Comberbach Consulting’s Services

Comberbach Consulting is able to provide a range of services to help you fulfill your project requirements.

Interim management:

  • Day-to-day operational management of R&D scientists, process engineers and/or cGMP manufacturing workers
  • Temporary replacement of recently-departed senior executive(s) & integration of new hires
  • Building new scientific/engineering teams and/or re-structuring existing ones
  • Managing strategic capital investment (installing new manufacturing lines, buildings & infrastructure), consolidating existing capital assets and selling surplus equipment
  • Coaching young scientists/engineers for continuous professional development
Martin Comberbach of Comberbach Consulting Ltd

Project management:

  • Managing public-private partnerships (grant-funded projects)
  • Ensuring clients deliver projects on time and on-budget
  • Helping clients to choose a suitable CDMO and managing the relationship
Martin Comberbach of Comberbach Consulting Ltd

New Facility Design/Development:

  • Creating new immunotherapeutics process development & GMP manufacturing team
  • Designing new multi-product development & GMP clinical manufacturing facility
  • Managing construction, qualification, validation and approval from regulatory authorities
  • From green field to clinical trials of 3 different vaccines within 3 years
Comberbach Consulting Ltd as part of Les Isnes facility development

Documentation:

  • Business plans and presentations to potential investors
  • Site Master Files, Drug Master Files & Users Requirements Documents
  • Draft contracts (R&D, technical & process transfer, etc)
  • CMC part of IND(A) for clinical trials submission to regulatory authorities
  • Quality statements, SOPs and BMRs
  • Stability studies, QC specifications and QA release criteria
  • Organisation charts, headcount and operating cost estimates
  • Layouts, room & equipment lists, material/personnel flows and capital cost estimates
  • Concept studies leading to FES, Gantt charts, CapEx and OpEx estimates
  • Registration of manufacturing facilities with regulatory authorities (eg FDA)
Martin Comberbach of Comberbach Consulting Ltd

Technical support:

  • Reviewing product yields and suggesting a particular expression system
  • Fermentation process development including choosing equipment, culture components and suggesting improvements (eg by fed-batch) and alternative methods of product extraction/solubilisation
  • Purification process development including affinity chromatography, virus inactivation/removal steps and suggesting step-yield improvements (eg by resin change, extended washing, etc)
  • Selecting appropriate excipients for a drug formulation
  • Selecting appropriate product container, closure and seal
Martin Comberbach of Comberbach Consulting Ltd

Shop-Floor Quality Operations:

  • Observation of shop-floor manufacturing operations
  • Assessing compliance to ICH Q7 GMP guide & FDA 21 CFR Parts 210, 211 & 820
  • Performing sterility assurance gap analyses
  • Assisting Quality & Manufacturing teams pre-/post-regulatory inspections
  • Training, coaching & certification of new Quality Operations (QOp) personnel
  • Improving operator quality mind-set to reduce deviations & increase GMP compliance
  • Tracking and reporting Quality parameters (deviations, CAPAs, change controls, bioburden, contamination, etc)
Martin Comberbach of Comberbach Consulting Ltd

For more information on projects, please visit our portfolio page.

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