Overview of analytical development services from method development & validation to process development & optimization offered by service providers.
Q1. What are analytical development services?
Analytical research and pharmaceutical development services include method development & validation, stability and degradation studies of APIs and other drugs, and preparation of technical dossiers for registration.
Pharmaceutical analytical techniques deal with different processes to identify or quantify a substance; the components of a pharmaceutical solution or mixture or the determination of the structures of chemical compounds used in the formulation of pharmaceutical products.
When existing compounds are used together in a new formulation, analytical method development services may be necessary in order to test the drugs’ interactions with each other, the formulation excipients or biological fluids.
Furthermore, drug substances and drug products may develop impurities at various stages of pharmaceutical development, transportation and storage which makes the pharmaceutical products risky to be administered. Therefore, these impurities must be detected and quantified via analytical testing methods.
From early candidate analysis to New Drug Application (NDA) or ANDA submission, analytical development services are applicable throughout a drug products development and production cycle. Robust GMP analytical testing methods are available for raw materials, in-process tests, drug substances, APIs / impurities as well as drug product development.
Analytical services normally included in the pharmaceutical industry, include: pharmaceutical development services and validation of stability indicating analytical methods, supply and execution of method transfer protocols, establishment of new product assay and degradation methods, graduated validation plans to suit the phase of drug development, cleaning validation, report writing and stability studies according to ICH.
Some other analytical development services are noted below:
- Compendial Analytical Testing (USP, EP, JP, BP)
- Raw Material Analytical Testing
- QP Release Testing
- Finished Product GMP Analytical Testing Methods
- Pharmaceutical Method Development and Validation
- Method Validation (ICH)
- Microbiological Analytical Testing Methods
Furthermore, pharmaceutical analysis contract services can play an important role in pharmaceutical development processes and GMP manufacturing of drug substances. Whether you need help with program specific method development or analytical testing, there are many companies that provide analytical development services using HPLC, LCMS or any number of immunoassays.
Analytical method development and validation is one of the leading strategies included in a contract providers analytical development services portfolio. Analytical method development and validation services are continuous and interconnected activities conducted throughout the drug development process. These activities are explored in detail in the subsequent question.
Q2. What is analytical method development and validation?
Analytical methods are intended to establish the identity, purity, physical characteristics and potency of drugs. Methods are developed to support drug testing against specifications during manufacturing and quality release operations, as well as long-term stability studies. Methods may also support safety and characterization studies or evaluations of drug performance.
Biopharmaceutical analytical method development and validation services are also critical to pharmaceutical development and achieving the reliable analytical data you need to reach your next development milestone. Furthermore, analytical method development and validation services play important roles in the discovery, development, and manufacture of pharmaceuticals.
Analytical Method Development Services
Analytical method development is the process of selecting an accurate assay procedure to determine the composition of a formulation. Effective analytical method development services ensure that laboratory resources are optimized, while methods meet the objectives required at each stage of drug development.
Approved methods establish clear limitations of application and verify that the process is resilient enough so that slight variations between operators or between laboratories do not have a material impact on results.
Analytical Method Validation
Method validation, as required by regulatory agencies at certain stages of the drug approval process, is defined as the process of demonstrating that analytical procedures are suitable for their intended use.
Analytical validation can be defined as the collection and evaluation of data generated from the process/method used during drug product development, whether it is commercial, experimental or a scientific study.
Any analytic methods one chooses for pharmaceutical method development need to be validated to ensure they’re scientifically sound. Validation ensures any analytic methods you’re using are measuring the substances in your product in the appropriate ranges. Therefore, biopharmaceutical analytical method development and validation services are important for product development and qualifying drug formulation processes.
Analytical Development and Validation Services include:
- Pharmaceutical method development for HPLC (HIC, SEC, PLRP), icIEF, CE-SDS, SDS-PAGE, ELISA, cell-based assays, and cleaning methods
- Qualification/Validation or transfer of methods
- Drug substance and drug product stability indicating assays
- Related substances, chiral purity, elemental impurity, and residual solvent analysis
- Remedial method validation/method lifecycle evaluation studies
- Preservative and stabilizing excipients assays
- Process validation support
- Extractables and leachables studies
- Method transfer
- Analytical method development services
- Specification pharmaceutical development services
- Reference standard qualification
- cGMP support for manufacturing
Q3.What is process development and optimization?
Process Development
Pharmaceutical process development encompasses all essential aspects of the drug formulation process from route and reagent selection to manufacture of the active compound. Drug formulation process development refers to the exercise of creating a route to manufacture a given drug product in a given quantity. It involves the selection and sequencing of process steps from a repertoire of unit operations.
Regulatory authorities expect product and process development to be based on sound scientific methods and principles, in combination with risk management tools which are applied throughout the development process. Drug formulation process development is completed prior to manufacturing APIs, generics, and biologics. Process development, process engineering and technology transfer teams work together to deliver quality products to consumers.
The product and process development team outlines the large scale manufacturing strategy, process engineering teams provide troubleshooting services as required, and finally technology transfer teams take the process from lab to commercial scale. The processes for manufacture of the bulk formulation and of the final dosage form are designed to optimize scale up and technology transfer activities.
Pharmaceutical Process Development Services for Drug Substances:
- Technology transfer
- Lab-scale process evaluation
- Product and process development
- Parametric studies (DoE)
- Pilot scale engineering runs.
Process Optimization
For delivering quality pharmaceutical products it is important to optimize product development and manufacturing activities. Process optimization can aid product development by providing a framework for process improvement.
Process optimization encompasses widely varying activities whose principal goal is to reduce costs by eliminating process steps, improving yields, shortening cycle times and producing higher-quality products. Companies with limited manufacturing capacity must look inside their manufacturing and logistic operations to squeeze more product from existing assets.
The key to a successful process optimization project lies in the expertise of the scientists and engineers doing the investigative work. There are no rules regarding process optimization when it comes to FDA compliance, other than the requirement that you have a reproducible process in place, and that you are following it each time.
Steps Involved in Process Optimization Includes:
- Defining the target product profile (quality, safety, efficacy, bioavailability, stability, etc.)
- Determining quality of active ingredients and excipients, and subsequently selecting the types and amounts required.
- Selecting an appropriate manufacturing process
- Identifying control strategies.
Process Optimization Services:
- Lab-scale GMP analytical testing methods for raw materials and products
- Development of a new manufacturing/processing line or making changes to an existing one
- Troubleshooting
- Raw material/component acceptance testing
- Validation of new material supplies
- Scale up of a technology
Q4. Who are the leading analytical development service providers?
There are various companies offering analytical development services including analytical method development services, validation services, program specific method development, process development & optimization and other biopharmaceutical analytical method development and validation services.
Proveris Scientific
Proveris Scientific can help every step of the way from formulation & device screening, and method development to regulatory submission & out of specification (OOS) investigations for orally inhaled and nasal drug products (OINDPs).
Proveris offers full method development and analytical services for all spray characterization tests—spray pattern, plume geometry and DSD. Proveris-certified methods can be transferred through all stages of the development cycle from early development through manufacturing QC.
Skyepharma
Full-service CDMO Skyepharma Production S.A.S. (Skyepharma) offers analytical support services in all stages of product development and manufacturing. These services include analytical development and quality control of packaging items, raw materials, finished products (chemical and microbiological analysis) based on European and US regulations.
At skyepharma product development is closely supported by an experienced analytical team during every phase of the development process. They are able to develop analytical methods in a limited time, from bibliography study, screening parameters and conditions to sample preparation and assessment of robustness.
ChemWerth Inc
Through exclusive development and partnerships with API manufacturers, ChemWerth provides expertise in product selection & development; analytical and regulatory services and strong project management to ensure the highest standards of quality.
Through ChemWerth’s own laboratory, they can provide analytical support services from program specific method development to methods validation. All projects are conducted under cGMP conditions and are supported with DMF filings or product registration.
ZCL Chemicals
ZCL has an analytical development laboratory that provides analytical support services to their synthesis group. Major activities include: Analytical method development & validation for RM, WIP & finished products, OVI method development & method validation, impurity profile studies, etc.
Highly qualified professionals with the scientific bent of mind are working in product development, analytical development and intellectual property rights at ZCL Chemicals.
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