Transforming Early Science into GMP Reality
PBio Consulting is led by Paul Wright, a senior CMC expert with 30 years of experience guiding biologics from early research through IND and into GMP manufacturing.
I partner with innovative biotechs to de-risk development and accelerate clinical readiness across mRNA, viral vectors, oncolytic viruses, recombinant proteins, and bioconjugates.
Through PBio Consulting, I provide strategic and hands-on CMC support across the development lifecycle — from interim leadership and process development to CDMO oversight and regulatory input. My approach is pragmatic, phase-appropriate, and built to keep your program moving.
Services Offered:
• Interim and Fractional CMC Leadership
Hands-on guidance across development, manufacturing, and CDMO partnerships.
• Process Development & Scale-Up
Integrated upstream and downstream support for proteins, mRNA, and viral platforms. DOE and QbD-based optimization.
• Tech Transfer & GMP Readiness
Robust DS/DP tech transfer packages, person-in-plant support, and readiness planning for GMP execution.
• CDMO Management
RFPs, due diligence, and proactive oversight to keep external partners aligned and accountable.
• Formulation & Analytical Development
Stability-focused formulation and phase-appropriate analytical strategies across modalities.
• Strategic CMC & Regulatory Guidance
Coherent DS/DP, analytical, and stability plans aligned to IND timelines. Authoring and review of Module 3 content.
• Laboratory Design
Practical design of labs tailored to real-world R&D workflows.
• Technical Due Diligence
Objective, rapid assessments of platforms and assets for investors and acquirers
Let’s connect:
📞 +1 (858) 215-2594
🔗 linkedin.com/in/wright-paul-andrew
Schedule a free 30-min intro call: calendly.com/paul-pbioconsulting/pbio-consulting-intro-call