Mammalian (CHO) Clinical GMP Manufacturing and Support Activity Cost Analysis 2020-2022


The demand and need for therapeutic proteins, monoclonal antibodies, vaccines, and industrial enzymes has never been higher. This growing demand for biologics has led to an increasing number of Contract and Development Manufacturing Organizations (CDMOs) expanded their facilities. At the same time, the cost of selecting the right CDMO is high and increasing, both in terms of the actual cost of everything from technology transfer, to GMP manufacturing runs and stability studies but also in terms of making a strategic choice with a long-term partner.

 A typical CDMO bid for clinical GMP manufacturing and support activities cost millions of dollars, but the costs can vary widely, due to individual circumstances within a CDMO such as suite availability. This make it essential to know the possible costs and variability of the industry, so that an innovator (sponsor) knows they are getting a fair price for what services they are receiving. For the CDMOs, it is important to know how their company compares with others, to see if costs are in alignment overall and for each component of a clinical manufacturing program. This report will help both the CDMO and the customer understand the current pricing and dynamics so clear decisions can be made in a confident manner.

 This report provides the customer with a cost overview of the typical activities included in a full CHO clinical drug substance manufacturing program for phase1/2, with a comprehensive analysis of the following key activities: non-GMP Engineering run, GMP drug substance manufacturing run, Viral clearance studies, 36-months GMP stability studies, Technology Transfer, and the overall cost of a CHO Manufacturing Program. 21 data points from industry standard RFPs from various sponsors and CDMOs across North America, Europe, and Asia from 2020 to 2022 are analyzed and trends are discussed throughout report.


The present report analyses the cost in US dollars of a full drug substance manufacturing program using Chinese Hamster Ovary (CHO) host cells expressing various complex targets including proteins and monoclonal antibodies from actual sponsors and CDMO companies from 2020 to 2022, with a focus on clinical-stage manufacturing in support of phase 1-2 human clinical trials. 21 data points of actual RFP bids by CDMOs across three continents are the source of the costing data, expressed in averages, quartiles & range. See the Table of Contents below for more details.


The report includes an Executive Summary, tables and charts featuring average cost, quartiles, range and standard deviation in each activity as well as by geographic data.  The supporting text describes the most salient aspects of the difference among each activity and trends. Future trends are discussed based on a series of expert interviews with those active in preparing bids for sponsors and CDMOs. The report is available as a “pdf” file. The tables are available in Excel format.

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TABLE OF CONTENTS of the Current Report


1) Introduction

1.1) Data Source

2) Background on CHO GMP Manufacturing (page 8)

2.1) Overview of CHO Manufacturing

2.2) CHO host cell manufacturing

2.3) Process Flow of Mammalian Manufacturing Steps

2.4) Regulatory Requirements for GMP Manufacturing

3) Cost Benchmarking Analysis and Expected Future Trends of CHO Manufacturing (page 16-53) 

3.1) Non-GMP Manufacturing Activity Costs and Trends Background

     Average Costs 2020-2022

3.2) GMP Manufacturing Activity Costs and Trends

     Average Costs 2020-2022

3.3) Viral Clearance Study Costs and Trends

     Average cost 2020-2022

3.4) Stability Studies Costs and Trends

     Average cost 2020-2022

3.5) Cost per Bioreactor Liter of Culture & Trends

     Average cost 2020-2022

3.5.1) Raw Material Costs & Trends

3.6) CHO Manufacturing Technology Transfer Costs & Trends

     Average cost 2020-2022

3.6.1) GMP manufacturing Timeline Averages & Trends

3.7) Total CHO Clinical Manufacturing Costs & Trends (page 40)

     Average cost 2020-2022

3.8) Reasons why costs vary dramatically from one CDMO to the next (page 43)

3.9) Geographic Regional variations (page 45)

3.10) Discussion on CHO Manufacturing Trends for the next 3 Years (page 51)

Appendix – Data from all Cost Activities (page 54-68)