RDP Biopharma Consulting, LLC

Formulation & Drug Product Development Consulting for Biologics

About Me

Roberto DePaz, PhD, is a biopharmaceutical development leader with more than 20 years’ experience driving CMC strategy and process development across various biologic modalities. His specialized focus has been formulation and drug product development, and has encompassed monoclonal antibodies, fusion proteins, ADCs, enzymes, viral vectors, and subunit vaccines. 

Experience at top companies including Amgen, Horizon Therapeutics, Viela Bio, REGENXBIO, MedImmune (AstraZeneca), and AlphaVax.

Expertise

Formulation Development

  • QbD based, ensuring safety, efficacy, and stability
  • Suitability for route of administration
  • Excipient selection
  • Primary container selection (vials, PFS)
  • High-concentration formulation development
  • In-use compatibility studies

Drug Product Manufacturing

  • DP process development & characterization
  • Lyo cycle development
  • Tech transfer and person-in-plant support

Developability and manufacturability assessments

Pre-formulation studies

Forced Degradation studies

Biophysical characterization

Stability study strategy

CMC report authoring

Regulatory filings for CMC sections (IND, IMPD, BLA)

CMC Due Diligence for potential partnering

Vendor/CDMO management and oversight