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Practical Guide to High Titer Monoclonal Antibody Production for Modern Bioprocess Development - Creative Biolabs

A Practical Guide to High-Titer Monoclonal Antibody Production

Achieving commercially viable monoclonal antibody titers is no longer optional—it is the difference between a promising candidate and a scalable product. This practical guide walks you through a real, end-to-end development journey, showing how an integrated platform takes an antibody from sequence to high-titer production and bioreactor scale-up with data at every step.

What’s Inside the Guide

  • End-to-End Platform Overview

See how a specialized antibody development and manufacturing platform links gene sequence optimization, vector construction, cell line engineering, upstream process development, and scalable production into one coherent workflow.

  • Case Study 1 – High-Yield, Stable Monoclonal Cell Line Development

Follow the complete path from vector design (PEAQ-BM124GS) and ExpiCHO-S host selection through GS-based selection, minipool screening, limiting dilution, and final clone banking. Learn how “champion” clones with titers up to ~0.9 g/L and >98% purity were identified and secured in a master cell bank for future GMP-ready runs.

  • Case Study 2 – Upstream Process Optimization to >1.6 g/L

Discover how systematic media and feeding strategy optimization turned high performers into ultra-high producers. The guide details basal media comparisons, Cell Boost–based fed-batch strategies, and data-driven decisions that pushed selected clones to titers up to 1.62 g/L while maintaining robust cell growth and viability.

  • Case Study 3 – Scalable Manufacturing in Single-Use Bioreactors

See how a shake-flask process was seamlessly transferred into a WAVE single-use bioreactor, with tightly controlled pH, matching growth and viability profiles, and consistent productivity. The study illustrates how early-phase performance can be reproduced at 5–10 L scale, including downstream Protein A purification and SEC-HPLC quality analytics.

Practical Lessons for COGS, Risk Mitigation, and Tech Transfer

The guide distills key takeaways on how high-titer processes reduce cost of goods, how to design selection and screening funnels that de-risk development, and what to monitor when moving from discovery-scale experiments into pilot and clinical manufacturing environments.

Who Should Download This Guide

  • Biotech and pharma teams planning to move antibody leads into development
  • CMC, process development, and manufacturing scientists evaluating external partners
  • Project leaders who need real data examples for clone selection, fed-batch design, and scale-up strategy
  • Emerging biotech seeking a proven roadmap from “good clone” to “manufacturing-ready process”

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