Small Molecules: Method Development, Validation, And Transfer –Selvita
by Liz Seyi Digital marketing managerDevelopment,
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the existing method described in the guidelines is obsolete or does not meet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.
Sponsor Ads
Created on Sep 20th 2022 06:01. Viewed 155 times.