Your Partner for Process Development and cGMP Manufacturing

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Why Consider Goodwin Biotechnology?
Process Development and  cGMP Manufacturing Strategy
Characterization and Comparability Studies
Regulatory Strategy
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Process Development and cGMP Manufacturing Strategy

Goodwin Biotechnology will employ a risk-based, QbD approach from the beginning of your project through to the filing of your Investigational New Drug (IND) or Biologics License Application (BLA). 

In short, Goodwin Biotechnology will help to:
  • Identify your Target Product Profile (TPP)
  • Identify Critical Product Attributes (CPA)
  • Define and Refine your Product Design Space
  • Define your Process Design Space including Process Characterization
  • Define the Process Control Strategy
  • Execute Process Validation
  • Perform Process Monitoring
From cell lines developed from cDNA and Proof of Concept through the manufacture of clinical trial material, as your strategic partner, we focus on delivering the highest quality material as rapidly and cost-effectively as possible

Process Development
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For more information on our biosimilars services please fill out the form below.
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