Animal-free manufacture statement

At a glance | AOF Certificate | Process | Resources | Contact

Animal-free (AOF / ADCF) manufacture

Animal-free, animal–derived component free (ADCF), animal-origin free (AOF) and xeno-free mean different things to different manufacturers. Find out more about our manufacture process and the steps we take to ensure every stage is defined and controlled to provide an animal-free product.

We are always happy to help and answer any questions you have about specific products, processes and our animal-free ethos. Just email proteins@qkine.com or fill in our contact form.

Qkine proteins at a glance

  • Our products are manufactured in a dedicated animal-free laboratory in our ISO 9001: 2015 certified facility.

  • Most products are AOF, the few products that are ADCF are clearly indicated

  • Every lot tested in each QC assay

  • Manufactured in a microbial system (E.coli)

  • Lowest endotoxin level pass criteria in the industry

  • BSE/TSE free

  • No baculovirus used on-site or in our manufacture processes

What is the difference between animal-origin free (AOF) and animal-derived component free (ADCF)?

quick guide: AOF or 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.✔✗

Animal-free status certificates

Animal-free certificates, certificates of origin (manufacture details) certificates of analysis (quality and bioactivity information) and MSDS are available for all products – please request them here.

Manufacture 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.

Every stage of Qkine’s 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.

Molecular biology

  • 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)

Looking to implement animal-free recombinant proteins into your stem cell supply chains?

Read about the challenges pharma and biotech companies face as they look to switch to animal-free proteins in this article written by Dr Catherine Elton (CEO and Founder) and Beata Blaszczyk (one of our senior scientists) for Technology Networks.