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Update your choices | BU : GMP BioManufacturing | Country : USA

Outsourcing clinical phase biologics development

Preparing for successful sponsor-CMO teamwork

Abstract

The long-term nature of outsourcing biologics process development and GMP manufacturing over the course of clinical trial development can involve unforeseeable events that could be a source of conflict between the sponsor and the CMO. In this article, we present the CMO’s perspective on various potential sources of sponsor–CMO conflicts, preventive actions to circumvent conflicts before they occur, and strategies for resolving conflicts as related to process transfer, development, and GMP manufacturing of biologics.

A successfully outsourced GMP manufacturing program is built upon a common goal and the management of numerous factors in the complex collaboration between the sponsor and contract manufacturing organization (CMO). The successful collaboration involves a synergistic exchange of each party’s knowledge and experience, combining detailed understanding of the product’s intrinsic properties, experience in process development and manufacturing, and GMP regulatory requirements for manufacturing, toxicology, and clinical trials.

In this article, the authors will present potential sources of sponsor–CMO conflicts, preventive actions to circumvent conflicts before they occur, and strategies for resolving conflicts as related to process transfer and development, and GMP manufacturing of bulk biologics.

Parts

  • Master service agreement
  • Project agreements
  • Quality agreement
  • Process transfer & Development
  • GMP Manufacturing of clinical batches
  • Conflict resolution in GMP manufacturing of clinical phase biologics

All White Papers and Technical Guides - GMP BioManufacturing



White Papers and Technical Guides - GMP BioManufacturing

Discover all our White Papers and Technical Guides related to biopharmaceutical drug development.


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