Lot release testing includes physical and chemical testing to ensure that the product meets the defined specifications. It is not only a key component of the quality control process for biologics, but also the basis for drug development. Before a biological product can be released for use, sale or export, lot release testing must be performed. We have the ability to provide you with lot release testing to help your product eventually enter the market.
The importance of lot release testing for vaccines
As vaccine products are manufactured on a larger scale and the global supply chain grows, control of their quality and consistency is particularly important. Vaccine lot release testing is necessary to monitor critical quality attributes (CQA) and to ensure the continued production of high quality and well-characterized vaccine products. This is because vaccines are used in healthy normal populations. If strength of active components (potency) in a lot or batch of a vaccine is suboptimal, impact of using such a suboptimal lot will not be known for a very long period (years), because benefits of vaccination against a disease are not visible immediately and the protection is not on an individual basis. Similarly, if there are safety issues with a particular lot or batch of a vaccine, the impact will be devastating as a large number of healthy normal individuals (whole populations, usually pediatric population) receive vaccines.
Our lot release testing services include but are not limited to the following.
- Analyze finished products and bulk lots for purity, concentration, consistency, and identity.
- Testing of physicochemical properties, including appearance, color, pH, particulates, turbidity, extractable volume, osmolality, and moisture.
- Residual contaminant assays.
Why choose us
Our lot release testing specialists strictly adhere to current Good Manufacturing Practice (cGMP) requirements and optimize operations according to strict quality assurance standards. By utilizing our experienced experts to work with your team, Alfa Chemistry provides you with lot release testing solutions for all phases of vaccine manufacturing. If you have any questions related to lot release testing, please feel free to contact us. Alfa Chemistry is always your project partner.
Our products and services are for research use only and cannot be used for any clinical purposes.