Our Services
Why NorthStar Bioprocess Consulting LLC
Our 25+ years of experience in the biopharmaceutical industry provides you access to the knowledge and strategies of advancing biopharmaceutical products successful through all stages of development.
Where NorthStar Bioprocess Consulting LLC Can Help
We do have extensive experience with a multitude of biopharmaceutical modalities through all CMC development stages
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Monoclonal antibodies, complex recombinant proteins, antibody-drug conjugates, and gene therapy
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Early- to late-stage biopharmaceutical process development
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Scale-up and transfer of biopharmaceutical processes
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Evaluation and implementation of new process technologies
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Selection and management of CDMOs
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Process characterization and validation (PPQ)
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Quality-by-Design approaches
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Viral safety (virus testing, viral clearance)
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Life-cycle management of approved products
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Support of Module 3 sections in regulatory filings
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Strategic CMC planning
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Project Management
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Due Diligence