Commercial Drug Substance cGMP Manufacture
WuXi Biologics maintains 460,000 sq. ft. of commercial drug substance and drug product cGMP manufacturing facilities in addition to our extensive existing CMC development and manufacturing capabilities. The commercial manufacturing campus is just down the street from our existing manufacturing site in Wuxi city.
The new facility accommodates 14 x 2,000 L disposable bioreactors for fed-batch production and 2 x 1,000 L disposable bioreactors for perfusion processes and is the world’s largest manufacturing facility to date utilizing disposable bioreactors (see press release). To learn more about our perfusion manufacturing capabilities including case studies see this webinar.
The site can produce a wide variety of biopharmaceuticals including monoclonal antibodies, bi-specific antibodies, Fc-fusion proteins and other recombinant proteins produced from mammalian cell culture. We utilize a “scale-out” approach to large-scale biologics production. To learn more about our “scale-out” approach, click here.
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.
- 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 CFDA 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 scroll down the page.
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.
Comparison of the advantages
- 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.
- 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.