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Click Here to View an “On-Demand Webinar” Evaluation of the “Scale-Out” Biomanufacturing Strategy from Early Clinical Stage to Commercialization 


Facility of the Future

Taking advantage of the advancements in disposable manufacturing technologies and in response to market demands for commercial manufacturing operations that reduce risk, costs and offer greater flexibility and scalability for product supply, WuXi Biologics designed and built a state-of-the-art manufacturing facility for commercial supply of biological therapeutics. See below the advantages of our manufacturing approach.

commercial mfg



  • Designed for multi-product production
  • Utilizes fed-batch or perfusion cell culture processes
  • Accommodates cell culture production platforms with a wide range of product titers (1-10g/L)
  • Able to manufacture mAbs, bi-specific abs, Fc-fusion proteins, ADCs and other recombinant proteins
  • Adapts to products with varying market demand from Orphan to Blockbuster biotherapeutics


  • Lower facility capital cost investment
  • Eliminate (or greatly reduce) expensive late stage scale-up process development and product characterization programs
  • Shorter and less intensive changeover processes between products or production campaigns
  • Reduced risk of losing lot due to one adverse bioreactor event
  • Low cost production enables penetration of biosimilars and biologics in emerging countries


  • Modular design with scale-out bioreactor strategy
  • Additional scale-out strategies by adding cycles via continuous process technologies
  • Production scheme adapts to product life cycle or market demand changes with minimal risk to product quality or process performance


  • GMP Compliance to US FDA, EMA and NMPA standards and guidelines
  • Traditional room classification and campaign operation
  • Processes/Systems are highly automated and include data historian and Manufacturing Execution System (MES)

Scale Out vs. Scale Up Commercial Manufacturing

The use of 14 x 2,000 L bioreactors for commercial production is a paradigm changing “scale-out” philosophy for commercial manufacturing. To understand the philosophy and benefits of the scale-out approach and for comparisons to the traditional “scale-up” manufacturing model continue to scroll down the page or view our on-demand webinar.


Click on the following links to see out extensive manufacturing capacities and future global facility expansion plans for both
Drug Substance  and  Drug Product 

What is Scale-out vs. Scale-up?

Scale-up manufacturing means using a larger bioreactor to produce the material needed for late stage clinical trials or market demand compared to the size of bioreactor used for early stage clinical production.

Scale-out manufacturing utilizes multiple bioreactors to produce late stage clinical material and market demand at the same size of bioreactor as used in early stage clinical trials.

Comparison of the advantages

Scale-up model

  • The current industry standard or status quo. It is well-known and expertise exists.
  • Many facilities and CMOs worldwide currently maintain scale-up capabilities.
  • This model is perceived as a cost effective means of production.

Scale-out model

  • Maintaining the same bioreactor size of cell culture manufacture between phases of development or market demand cycles means little risk to process and product quality as you scale-out.
  • Can develop design space and achieve high levels of process understanding very early in development making eventual validation effort faster and more efficient.
  • An adverse event in a single bioreactor does not mean the production lot is lost.
  • Utilize inherent advantages to single-use/disposable systems (risk reduction of contamination between runs in multi-product use facility).
  • Can make manufacturing scale decisions much closer to time when material is actually needed and more reflective of actual clinical and market demand.
  • Lower upfront costs (capital investment) to establish facility and facility can be operational and validated faster than traditional large scale bioreactor sites.
  • Using disposables for production means faster changeover between manufacturing runs and lowers risks of contamination events.
  • Can use single vendor or source for clinical and commercial production. Thus, less tech transfer costs, less time and money spent on vendor selection.

Scale-out manufacturing strategies offer greater flexibility, scalability, time and cost savings versus traditional scale-up strategies. Contact us to discuss further or to learn more!

Click on the following links to see out extensive manufacturing capacities and future global facility expansion plans for both
Drug Substance  and  Drug Product