Biological and Biotech Products
ICH Q5C - Stability Storage and Testing
Today`s development of medicine is advancing with many Pharmaceutical and Biotech companies researching and developing biological medicine to help fight disease.
Biologic and Biotech drug products require controlled storage and testing from inception through to manufacture and final product release. Biologics require a range of stability conditions from cold chain -80°C, 70oC, -40oC, -20oC and 5oC up to standard ICH 25oC/60%RH, 30oC/65%RH and 40oC/75%RH for accelerated testing. Stress testing also has to be considered by use of temperature, light and freeze/thaw studies.
In designing a stability testing protocol, conditions should be selected carefully and based on each product individually.
Strictly defined storage temperatures are required for most biologicals. The real time and temperature studies can be carried out at the proposed final storage temperatures and the expiry dates are generally based on this data.
In many cases, humidity is not a major concern as the product containers protect against any humidity ingress, however the integrity of the container must demonstrate protection against high and low humidity levels. If such containers are not used, then stability humidity data must be provided.
Accelerated & Stress
Although expiration of a product is based on the real time temperature data, storing and testing at accelerated conditions can provide supporting data to help establish the shelf life of the product along with providing information that may assist in developing the product, guidance for proposed formulation and manufacturing changes which will give a clearer picture of how the product may degrade over time.
While the use of photostability testing of a product has to be taken on a case by case basis, the use of this testing can represent real life storage conditions, represent accidental exposure to light and ambient temperatures, indicate any degradation patterns and assist in the choice of final packaging and orientation.
While determining the shelf life of the product is paramount, the opportunity for a condition excursion can present itself during transportation of the final product. It is therefore pertinent to carry out transport / cycling studies at the conditions that the product may incur during air, sea and land shipping.
How can we help
As the production of Biotech and Biological products is increasing around the globe, we at Source BioScience are in a position to assist all manufactures with their Stability Storage and Testing requirements. Source BioScience have Stability Storage facilities in Tramore (Ireland), Rochdale (England), two facilities in the United States (Atlanta and LA) and Livingston (Scotland) which includes Analytical Testing as well as stability storage.
Our facilities in the UK and Ireland already accept and store products from customers in many countries around Europe and our US facilities are positioned to assist companies in the USA, Canada, South America, Japan and even Australia.
With multiple walk-in, reach-in chambers and cabinets at each site offering the ‘standard’ ICH conditions (5°C, 25°C/60%RH, 30°C/65%RH, 30°C/75%RH and 40°C/75%RH) along with minus conditions (-20°C, -40°C, -70°C & -80°C), bespoke and ‘unusual conditions’, cycling chambers and photo-stability we can meet your expectations and requirements.
All our sites maintain GMP compliance through our rigorous Quality Systems and all data is treated with the strictest confidence.
The chamber conditions are monitored using independent sensors which feed the temperature and humidity (where applicable) measurements back to 21CFR, part11 compliant data loggers and this is held on the datalogger hard drive along with being backed up to servers on our secure IT network. The data loggers will also call out our fully trained team if there is any excursion during the day or night giving you 24-hour peace of mind.
Each site has engineers available on 24-hour call-out to sort out any issues with the chambers should they occur.
All product received for storage at a Source BioScience site is tracked through our LIMS system from receipt to return and storing with us takes away the day to day hassle of running a Stability Trial.
If you prefer to run your stability trials on your own site, we at Source BioScience, we have been designing, manufacturing, installing and commissioning GMP and FDA, compliant controlled environmental equipment for stability storage testing for over twenty-five years.
In this time, we have undertaken installations across the UK, Ireland and the United States supplying equipment to many of the top pharmaceutical, Biotech and Medical Device companies and well as various contract laboratories.
This activity is co-ordinated from our Rochdale facility (England) where we have the necessary mechanical, electrical and refrigeration expertise to ensure we offer a robust and reliable piece of equipment. Every project is assigned a Project Manager who will have full responsibility and will be your primary point of contact.
We would of course welcome you to our Rochdale facility so that we could you show you what we do or alternatively visit our Stability Storage sites in Ireland or the US to view fully built chambers in action.
For further information and prices please contact us or call +44(0) 115 973 9012