Merck

Viral Vector Contract Development and Manufacturing

Viral and gene therapy manufacturing

Manufacturing complexity continues to be a challenge within the gene therapy industry. Building internal capacity for viral vector manufacturing and supporting the facility with specialized experts can be prohibitively expensive and time-consuming. Consequently, most therapeutic developers choose to partner with contract development and manufacturing organizations (CDMOs) offering proven capabilities to take promising gene therapies from process development through to clinical and commercial manufacturing.

Reasons to outsource include:

  • Less overhead cost for personnel, facilities, equipment
  • Reduced time-to-clinic and faster commercialization
  • More scalable, reproducible, and robust processes
  • Fewer vendors and elimination of supply bottlenecks
  • Improved transparency and complete technical transfer
  • Expert regulatory support and risk mitigation


Trust and experience are critical in the selection of a contract manufacturer, which may be called upon to provide either discrete operations or end-to-end services spanning the entire viral and gene therapy lifecycle. The range of services provided by a world-class CDMO can encompass:

  • Cell and viral banking
  • Process development
  • Technical transfer
  • Clinical and commercial manufacturing
  • Sterile fill finish
  • Viral vector testing
  • Secure biostorage
  • Release to clinic
  • Administration to patients

CDMOs capable of handling these diverse responsibilities must possess extensive in-house experience producing a broad range of virus types and processes, as well as state-of-the-art facilities that are credentialed for current good manufacturing practice (cGMP) and process performance qualification (PPQ).

With safety and regulatory compliance critical to success, biologics manufacturing sites should be able to document completion of pre-licensure inspections by organizations such as the U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA). Such a one-stop resource gives gene therapy developers the means to integrate compliance, safety, and process development on a global scale if necessary, eliminating time and risk mitigation concerns. A notable example is the BioReliance® manufacturing facility in Carlsbad, California, the first CDMO in the viral vector manufacturing industry to complete pre-licensure inspections for both the FDA and EMA. This experience provides the basis for understanding and communicating critical factors in commercialization of efficacious gene therapy treatments.


Workflow

Gene Therapy Manufacturing

Gene Therapy Manufacturing

The rise of gene therapies is driving rapid innovation, but manufacturers face complex challenges bringing new therapies to life

Viral Vector Upstream Processing

Making the right upstream process decisions not only impacts viral vector titer, but downstream processes, timelines, and regulatory acceptance

Viral Vector Downstream Processing

Efficient virus purification processes can improve yield, decrease time to patient, and lower manufacturing costs

Viral Vector Formulation and Final Fill

Formulating a commercially viable gene therapy demands a high level of application and regulatory expertise

Viral Vector Characterization and Biosafety Testing

Critical biosafety testing and characterization of viral vector products can help to fully analyze key quality attributes: identity, potency, safety, and stability

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