Quality commitment 1

Certified animal origin-free proteins with full traceability

Qkine manufactures recombinant proteins in a dedicated animal-free laboratory located in an ISO 9001:2015 certified facility. Our manufacturing process ensures every stage is defined and controlled to provide an animal-free product.

High-quality, animal origin-free proteins manufacturing

All our products are AOF (animal-origin free). Each production lot undergoes rigorous testing across various quality control assays to ensure a consistently high level of quality for every lot. This includes the industry’s lowest endotoxin level pass criteria, as well as mycoplasma and sterility testing, as standard. Additionally, our products are free from BSE/TSE.

Proteins are manufactured in an E. coli microbial expression system, with no use of baculovirus on-site.

animal origin-free recombinant protein manufacturing

Why use Qkine animal origin-free growth factors and cytokines for your stem cell cultures?

  • Consistency & reliability enhanced

Utilizing animal-free recombinant proteins eliminates variations arising from trace animal components, promoting improved cell culture consistency. All our recombinant proteins mitigate the risk of contamination by mammalian pathogens, enhancing the reliability of cell products.

  • Excellent lot-to-lot consistency

All Qkine growth factors and cytokines have exceptional lot-to-lot consistency. Every lot is checked during a stringent QC process to ensure it has the same bioactivity as prior lots and to ensure reproducibility.

  • High level of purity with the lowest endotoxin level

We guarantee >98% purity due to limitations of the assays, but we are confident that the true result is higher. To ensure purity, we always run an overloaded gel with 7 µg of protein to ensure that we can not visually detect any contaminants, aggregates, or degradants.

  • High biological activity

At Qkine, we test and validate the biological activity of all our growth factors against other suppliers’ proteins to ensure that we provide you with proteins of the highest level of biological activity.

  • Cost-effectiveness & scalability

Animal-free manufacturing offers greater supply chain stability and contributes to higher lot-to-lot consistency and reproducibility. This ensures that researchers can scale up production relying on consistent quality, reducing the need for extensive quality control measures and optimizing resource utilization.

Discover animal-free recombinant proteins today
to improve reproducibility in your cultures

Animal-free manufacturing process control

As part of our ongoing commitment to quality in every aspect of the company, animal-free production is taken into consideration from the very earliest planning stages of design and development. Before being incorporated into a procedure, newly-sourced materials must be reviewed and approved by our Quality team.

We continuously work with our suppliers to confirm and certify that the chemical components used within the manufacture of Qkine products are derived from non-animal and non-human sources and that the processes and components used in their own manufacture are animal-free.

ISO9001:2015 certified mark of trust with certificate number FS 747253

Every stage of the Qkine animal-free protein manufacturing employs Standard Operating Procedures (SOPs). SOPs are fundamental to assure consistency from lot to lot and guarantee the highest quality of products.

Qkine is ISO 9001:2015 certified for development, manufacture, and supply of proteins and related products.

Every component used during the manufacture of our products is assessed by our Quality team.

Animal free manufacturing process
  • DNA is transformed into competent bacterial cells which are generated using animal-free media
  • Fermentation processes follow approved SOPs
  • Raw materials and labware are animal-free* (see below)
  • All raw materials are traceable through batch records
  • All batches of bacteria are grown in animal-free media
  • Dedicated animal-free fermentors are employed
  • Equipment cleaning procedures have been validated
  • Purification processes follow approved SOPs
  • Dedicated animal-free columns are used* (see below)
  • Column cleaning procedures have been validated specifically for animal-free manufacturing
  • All labware which comes in contact with the product is animal-free* (see below)
  • Bulk purified proteins are filtered using certified animal-free filters
  • Line clearance procedures ensure all relevant areas are cleared of materials from the previous operation before filling commences
  • Lyophilization is conducted in a dedicated animal-free equipment

Any raw materials that are manufactured by fermentation, are considered animal-derived component free if no high or medium infectivity tissues are contained in the culture medium, as specified by the WHO Tables on Tissue Infectivity Distribution in Transmissible Spongiform Encephalopathies WHO/EMP/QSM/2010.1.

Although plastics themselves are produced from synthetic sources, additives manufactured from bovine tallow are often employed during the manufacture process to improve material properties and to aid in the processing of raw polymers. All plastics used directly within the Qkine manufacturing process are certified in compliance with the European “Note for guidance on minimizing the risk of transmitting animal spongiform encephalopathy agents via human and veterinary products (EMA/410/01-Rev 3)”.

Certain products in the FGF family of growth factors require a derivatized chromatography matrix for purification. Following a thorough review of the regulatory support file for this matrix, we have concluded that it is appropriate for use in our animal-free laboratory. This chromatography matrix is manufactured in accordance with cGMP and is extensively characterized by the manufacturer. The components are of therapeutic grade and comply with the European guidance note (EMA/410/01-Rev 3).

  • Certificate of Analysis is available upon request (request form below)
  • Animal free manufacture certificates /certificate of Origin are available upon request (request form below)

Animal-free certificates, certificates of origin (manufacture details), certificates of analysis (quality and bioactivity information) and MSDS are available for all products. Please request any documentation below.

Featured resources

Nine-point Quality Commitment

Animal origin-free proteins manufacturing

Qkine is committed to manufacturing bioactive proteins of the highest quality to enhance scientific outcomes and improve reproducibility.

Quality policy

Qkine ISO 9001: 2015 certification

Learn more about our quality management system implemented to comply with the requirements of ISO 9001:2015.

Quality control

Animal origin-free proteins quality control

To ensure results are reliable and reproducible every time, we have stringent quality control procedures in place.

Contact our expert team

Our dedicated team of stem cell specialists is available to answer any queries and to give expert support when required.

Quick guide: AOF or ADCF?

Difference between animal-origin free (AOF) & animal-derived component free (ADCF)AOFADCF
Raw materials used directly in the product or as a starting material (e.g. E.coli growth media) are not derived from animal or human tissue, cells or body fluids
Raw materials used directly in the product or as a starting material do not contain animal or human tissue, cells, or body fluids at any stage of their manufacture process
Consumables used within the Qkine production process (e.g. filters) are not derived from animal or human tissue, cells or body fluids and no animal or human tissue, cells or body fluids are used at any stage of their manufacture process.

Contact us

Our dedicated team of stem cell specialists is available to help and answer any questions you have about specific products, processes and our animal-free ethos.