When it comes to freezing the clock on your cells, quality matters.
At Acorn Biolabs we strive for operational excellence. The way we collect, analyze, and store human hair follicles is done with strict adherence to Current Good Manufacturing and Tissue Practices (cGMP/cGTP).
For most, cGMP/cGTP compliance is not a phrase that comes to mind. For those that deal with it daily, it is synonymous with a never-ending mountain of paperwork.
So why is it such an important part of Acorn’s cell preservation service?
For any respectable biotechnology or pharmaceutical company, this phrase is at the core of every practice. Poor quality products are not only a health hazard but a waste of money for governments, companies, and individual consumers https://asq.org/quality-resources/cost-of-quality. A bad quality product could either cause damage to someone’s health or have no result at all. In some circumstances, it can be a matter of life and death!
This is why the World Health Organization (WHO) and governments have established a set of standards and guidelines. These guidelines ensure that companies provide documented proof that the production of pharmaceutical drugs and biologicals is done with extreme care!
Think about it this way, as a consumer, you can feel, see, and smell a product. Yet you cannot know if it is safe and effective before you try it. You read the warning labels, the instructions, and you try it out for yourself. In some cases, the product works, and in other cases, it does not. The consumer may develop long term health problems. So, quality must be built into the process at every step. This way, consumers can put their trust in a product.
With that in mind, how do we at Acorn ensure that the cryopreservation of every consumer’s hair follicles follows these guidelines?
It is with these 10 points of quality:
- It all starts with the paper: our starting point for quality is our quality manual. The manual sets out our intentions for our quality management system. It is the heart of our quality process.
- SOP’s are the core: We have hundreds of standard operating procedures (SOPs). SOPs provide step by step instructions for work processes.
- Living & breathing documentation: Our SOPs are not stagnant. SOPs get updated making them a living, breathing set of documents.
- Our facility: Our state-of-the-art facility, with ISO7 clean rooms, is of the most secure, safe, and high-quality bio-repositories in the world.
- Maintenance: Our cleanroom is 350,000 times cleaner than the world outside of your window! It is also 10 times cleaner than a hospital surgical room. This prevents any contamination from entering your sample during processing.
- Our people: Our processing technicians have backgrounds in cellular and molecular biology and other STEM disciplines. This gives them a deep-rooted understanding of the processes we perform.
- Advance Equipment: Within our state-of-the-art facility, we have vapor-phase cryogenic stainless-steel storage solutions and control rate freezers that house thousands of samples at any given time.
- Viability Report: Unique to Acorn, the report ensures clients that there is an adequate quantity of live cells. Regenerative medicine applications use only live cells.
- Risk Management: A systematic process that allows for understanding and identification of underlying problems early on. Which means there are fewer surprises for everyone!
- Continual Improvement- To bring quality and innovation to healthcare, we look to the future in an ongoing cycle of continuous improvement.