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! 

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 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

Advanced Therapies Could Be Sleepwalking into a Manufacturing Cost Crisis https://www.genengnews.com/topics/bioprocessing/advanced-therapies-could-be-sleepwalking-into-a-manufacturing-cost-crisis/

Thanks for everything, @Phacilitate and #ATW23! It's been a fantastic week. 🌴🧬🌞🐴 Wishing everyone an easy and safe journey back home. We'll leave you with this parting reminder: our consult page. Reach out anytime you think you might want some support: https://bit.ly/DHCconsult

OK, let's game-plan tomorrow. If you haven't already been to # 700, the DHC Lounge, you'll have until 12:30pm to stop by, get copies of any informational materials you'd like, and/or get a demo of #DHCPegasi, our proprietary data-modeling platform. Stay strong, friends!

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