Stability studies

What is an ICH stability study ?

The purpose of stability studies is to observe the behaviour of the product over time, in particular the degradation of the active substances in the drugs over time. The purpose is to verify that the quality of the drug remains within the defined or required standards throughout its lifespan.

To this end, several types of protocols can be implemented :

• Accelerated stability studies: the product is subjected to extreme climatic conditions in order to accelerate its degradation.
• Long-term (real-time) stability studies: the product is placed under normal storage conditions.

Stability study parameters that can be monitored by CDM Lavoisier

Our quality control and development laboratory teams are able to carry out the following studies :

• Monitoring of extractable volume, mass loss
• Active substance and excipient titration
• Particulate contamination : non-visible particles
• Monitoring of the progression of degradation products
• Microbiological stability studies (sterility tests, bacterial endotoxins)
• Container-content interaction studies

What is CDM Lavoisier’s storage capacity ?

CDM Lavoisier provides its customers with storage space in one of the controlled environment chambers on its premises (or at one of its partners) featuring the following characteristics :

• Temperature of 25°C/ 40% relative humidity (RH)
• Temperature of 40°C / ≤ 25% relative humidity (RH)
• Other conditions available on request.

In total, we have an ICH chamber storage area of 18 m3. This capacity is primarily used to store glass ampoules, plastic ampoules, glass vials, bags, etc…

When are ICH stability studies performed ?

Stability studies on drugs are carried out :

• During the development phase, prior to registration, in order to verify that the industrialisation process guarantees product stability over time which complies with the shelf life stated in the in the marketing authorisation (MA) dossier.
• As a rule, follow-up studies (called “on-going”) are carried out on a regular basis to monitor the stability of the manufactured batches, in accordance with GMPs.

The purpose of stability studies is to identify any instabilities in the quality of the drug during the shelf life of the batch and in particular :

• Loss in the amount of active substance
• Appearance of degradation products beyond acceptable standards
• Change in pH
• Microbiological degradation
• Presence of components from the container

Many factors can impact the stability of a drug :

• Interaction between the active substance and the excipients
• Temperature (heat or cold), too much light or not enough humidity
• Interactions between the container and content
• Exposure to oxygen

During the development phase, stability studies play a crucial role since they make it possible to define the target shelf life of the product. The adaptation of the industrial process (preparation, filling and sterilisation) and the chemical formulation of the product allow the active substance to remain stable over time.

Analytical monitoring of your injectable drugs

Our service offer goes far beyond the storage of your drug samples in climatic chambers. Our development laboratory and our quality control laboratory boast all the necessary expertise to ensure the monitoring of your products through various studies and controls :

• Analytical method development and validation
• Forced degradation studies
• Container-content interaction studies (extractables and leachables)
• Microbiology studies

All of these tests are conducted by our experts (engineers and laboratory technicians).

Each protocol implemented meets the specifications provided by the customer :

• Evaluation period and frequency
• Data taken into account in each analysis
• Product storage rules

In addition to analytical monitoring, CDM Lavoisier also offers a complete pharmaceutical contract manufacturing service for your injectable products :

• Glass ampoules from 1 to 20 mL
• Contract manufacturing of plastic ampoules from 0.4 to 20 mL
• Contract manufacturing of glass vials from 50 to 1,000 mL

Our manufacturing activities and our stability studies are carried out on our industrial site located in La-Chaussée-Saint-Victor in France.