Are you familiar with the proposed draft guidance we submitted in mid-May for FDA consideration?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 If you’d like to contact us in regards to this draft guidance, please email  aavguidancedoc@darkhorseconsultinggroup.com.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&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



  • Capacity modeling
  • Process and facility design
  • Project management
  • Process and project engineering services
  • Due diligence
  • Message optimization




It's Q3 new-hire round-up time! Our newest Horses are Heath Coats, M.S. (Senior Practice Expert), Alexandria Ayala, J.D. (Assoc. Contracts Counsel), and Johann Sanseau, MSc. (who will be interning in our London office through early '23). Thank you for joining us, all!

We're looking forward to seeing you at @BiotechWkBoston's #CGTCONF this wk! On Thurs, be sure to watch for DHC CEO @ADaviesDHCG at the start of the day as he moderates the plenary panel on Rapid Expansion in the CGT Field - Mfg Capacity to Meet Demand. https://informaconnect.com/cell-therapy-bioprocessing/

Amazing news for these kids.💗 We've been avidly watching today for FDA's decision. Expect to see this mentioned in @katyspinkdhcg's updated consideration of what 2022 means for the field, forthcoming in our next Quarter Horse issue (available at month-end).

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