It’s time for a new case study! You’re going to be hearing a lot about Pegasi, DHC’s brand-new proprietary data-modeling application. This flexible platform applies customized client inputs to quantitatively describe a range of probable outcomes for a wide variety of client-specific queries. This first Pegasi-specific case study specifically addresses COGs and facility modeling within the platform. Read “Pegasi: COGs and Facility Planning” now! 


cell & gene therapies

through unmatched expertise


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 one 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. In 2022, we brought out a new case study as part of our Facility Design & Engineering service area, known as Facility design: final design review. Thus far in 2023 we’ve published one new case study and it’s specific to Pegasi, our new modeling platform. Read it here.

See all case studies in one place here.

  • Comparability studies
  • Process codification
  • Process evaluation 
  • Process dev planning

  • Method development
  • Specification setting
  • Method transfer
  • Qualification & validation
  • Remediation
  • Comparability testing
  • URS development
  • Landscape scan & gap analysis
  • Custom device design
  • Contract manufacturing management
  • DHF & DMF development
  • Quantitative modeling
  • CMO selection
  • Technology transfer
  • Facility design
  • Failure analysis

  • QMS design and strategy
  • QMS gap assessment
  • Document authoring, review, and revision
  • Supplier oversight
  • Audits (see flyer below)
  • Capacity modeling
  • Process and facility design
  • Project management
  • Process and project engineering services
  • 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
  • Capacity planning
  • Cost-of-goods analysis
  • Build vs. Buy analytics

  • Needs assessment
  • Voice of customer surveys
  • Marketing strategy

  • Due diligence
  • Message optimization
  • Market positioning

Hot off the presses, a Reflection Paper on "General Considerations for Raw Materials Used in the Manuf of Human CGT Products," produced by the IPRP Cell Tx Working Group and Gene Tx Working Group. DHC's Tal Salz was involved in developing this guideline!

Look familiar? You must be in 🇪🇸 for @CHI_Healthtech's #BPSMTeu & saw Sanjin Zvonić chairing Adv Manuf Processes! Which means, at 11 am (3/16), you can catch DHC's @SaraDHCG presenting on the topic of Est Process Controls & Data in Prep For PPQ (Stream 4: Cell Therapy)! 🙌

🎼Happy birthday to us,
happy birthday to us, 🎶
🎵happy 9th birthday to Dark Horse...
happy birthday to us! 🎂🥳🎉

Just 24 hrs until @BioBreakOrg's Boston BioBreak begins! DHC's COO/MP @katyspinkdhcg, Senior Practice Expert Heath Coats, and Principal Brent Morse will be there and are looking forward to seeing you.😃

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