Proteins manufactured within our ISO 9001:2015-certified facility
with stringent in-process control measures
- Robust in-process controls and stage-gate analytics are employed to maximize lot reproducibility:
- Comprehensive protein expression parameter analysis conducted prior to refolding (if necessary) or purification
- Gel electrophoresis analysis used to validate proper refolding
- Chromatogram and analytical gel electrophoresis performed after each step of protein purification chromatography, compared against documented standards
- Thorough oversight of the entire process and manufacturing procedure is maintained through the Qkine bespoke ISO 9001:2015 quality management system
- Experimentally determined shelf-life and shipping stability analysis ensure the protein maintains its reproducible bioactivity during global transit to our customers
- Detailed, lot-specific certificates of origin (CoO) and certificates of analysis (CoA) are provided
- The custom design of our UK manufacturing facility includes provisions for beta-lactam-free production. No baculovirus is handled on-site
Qkine was founded in 2016 and operates from the Cambridge Science Park, UK. The Qkine quality management system has been implemented to comply with the requirements of ISO 9001: 2015. The quality management system is applicable to the development and manufacture of products; sourcing of raw materials and products; commercial and operational activities.
Quality policy statement
At Qkine, we are committed to providing the scientific community, our customers, with the highest purity innovative recombinant protein reagents and related products to support scientific discovery and champion reproducibility in science. We are also committed to working with emerging sectors, such as cultured meat and animal-replacement technology providers to create a more sustainable future built on strong science.
Our guiding principles are
The fundamental biochemical quality of our products and open, honest and proactive customer service is core to what we do. We will undertake stringent purity and bioactivity testing data for all proteins and this will be communicated effectively to our customers. We will provide the highest level of transparency whilst protecting our intellectual property.
Our team are dedicated to solving stem cell culture challenges for our customers and seek out the best solutions for the supply chain needs of the stem cell and regenerative medicine sector. Our product portfolio includes products where protein engineering and optimisation are combined with high-purity manufacture processes to develop first and best in class solutions.
Qkine is founded upon methods and scientific standards that continually pursue excellence, innovation, reproducibility and superior quality. We consider ourselves an integral part of the scientific endeavors and success of our customers and partners.
To achieve these, we
- continuously seek improvement by setting and achieving strategic quality objectives
- use a process approach and risk-based thinking to ensure full integration of our quality management system with our business processes to achieve our quality and service objectives
- are committed to providing the resources and training needed to ensure an effective quality management system and the guiding principles and work environment that facilitates our employees to meet and exceed our customers’ needs and expectations
- will satisfy all applicable regulatory requirements and good practises
As CEO of Qkine, I am committed to our quality principles and the quality management system which underpins our service to customers and the wider scientific community. I take full accountability and support other members of staff and stakeholders to achieve quality objectives and exceptional standards of customer service.
Dr Catherine Elton (CEO)
