Have you seen our latest case study? It touches on six of our twelve service areas and follows the experience of a client who is new to C&GT (though otherwise practiced in late stage processes). That client required CRL remediation to prepare for BLA resubmission. Read more 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 (green buttons below) to provide you with concrete examples of how our expertise can support your business. The first 2021 case study, Remediation of CRL issues for BLA Resubmission, is applicable to six of our twelve service areas so we’re placing it up top, here, for clear and easy access.

  • 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
  • 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

Just over a week away! Are you going to @ASGCTherapy's 2021 Policy Summit?
Our COO, @katyspinkdhcg, will see you there...

FDA's #AAV #GeneTherapy AdComm prompted S2 of #PhacilitateTalks to interrupt scheduled programming, getting UCSF's AAV Gene Tx prof @Nicole_Paulk on the line with @GeorgiMakin and @ADaviesDHCG for an analysis of the future of AAV. Ep2, live now, here! https://bit.ly/3EetD92

Closing out this wk's #DHCQuantModel #DHCdeepdive, let's look at https://bit.ly/QMcasestudy1, in which the client saw a highly-customized, probability-weighted dynamic model of the likely range of capacity needs & mfg costs for its cell tx pipeline, based on Monte Carlo modeling.

It’s common to consider a detailed review as a way to capture problem areas. Sometimes, though, a review brings to light how little change is actually needed. The #DHCQuantModel in this case study provided unexpected great news! #DHCdeepdive #DHCpredicts
https://bit.ly/QMcasestudy2

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