcg and Anna Rose Welch continue their New Year's discussion with Resolution 2:
Explore Novel Partnerships and Outsourcing Structures!
https://www.cellandgenecollaborative.com/doc/cgt-manufacturing-resolution-explore-novel-partnership-outsourcing-structures-0001

It's the fifth business day of 2022 and it's time for us to introduce our 4th and 5th hires of the new year. (We don't waste any time!)
First, let us introduce our newest Senior Consultant, https://bit.ly/DHCDoritHarati. Dorit brings experience in Quality Assurance, QMS, CMC, (1/3)

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