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.
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.