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Method validation Related information

Method Development and Method Transfer in Bioanalytical Assays

In the realm of pharmaceutical research and development, the significance of method development, validation, and transfer cannot be overstated. These fundamental aspects ensure the reliability, accuracy, and consistency of bioanalytical assays throughout the drug development process. At Biotrial, we pride ourselves on our expertise in these critical areas, striving to meet and exceed the rigorous criteria set by regulatory bodies and the pharmaceutical industry itself.

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Method Development: The Backbone of Drug Development

At Biotrial, we understand that the success of any drug development project hinges on the precision and efficacy of the analytical methods employed. Method development is the foundation upon which the entire process rests. Our team of experts is dedicated to developing and refining these methods, ensuring that they meet the exacting criteria for sensitivity, performance, and efficiency. The objective is to streamline the drug development process, enabling faster and more reliable results.

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Analytical Method Development and Validation: Meeting Regulatory Standards

Method development is followed closely by rigorous analytical method validation. Regulatory agencies demand stringent criteria for method validation to ensure the accuracy and reliability of data generated. We specialize in the complete spectrum of analytical method development, from the initial concept to the comprehensive validation process. Our laboratory is equipped with state-of-the-art technology, enabling us to develop and validate methods for a wide range of compounds, from small molecules to biologics.

Analytical Method Transfer: Ensuring Consistency in Manufacturing

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Method transfer is the bridge that connects laboratory-developed methods to the manufacturing environment. This process must be executed with precision to maintain the integrity and stability of the methods. Our experts guide you through every step of method transfer, ensuring that the methods seamlessly transition to the manufacturing setting while adhering to the established criteria. This ensures the consistent quality of the product throughout its lifecycle.

Clinical Samples and Assays: Meeting Strict Criteria

The clinical phase of drug development necessitates highly accurate and validated assays. Regulatory bodies demand adherence to stringent criteria in this phase. Biotrial specializes in developing and validating clinical assays, ensuring that they meet the demanding standards set forth by regulatory authorities. Our assays are meticulously designed and validated to provide reliable and meaningful data during clinical trials.

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Bioanalytical Method Validation for Regulatory Compliance

Our laboratory specialists are well-versed in the rigorous requirements of regulatory agencies. We meticulously validate our assays to ensure that they meet the stringent criteria imposed by agencies such as the FDA and EMA. Our extensive experience spans several decades, with a track record of successfully supporting regulatory filings, including INDs, NDAs, and aNDAs.

Sample Receiving and Data Analysis: The Backbone of Quality

Within the laboratory, we uphold the highest standards for sample receiving, processing, and data analysis. Adherence to strict criteria is essential to guarantee the accuracy and reliability of the results. Our laboratory is equipped with advanced technology to manage a wide range of samples, ensuring that data analysis is consistently accurate and meaningful.

Innovative Research & Development

Biotrial doesn’t stop at analytical method development and validation. We are at the forefront of innovative drug development, continuously pushing the boundaries of what is possible. Our expert team specializes in developing new methods, ensuring that they meet the highest standards, and supporting your projects as they evolve.

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Vitamins

Exenatide (Byetta), Pramlintide (Symlin), Thiostrepton: very large molecules (peptide), high complexity, low limit of detection, challenging chromatography and sample preparation

Vitamins & Hormones: Doxercalciferol, Vitamin D and analogs, Paricalcitol, Estrogens: significant endogenous levels, low response in mass spectrometry, low limit of detection

Molecule
Antibodies

Innovative Molecule: stability, range of concentration, recovery issues, wide range of matrices (blood, CSF, pleural fluid, tissues, etc), toxicokinetic, Multiple/Single Ascending Dose, chirality

Antibodies and anti-drug antibodies & Generic drugs:  pharmacokinetic, bioequivalence, bioavailability

Compounds Development

Our highly trained R&D scientists at Biotrial utilize the latest techniques, and even in cases where custom synthesis is not an option, they are adept at finding novel solutions and successfully progressing to assays with high client satisfaction and appreciation.

  • Small and large molecules including peptides, proteins, and antibodies.
  • Drug development program support from exploratory and Early Stage Clinical samples (SAD/MAD)
  • Proof of Concept
  • First-In-Human clinical study
  • Drug-drug interactions
  • Food Effect
  • Bioavailability
  • Bioequivalence and Therapeutic Drug Monitoring (Orphan Drugs). 
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Collaboration and Method Improvement: A Continuous Process

We firmly believe in collaboration throughout the drug development process. Our experts work closely with your team to ensure that methods are continually enhanced to meet the evolving criteria of your project. Collaboration is the key to success, and we’re committed to supporting you at every stage.

Quality Assurance in Analytical Methods: Excellence in Every Aspect

Quality assurance is not limited to a single phase but is woven into every aspect of the drug development process. Methods must meet stringent criteria for accuracy, reliability, and consistency. Our commitment to quality is unwavering.

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Continuous Method Enhancement and Support: Nurturing Success

Our dedication to method development, validation, and transfer extends beyond the initial phases. We provide ongoing support to ensure that your methods are continually enhanced to meet the evolving criteria of your project. This comprehensive support is the cornerstone of our commitment to your success.

In conclusion, method development, validation, and transfer are the pillars of success in drug development. Biotrial stands ready to be your trusted partner in these critical areas. With our seasoned team, cutting-edge technology, commitment to innovation, collaboration, and ongoing method improvement, we are your dedicated ally on your drug development journey. Your success is our mission.

Approaches to Method Transfers

Leveraging our extensive expertise, we collaborate closely with our clients to identify the most effective method transfer strategy. Our approach blends regulatory guidance with a comprehensive risk analysis. The available transfer options generally encompass :

Comparative Testing

This method stands as the most prevalent approach, necessitating the testing of uniform batches of material by both the sending and receiving laboratories. The transfer protocol outlines the specific procedural details, the designated samples, and the acceptance criteria.

Covalidation

In scenarios where GMP testing requires the involvement of multiple laboratories, covalidation becomes the most efficient transfer strategy. In this context, the receiving laboratory becomes an integral part of the validation team and conducts intermediate precision experiments to generate data for assessing reproducibility.

Revalidation

If the originating laboratory is unavailable for comparative testing, revalidation often emerges as the optimal solution. In this case, a risk-based approach guides the determination of which aspects of the original validation need to be re-performed by the receiving laboratory.

Transfer Waiver

There are situations where the need for a transfer can be waived based on the receiving laboratory’s experience (current utilization of the procedure with another product, transfer of personnel, etc.), or if the procedure being transferred is already specified in the USP-NF. In such instances, a verification process should be applied.

Added values

Support

Collaboration

Our R&D team is always available to provide support to our validation scientists, including confirming elements of the assay under validation.

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Validation Types

Full Method
Partial Method
Cross-Validation

Optimization

Parameter Optimization

Analyte Stability, Limits of Detection / Quantitation, Linearity / Range, Robustness, Accuracy, Precision

Equalizer

Parameter Optimization

Reference Standards, Critical Reagents, Calibration Curve, Quality Control Samples, Selectivity/Specificity

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