Delivering Training Solutions for Pharmaceutical Analysis
Mourne Training Services Ltd - Delivering training, consultancy and auditing services for pharmaceutical analysisAnalytical method validation training course for pharmaceutical analysis by Mourne Training Services Ltd (MTS)

This course is available in two versions, you can choose from either the Pharmaceutical version (test methods used for small molecules) or the Biopharmaceutical version (test methods used for large molecules, typically derived from biological or biotechnology processes). The information below is designed to help you decide which version of the course will be most suitable for your needs.

The analytical techniques used to test traditional small molecule pharmaceuticals are typically different to those used for testing biopharmaceuticals, also known as biotherapeutics. Therefore, the key difference between the two versions of this course is that the examples and case studies used in the course are tailored to these different types of medicinal products. Additionally, since the typical acceptance criteria which is applied differs, the most relevant guidance can be provided to attendees.

Method Validation & Transfer Courses

Validation & Transfer of Methods for

Course option 1: Pharmaceutical, or

Course option 2: Biopharmaceutical Analysis

Course option 1: Pharmaceutical Analysis 
(Suitable for small molecules)

Why Choose this Version?

If the methods that you want to validate, verify or transfer are for traditional, small molecule (typically < ~2000 Daltons) pharmaceutical products, then this is the right version for you. It will also be applicable for the majority of testing methods for raw materials, and methods associated with cleaning validation.

Includes (but is not limited to):

- Assay (of drug content or other components), e.g., RP-HPLC, GC
- Related substances including stability indicating methods, e.g., RP-HPLC
- Elemental impurities, e.g., ICP-MS, ICP-OES
- Residual solvents, e.g., GC
- Low level impurity methods such as leachables and extractables, and potential gentoxic impurities, e.g., LC-MS, GC-MS
- Dissolution testing
- Water content, e.g., KF

Why Choose this Version?

If the methods that you want to validate, verify or transfer are for relatively large molecules (typically > ~2000 Daltons), most commonly biological or biotechnology derived products, also known as biopharmaceuticals or biotherapeutics, then this is the right version for you. It may also be applicable to methods used for advanced therapy medicinal products (ATMPs).

Includes treatment of a variety of analytical techniques typically used for these types of molecules:

- Bioassays - this course will cover common sources of error in bioassays and thus provide an understanding of typical acceptance criteria. It will also provide general guidance on validation of these types of methods. However, the very detailed and complex statistics often used in these types of methods is beyond the scope of the course.
- Binding assays, e.g. ELISA
- Chromatography techniques, e.g., RP-HPLC, Size exclusion HPLC (SEC or GFC), ion exchange HPLC (IEX), HILIC, Affinity chromatography, Hydrophobic Interaction Chromatography (HIC).
- Electrophoresis techniques, e.g., Capillary electrophoresis, gel electrophoresis, Isoelectric focusing.
- Polymerase Chain Reaction (PCR)
- Flow cytometry, e.g., FACS

The video below provides an overview of some of the problems associated with validation of test methods for biopharmaceuticals.

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Course option 2: Biopharmaceutical Analysis 
(Suitable for large molecules)