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Single-Use Vs Stainless-Steel Bioreactors

April 17, 2020

 

 

This blog discusses the core differences between single-use (SU) versus stainless-steel (SS) bioreactors. Although there are now many SU bioreactors on the market, and these seem to be the preferred choice for most new installations, SS bioreactors are still being extensively used for many current manufacturing processes of licensed therapeutics. This blog aims to examine the two types of bioreactors, discussing the pros and cons for each type of bioreactor when used in the biopharmaceutical industry. 

 

Key differences in SU and SS bioreactors:

 

 

 

Description

Single-Use

Stainless-Steel

Vessel shape

Cylindrical and cubical shapes

Cylindrical shape

Clean-in-place/Steam-in-place (CIP/SIP)

Minimal

Required

Cost of goods (CoGs)

Reduced in maintenance, but high in consumables

High in maintenance

Plant footprint

Flexible infrastructure

Fixed infrastructure

Scales

20 L to 5,000 L

Up to 20,000 L

Operational friendly

Yes; fast turnover rate

Slow turnover rate

Quality validation

Extractables and leachables

Product and microbial contamination

Environment

Plastic waste

Water and chemical discharge waste

 

  • Vessel shape – SS bioreactors are cylindrical to accommodate high pressure steam sterilization and cleaning during CIP/SIP. The majority of SU bioreactors are cylindrical as they were adopted from the design of their SS counterpart. However, there are also some cubical shape SU bioreactors in the market which were designed to mitigate the vortexing effect at high agitation rate. 

 

  • CIP/SIP – CIP/SIP are part of the general operational process for SS bioreactors, and are required both at the start and the end of a biological run. CIP/SIP are not usually necessary when using SU bioreactors. 

 

  • Cost of goods (CoGs) – Routine CIP/SIP uses a large amount of caustic which results in increased utility costs with SS bioreactors. High maintenance requirements of SS bioreactors and the associated facilities also results in increasing CoGs. The high expense of SU bioreactors derives mainly from the ongoing consumables.

 

  • Plant footprint – The plant footprint in SS systems consists of fixed structures which lead to inflexibility and longer construction time. On the other hand, the SU facility can be constructed in a much shorter timeline and there is more flexibility to change the infrastructure for future development.

 

  • Scales – SS bioreactors can range from small-scale up to 20,000 L to facilitate large-scale manufacturing demand. SU bioreactors are limited by scales as the current largest size general system is 2,000 L. Larger scales up to 5,000 L are currently in the development.

 

  • Operational friendly – SS bioreactors require a longer turnaround time between batches as they require CIP/SIP in place. SU bioreactors have a faster turnaround time which can facilitate more production batches.

 

  • Quality validation – SU bioreactors would require a validation process to determine extractables and leachables. SS bioreactors do not have this issue, but if CIP/SIP is inadequate there could be issues with contamination. The impact can be substantial as it could result in downtime, long investigation process and finding alternative production sites.

 

  • Environment – Both systems produce waste. SU bioreactors result in accumulation of plastic waste, whereas SS bioreactors produce a large quantity of caustic-containing liquid waste.  

 

Perhaps there is no definitive case for which type of bioreactor is more superior. The decision-making process is usually based on the requirements such as products, market demand and timeline, and capital budget.

 

Currently, many start-up companies such as Contract Development and Manufacturing Organizations (CDMO) tend to go towards SU bioreactors as they have a faster construction time as well as high turnaround time between batches. This allows them to forecast more manufacturing batches. Most importantly, they can change between products without the concerns for product contamination. SU consumables may be costly, but this can be incorporated into the costing of the customer’s end. On the other hand, some biopharmaceuticals are adopting both SU and SS bioreactors as both types of bioreactors would give them the flexibility for change as well as capability for large-scale manufacturing.

 

You can learn more about bioreactors in the blog What Are the Different Types of Bioreactors?

 

 

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Andrew Low – Manager, Cell Culture Applications, APAC

Andrew brings many years of experience to Pall Biotech and is responsible for managing a team of bioreactor application scientists within the APAC region to support customers and commercial colleagues in upstream gene therapy, cell therapy and biologics applications.
Andrew brings many years of experience to Pall Biotech and is responsible for managing a team of bioreactor application scientists within the APAC region to support customers and commercial colleagues in upstream gene therapy, cell therapy and biologics applications.
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