Welcome to Comberbach Consulting

Comberbach Consulting is a specialist consultancy with a wealth of experience in biopharmaceutical research & development, process scale-up & yield improvement, drug substance manufacture following current good manufacturing practice guidelines (cGMP), formulation, filling & finishing drug product. CCL also has experience in IND/IMP document preparation, setting specifications for product quality, managing client-subcontracted projects at Contract Development & Manufacturing Organisations (CDMOs), increasing process yields without jeopardising product quality, designing concept manufacturing facilities and calculating cost of goods.

Areas of Expertise

Comberbach Consulting Ltd offers a personalised, one-to-one service to biotechnology and pharmaceutical companies in process research, development, scale-up, cGMP manufacturing, process consistency and quality compliance — including interim management.

Also offered are design services for primary and secondary biological manufacturing facilities to FDA/EMA cGMP requirements.

CCL has specific expertise in biologicals (vaccines, monoclonal antibodies, cytokines & therapeutic proteins), combination products and cytotoxics.

Typical Work

  • Re-organisation/re-structure of pharma manufacturing organisations
  • Bio/pharma process/product development & project management
  • Interim management of R&D and manufacturing teams
  • Process troubleshooting, gap analysis and quality enhancement
  • Improving quality compliance pre-/post-regulatory inspections
  • Process yield improvement while maintaining product quality specifications
  • Design of drug substance and drug product manufacturing facilities
  • Concept studies & economic evaluations (CapEx/OpEx estimates)
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