High manufacturing capacity with consistent product quality
We have one of the world’s largest manufacturing capacities of bioprocess chromatography resins located in Uppsala, Sweden. The manufacturing site is certified according to ISO 9001:2015, and it consists of two physically separated multipurpose manufacturing facilities.
We have capacity to produce over 500 000 L of chromatography resins annually. We continuously expand our manufacturing capacity, and between 2017 and 2022, we are investing $70 million USD annually to significantly increase our production capacity at our chromatography resin manufacturing site in Uppsala, Sweden. Our scale of production allows us to adjust to meet increasing regular pre-pandemic customer needs. Additional investments are also ear-marked to address pandemic demand.
We are also investing $25 million USD from 2020 onwards in our cell culture business to increase our production capacity, and to expand our raw material characterization and digital manufacturing capabilities.
Long-term supply of chromatography resins is equally important as short-term supply. We are dedicated to supplying each BioProcess chromatography resin for as long as the products are knowingly used in approved, registered manufacturing processes for human therapeutics. This provision is formalized in a discontinuation policy signed by the CEO of Cytiva.
Our customized cell culture media products are not discontinued until there is a viable alternate material available approved by our customers.
To safeguard production for the future, a business continuity plan (BCP) is implemented at our manufacturing sites. The plan identifies and evaluates risks to critical assets, and mitigates the effects of unforeseen losses by having in place continuity and recovery strategies, developed at both corporate and business levels.
All our BioProcess manufacturing sites have been certified according to ISO 22301 Business Continuity Management (BCM).
In case of an incident that severely affects our manufacturing of chromatography resins, a strategic reserve of resins has been established to cover for deliveries during the business recovery phase. The reserve comprises resins used in approved and registered manufacturing processes of human therapeutics. This back-up inventory covers approximately 6 to 12 months’ supply, depending on the recovery plan for each product, until manufacturing is up and running according to our business continuity plan.
Currently the Reserve is located in two separate facilities, both facilities also being independent from our manufacturing sites. Resin types, volumes and storage locations of the Reserve are regularly reviewed to ensure effective deployment of materials globally should an incident occur.
We also regularly review our strategic warehouses for all BioProcess products and strategic reserves for chromatography resins. This is to ensure that there are the required risk mitigation plans and activities in place.
We require that all our suppliers have a quality management system in place corresponding to ISO 9001 or equivalent. Our critical suppliers are audited on a regular basis by trained and qualified supplier quality engineers. Other important requirements are: a supplier quality agreement, detailed information on financial status, compounds subjected to regulations such as REACH and components of animal origin, and a supplier business continuity plan.
Should a severe incident happen in our own supply chain, we can make use of our strategic reserve to cover for potential supply interruptions to registered manufacturing processes. In addition, we have identified at least one second supplier for most of our critical and important raw materials to reduce implementation time if required during an emergency.
We have an advanced understanding of the risks in our BioProcess supply chain using our in-house developed Sourcing risk finder tool: we have performed a detailed analysis of potential risks on over 10 000 parts in our portfolio covering more than 1000 suppliers.
- Policy for discontinuation of BioProcess and Cell and Gene Therapy products
- Policy for end of service support for BioProcess hardware
- Policy for discontinuation and post-discontinuation support of standard laboratory scale ÄKTA systems
- ISO certificate ISO 22301
- REACH statement
- Change control notification service
- Quality management
- Security of supply in genomics
- Strategic reserve statement
- Strategic reserve FAQ
- Regulatory Support
- Securing Today’s Biomanufacturing Supply Chain Using Transformative Supply
- Improving the Supply of Single-use Technologies
- Focus on Supply Chain Raw Material Variability
- Security of Supply in Cell and Gene Therapy Manufacturing
- How a robust Business Continuity Program helps to maintain operations in the face of a crisis