Downstream bioprocessing involves the recovery and purification of biosynthetic products or biomolecules such as proteins, antibodies, vaccines, hormones etc. from fermentation broth or cell culture media. It typically consists of four main steps - cell harvest or clarification, concentration and washing, chromatographic purification and polishing and filling.The goal of downstream processing is to recover the target biomolecule in its native bioactive form with highest possible purity, yield and activity.
Adoption Of Single Use Technologies
Traditionally, downstream operations employed stainless steel equipment that needed to be cleaned-in-place between batches. However, the complex and time-consuming cleaning and validation of such equipment increased operational costs and delayed product release. To overcome these challenges, biopharma companies have been adopting single-use or disposable systems for downstream processing over the past decade. Single-use technologies utilize plastic pre-sterilized bags, tubing, connectors, filters and chromatography columns meant for one-time use. As they eliminate the need for cleaning and cleaning validation, single-use systems provide operational flexibility and rapid turnaround between batches. Their implementation has significantly improved productivity and quickened time-to-for biologics.
Advantages Of Single Use Systems
Some of the key advantages offered by single-use technologies for downstream bioprocessing include:
- Reduced facility footprint as fixed stainless steel equipment is replaced by single-use bags and modules. This lowers capital costs for new facilities or expansions.
- Elimination of downtime required for cleaning validations and changeovers between batches. Single-use systems allow for continuous processing.
- Minimal cross-contamination risk as each single-use system is discarded after one production campaign.
- Improved product quality due to reduced operator handling and material contacts within sealed single-use circuits.
- Easy scale-up from clinical to commercial manufacturing as processes can be replicated using same single-use equipment of larger capacities.
- Higher flexibility to accommodate process changes quickly without equipment modifications or re-qualification.
Widespread Adaption Across
Leading this shift towards Single Use Downstream Bioprocessing are large biopharma companies involved in commercial production of blockbuster antibody drugs and vaccines. For example, manufacturers of top selling monoclonal antibody therapies such as Rituxan and Herceptin have completely switched to single-use systems for Purification and Viral Clearance from their original steel-based facilities.
Similarly, vaccine makers like Sanofi Pasteur, Merck and GSK have implemented single-use technologies across concentration, chromatography and viral filtration steps in response to public health emergencies. Their ability to rapidly deploy additional single-use capacity was critical during COVID-19 vaccine production ramp-up.
Even smaller biotechs and Contract Development and Manufacturing Organizations have embraced single-use systems owing to advantages in terms of CAPEX and flexibility for clinical stage manufacturing. According to surveys, over 80% of new and expanded bioproduction facilities now rely primarily on single-use equipment for downstream processing.
Continued Evolution Of Single Use Portfolio
Driven by growing demand, vendors have continuously enhanced the functionality, robustness and scalability of single-use technologies. The portfolio today includes larger volume single-use bioreactors capable of 2000L production along with single-use skids for integrated downstream tasks like capture, polishing chromatography and viral removal.
Advanced single-use sensors have also been developed for in-line process monitoring of
critical quality attributes. Meanwhile, novel single-use mixing technologies help overcome mass transfer limitations faced at larger process scales. As single-use solutions match and exceed the performance of stainless steel assets, their acceptance in bioprocessing is poised to rise further in the foreseeable future.
Cost Savings With Single Use Implementation
While single-use systems incur higher material costs, numerous studies have demonstrated their ability to reduce overall production expenses significantly. A case study comparing equivalent 200L fed-batch monoclonal antibody processes estimated 30-50% lower capital costs and 20-30% reduction in overall manufacturing costs with a fully single-use flowpath. The freed-up capital is re-invested to boost overall biomanufacturing capacity.
Furthermore, single-use technologies allow continuous processing gains like higher annual facility utilization upwards of 80-90%. Their implementation has progressively slashed cost of goods per gram for blockbuster biologics, helping the deliver more affordable treatments. As bioprocessing moves towards integrated single-use solutions driving lower costs and quicker deliverables, they will facilitate access to life-saving therapies worldwide.
Single Use Downstream Bioprocessing have revolutionized downstream bioprocessing and emerged as the prevalent manufacturing platform across industrial and academic settings. Their adoption is transforming the traditional stainless-steel based biomanufacturing infrastructure to a more capital efficient and flexible single-use based paradigm. Going forward, further tech enhancements will see single-use solutions matching multi-product facilities while achieving order-of-magnitude reductions in commercial biologics production costs.
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Author Bio:
Money Singh is a seasoned content writer with over four years of experience in the market research sector. Her expertise spans various industries, including food and beverages, biotechnology, chemical and materials, defense and aerospace, consumer goods, etc. (https://www.linkedin.com/in/money-singh-590844163 )
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
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