Advanced Analytical Chemistry in Drug Analysis Training Course

Advanced Analytical Chemistry in Drug Analysis Training Course

Introduction

The field of Advanced Analytical Chemistry is experiencing a rapid evolution, driven by the increasing complexity of drug discovery, development, and manufacturing. Advanced Analytical Chemistry in Drug Analysis Training Course is specifically designed to provide professionals with the in-depth knowledge and hands-on expertise required to master the latest techniques in drug analysis. We'll delve into the foundational principles and practical applications of cutting-edge analytical methods, including high-performance liquid chromatography (HPLC), mass spectrometry (MS), and nuclear magnetic resonance (NMR). The curriculum focuses on real-world scenarios, ensuring that participants can confidently apply their skills to solve complex analytical challenges, from impurity profiling and stability testing to pharmacokinetic analysis and quality control.

Our program stands out by bridging the gap between theoretical knowledge and practical application, using a blended learning approach that incorporates interactive lectures, guided laboratory sessions, and case study analysis. Participants will gain a comprehensive understanding of method validation, data integrity, and regulatory compliance (e.g., cGMP, ICH guidelines), which are crucial for ensuring the safety and efficacy of pharmaceutical products. By mastering these advanced techniques, you'll be well-equipped to contribute to innovation in the biopharmaceutical industry and play a key role in safeguarding public health.

Course Duration

10 days

Course Objectives

Upon completion of this course, participants will be able to:

1. Master advanced chromatographic techniques like UPLC and 2D-LC for complex drug separations.
2. Apply mass spectrometry for the structural elucidation and quantification of drug substances and metabolites.
3. Perform impurity profiling and degradation studies using hyphenated techniques.
4. Validate and optimize analytical methods in compliance with ICH guidelines.
5. Utilize NMR spectroscopy for drug characterization and bioanalysis.
6. Analyze biological matrices for pharmacokinetic and toxicokinetic studies.
7. Implement Quality by Design (QbD) principles in analytical method development.
8. Ensure data integrity and regulatory compliance in pharmaceutical analysis.
9. Develop and execute robust quality control and quality assurance protocols.
10. Troubleshoot common issues in analytical instrumentation and laboratory workflows.
11. Interpret complex analytical data using chemometrics and statistical software.
12. Analyze biologics and large molecule drugs using LC-MS/MS and other advanced techniques.
13. Stay current with emerging trends like high-throughput screening and miniaturization in drug analysis.

Organizational Benefits

• Equips teams with the skills to accelerate drug discovery and development by improving analytical speed and accuracy.
• Ensures that analytical methods meet global regulatory standards (cGMP, FDA, EMA), reducing the risk of recalls and non-compliance issues.
• Enables efficient method development and troubleshooting, minimizing downtime and increasing laboratory throughput.
• Optimizes resource allocation and reduces errors in analysis, leading to lower operational costs.
• Fosters a culture of excellence and innovation, positioning the organization as a leader in the pharmaceutical and biopharmaceutical sectors.
• Invests in employee skills, boosting morale and retaining top analytical talent.

Target Audience

1. Analytical Chemists in the pharmaceutical and biotech industries.
2. R&D Scientists involved in drug discovery and development.
3. Quality Control (QC) and Quality Assurance (QA) professionals.
4. Pharmacists and toxicologists seeking advanced analytical skills.
5. Recent graduates in chemistry, biochemistry, or a related field aiming for a career in drug analysis.
6. Laboratory Managers and Supervisors.
7. Regulatory Affairs Specialists requiring a deeper understanding of analytical data.
8. Contract Research Organization (CRO) scientists performing drug analysis services.

Course Modules

Module 1: Fundamentals of Advanced Drug Analysis

• Principles of pharmaceutical analysis and cGMP compliance.
• Method validation essentials: specificity, accuracy, precision.
• Impurity profiling and degradation product analysis.
• Statistical tools for analytical data interpretation.
• Case Study: Analyzing a drug product for unknown impurities and degradation products to support a regulatory filing.

Module 2: Advanced High-Performance Liquid Chromatography (HPLC)

• UPLC and micro-HPLC for rapid analysis.
• 2D-LC for separating complex mixtures.
• Stationary and mobile phase selection for challenging analytes.
• Troubleshooting common chromatographic issues.
• Case Study: Developing a robust UPLC method for a multi-component drug formulation.

Module 3: Principles and Applications of Mass Spectrometry (MS)

• Fundamentals of ion sources (ESI, APCI) and mass analyzers
• Tandem MS/MS (MS²) for structural information.
• High-resolution mass spectrometry (HRMS) for accurate mass measurement.
• Quantitative analysis using MS.
• Case Study: Using HRMS to confirm the identity of a new drug candidate and its metabolites.

Module 4: Hyphenated Techniques in Drug Analysis

• LC-MS/MS for simultaneous separation and detection.
• GC-MS for volatile and semi-volatile compounds.
• CE-MS for separating chiral and large molecules.
• Data analysis from hyphenated systems.
• Case Study: A bioanalytical study using LC-MS/MS to quantify a drug in plasma samples.

Module 5: Spectroscopic Methods for Drug Characterization

• NMR Spectroscopy for structural elucidation and purity assessment.
• FTIR and Raman Spectroscopy for solid-state analysis and polymorphism.
• UV-Vis Spectroscopy for quantification and dissolution testing.
• Integration of spectroscopic data with chromatographic results.
• Case Study: Identifying different polymorphs of an active pharmaceutical ingredient (API) using FTIR and solid-state NMR.

Module 6: Bioanalysis and Pharmacokinetics

• Sample preparation for biological matrices (blood, urine, tissue).
• LC-MS/MS methods for drug quantification in biological fluids.
• Pharmacokinetic and toxicokinetic study design and data interpretation.
• Regulatory requirements for bioanalytical method validation.
• Case Study: A preclinical study to determine the bioavailability of a new drug from animal data.

Module 7: Impurity and Degradation Product Analysis

• Forced degradation studies and stress testing.
• Identification and quantification of impurities.
• Impurity profiling using HPLC-UV and LC-MS.
• Genotoxic impurities and regulatory considerations.
• Case Study: Investigating the cause of an unexpected impurity spike in a drug batch.

Module 8: Quality by Design (QbD) in Analytical Method Development

• Principles of QbD and design of experiments (DoE).
• Defining the Analytical Target Profile (ATP).
• Assessing and controlling method variability.
• Developing a method control strategy.
• Case Study: Designing a robust analytical method for a complex API using DoE.

Module 9: Regulatory Compliance and Data Integrity

• ICH guidelines (Q2, Q3) and their practical application.
• 21 CFR Part 11 and electronic records.
• Ensuring data integrity throughout the analytical workflow.
• Auditing and validation of analytical systems.
• Case Study: A mock regulatory audit of a QC laboratory to ensure compliance with data integrity regulations.

Module 10: Analysis of Biopharmaceuticals

• Protein and peptide analysis using LC-MS.
• Oligonucleotide and antibody-drug conjugate (ADC) characterization.
• Peptide mapping and glycosylation analysis.
• Mass spectrometry for large molecule intact mass analysis.
• Case Study: Using LC-MS to confirm the primary structure and modifications of a monoclonal antibody.

Module 11: Chemometrics and Advanced Data Analysis

• Introduction to multivariate data analysis.
• Principal Component Analysis (PCA) for data visualization.
• Partial Least Squares (PLS) regression for method calibration.
• Using statistical software for data interpretation.
• Case Study: Analyzing a complex dataset from a stability study to predict shelf-life and identify key degradation pathways.

Module 12: Solid-State Analysis and Material Characterization

• X-ray powder diffraction (XRPD) for crystallinity and polymorphism.
• Differential Scanning Calorimetry (DSC) and thermogravimetric analysis (TGA).
• Particle size analysis and morphology.
• Connecting solid-state properties to drug product performance.
• Case Study: Characterizing the solid-state form of a drug to predict its dissolution and bioavailability.

Module 13: Advanced Laboratory Techniques & Automation

• Automated sample preparation and liquid handling systems.
• High-throughput screening and miniaturization.
• Robotics in the analytical laboratory.
• Modern chromatography data systems (CDS) and LIMS.
• Case Study: Automating a routine QC assay to increase throughput and reduce analyst time.

Module 14: Forensic and Clinical Drug Analysis

• Toxicology screening and drug-of-abuse testing.
• Analyzing drugs and metabolites in forensic samples.
• Clinical applications of analytical chemistry.
• Case study: A forensic toxicology case involving the identification and quantification of illicit substances in a blood sample.

Module 15: Emerging Trends in Analytical Chemistry

• Artificial Intelligence (AI) and Machine Learning in method development.
• Mass spectrometry imaging (MSI).
• Microfluidics and Lab-on-a-Chip technologies.
• Future of analytical instrumentation.
• Case Study: Exploring how AI can optimize chromatographic method development for a new drug.

Training Methodology

Our training methodology is designed for maximum engagement and practical skill acquisition, combining theoretical instruction with extensive hands-on experience. It includes:

• Interactive Lectures: Led by industry experts with a focus on real-world application.
• Hands-on Lab Sessions: Guided practice with state-of-the-art analytical instruments.
• Case Study Analysis.
• Problem-Based Learning.
• Workshops & Seminars: Deep dives into specific techniques and regulatory topics.
• Mentorship & Q&A.

Register as a group from 3 participants for a Discount

Send us an email: [email protected] or call +254724527104 

Certification

Upon successful completion of this training, participants will be issued with a globally- recognized certificate.

Tailor-Made Course

 We also offer tailor-made courses based on your needs.

Key Notes

a. The participant must be conversant with English.

b. Upon completion of training the participant will be issued with an Authorized Training Certificate

c. Course duration is flexible and the contents can be modified to fit any number of days.

d. The course fee includes facilitation training materials, 2 coffee breaks, buffet lunch and A Certificate upon successful completion of Training.

e. One-year post-training support Consultation and Coaching provided after the course.

f. Payment should be done at least a week before commence of the training, to DATASTAT CONSULTANCY LTD account, as indicated in the invoice so as to enable us prepare better for you.