Introduction to Continuous Bioprocessing
Continuous bioprocessing refers to the use of continuous manufacturing technologies for biopharmaceutical drug production as opposed to batch manufacturing which has traditionally been used. In continuous bioprocessing, bioreactors operate in a steady state where cells are maintained in an active growing environment and product is continually being harvested rather than operated in batches. Some key benefits of continuous bioprocessing include increased productivity, reduced manufacturing costs, improved process consistency and product quality.
Advantages of Continuous Bioprocessing over Batch Processing
There are several advantages that continuous bioprocessing offers over traditional batch manufacturing methods:
Improved Productivity: Continuous processes allow for uninterrupted production since multiple cycles can be run simultaneously. This improves overall equipment and facility utilization leading to a higher number of product units being produced in a given timeframe.
Lower Cost of Goods: The higher productivity of continuous processes directly translates to lower costs of goods sold on a per unit basis. Additionally, continuous processes require smaller facility footprints and reduced overheads since multiple production cycles can operate simultaneously.
Consistency and Quality: Continuous biomanufacturing ensures a steadier biological environment with consistent culture and operating conditions. This tightly controlled environment promotes consistent product quality and attributes from one batch to the next giving more reproducible results.
Flexibility: Continuous processes are highly flexible and scalable. Production capacity can easily be adjusted up or down by increasing or decreasing the number of simultaneous production cycles operating. This gives better capacity utilization and demand matching.
Real-time Process Monitoring and Control: Online sensors in continuous processes allow for 100% real-time process monitoring and tighter process controls. Any deviations can immediately be identified and corrected to ensure consistency.
Adoption of Continuous Bioprocessing
Several biopharmaceutical companies are actively adopting continuous bioprocessing technologies to manufacture their pipeline biologic drugs. Some notable examples include:
- Merck used a perfusion-fed continuous bioreactor from GE Healthcare to produce its blockbuster cancer drug Keytruda. This helped significantly improve productivity.
- Bristol-Myers Squibb is using idustrial-scale continuous centrifugation from Repligen to purify biologics with reported over 4-fold increase in facility capacity.
- Novartis partnered with Sartorius Stedim Biotech to design a scalable continuous biomanufacturing platform. They are evaluating its use for multiple pipeline molecules.
- Eli Lilly is collaborating with Genentech on development of a modular continuous vaccine manufacturing platform using perfusion bioreactors.
- Johnson & Johnson is implementing Thermo Fisher Scientific's WAVE bioreactor system for some of its clinical and commercial drug substance manufacturing.
While batch processes will continue being used for some mature products, most new bioprocessing facilities are being designed keeping continuous manufacturing in mind either for drug substance or downstream purification. This is also leading to the development of specialized equipment and platforms optimized for continuous use cases.
Growth Drivers for Continuous Bioprocessing
The key drivers which are expected to propel the growth of the continuous bioprocessing include:
CMO Adoption: Increased outsourcing of biologics production to contract manufacturing organizations is leading to faster adoption of modernized continuous technologies for improved efficiencies.
Capacity Constraints: Growing drug pipelines and capacity limits of batch facilities are compelling biopharmas to consider continuous processes for enhanced capacity and flexibility.
High Product Demands: Blockbuster biologics with multi-billion dollar revenues and stringent supply chain requirements are driving demands for industrial-scale continuous processes.
Regulatory Push: Regulators are encouraging more quality-by-design approaches which continuous bioprocessing better enables through real-time process understanding and control.
Operational Cost Savings: Tight cost management pressures are another factor prompting biopharmas to seriously evaluate continuous manufacturing for viable long term production strategies.
Startups Leveraging Continuity: Newer entrants are directly establishing flexible continuous production capabilities to gain competitive advantages.
The above interlinked macro factors are fueling investments into single-use bioreactors, modular facilities, and skid-based solutions optimized for continuous processing. This is expected to catapult the continuous bioprocessing to exponential growth levels over the next decade.
Continuous Bioprocessing - Segment Analysis
The global continuous bioprocessing has been segmented based on several categories:
Bioprocess Containers – The bioreactors & storage containers segment holds the largest share currently fueled by adoption of single-use bioreactors (SUBs). perfusion SUBs are seeing heightened interest.
Chromatography – Continuous chromatography solutions based on simulated moving bed (SMB) and annular chromatography are garnering attention from industry.
Consumables – Prepacked columns, tubing sets, sensors & probes tailored for continuous use see strong demand with overall growth.
Application – Commercial production holds the lead presently. Clinical & preclinical research applications are anticipated to gather momentum going forward.
Region – North American and European set the pace for now due to strong cluster of biopharma innovators and advanced CMOs in these regions. Asia Pacific predicted to scale up rapidly.
By solution type - The integrated continuous platforms including both upstream and downstream units in a modular format exhibit faster uptake compared to individual standalone equipment.
The US, Europe and Asia continue wrestling for the top position in the continuously evolving landscape with industry-academia collaborations and emerging economies being pivotal in its long term expansion.
Published Date: Nov 2024
