Development, optimization and qualification phases are crucial during the drug life cycle. At Selvita we work in efficient and flexible manner, using the best industry practices, in order to support our clients at this important process stage. Our team consists of industry experts with a thorough understanding of the process and long-standing professional expertise in the field, complemented by appreciation of the latest analytical and bioanalytical chemistry trends.
We support our partners at various drug development stages, using a wide range of laboratory techniques. Starting from method development from scratch, method optimization via their full qualification under cGMP standards and batch release testing. Such activities are complemented with proven track record of successful method implementation within the Customers’ drugs life cycle in quality manner.
Documentation provided upon each drug development step is based on templates available at Selvita or adapted to Customer’s requirements. We follow precisely the respective ICH guidance and general pharmacopeial requirements (methods and monographs); Customer’s methods and specifications, as well as internal procedures.
In order to constantly monitor the process and discuss further action steps with the Client, we offer reoccurring teleconferences, showcasing project’s progress.
Analytical and bioanalytical method development stage is utilized for medicinal product when there is no efficient method available for e.g., purity determination or assay; when the final product is a mixture of different active ingredients, or the existing method described in the guidelines is obsolete or does not meet Clients’ requirements. We check several crucial parameters at that stage, like specificity/selectivity, linearity, precision, accuracy/recovery, LOQ/LOD. The developed method is fully ready for the validation stage.
For method development, we use either HPLC/UHPLC or GC(HS). Our analytical department is equipped with liquid chromatographs Agilent 1260 Infinity II and 1290 Infinity II (Agilent Technologies), Ultimate 3000 RS UHPLC and Ultimate 3000 SD HPLC (Thermo Fisher Scientific) with DAD-UV, PDA, FLD, CAD, ELSD, MS detectors, as well as headspace gas chromatographs with FID, MS detectors.
There are some cases when methods exist and optimization is needed to meet the current standards and validation criteria. Selvita utilizes its professional expertise and experience gained while performing over 100 projects in various techniques and matrixes each year.
Once the method is developed and optimized, it can be validated, which is mandatory action, if the method will be potentially used for testing drug product. Implementing a new method at analytical laboratory is crucial in the method’s life cycle, therefore it is performed under the laboratory management and quality assurance unit supervision.
Validation is always conducted in line with approved protocols, consistent with ICH guidelines, which can be prepared either according to Selvita’s standard operating procedures (SOPs) or the client’s SOPs. Once the validation is complete, all results are described in validation report, which then should be approved by the Client.
For the compendial methods or the method with validation status, method verification is performed. Method verification does not require formal protocols and can have limited range of parameters tested, otherwise, it is carried out in exactly the same way as validation.
Method transfers from the company to another laboratory is also closely supervised. Transfers and methods validations are conducted according to the current cGMP regulations and approved protocols.
All experiments required for such operations are conducted by our experienced analysts and supervised by the laboratory management. The forementioned guarantees that the (bio)analytical method works accurately and correctly in any workplace that is being implemented.