Pediatric Dosage Formulation

Case study
Drug product

A US-based global biopharmaceutical company known for its successful anti-infective products for adults was looking to reformulate the product into an age-appropriate dosage form for young children and pre-teen patients. The customer established a list of criteria for selecting a CDMO partner. Among its operational priorities, it identified:

  • Maintaining as closely as possible the train of equipment used to manufacture its adult and adolescent formulations.
  • Proven blending, compression, and coating capability, particularly of micro-tablets and oral granules.
  • Ability to handle a variety of batch capacities: engineering, design of experiment protocol, clinical batch, registration, and validation; scaling to commercial production runs.
  • International regulatory and significant commercial operational expertise.
  • Expertise in cleaning requirements for low-dose formulations.

In this case study, we learn how Cambrex’s demonstrated flexibility, responsiveness, and cooperation led to multiple pediatric formulation projects from our client, and more importantly, a strategic partnership.

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