TRAINING COURSE
How to Develop HPLC Methods for Biopharmaceuticals
This course will enable you to understand how the different types of HPLC used for the analysis of biopharmaceuticals work, and how to develop a new HPLC method, with consideration of the principles outlined in ICH Q14.
Synopsis
HPLC is an important tool in the analysis of biopharmaceuticals, and a range of different types of HPLC are commonly used in quality control laboratories, such as reversed phase (RP), size exclusion (SEC), ion exchange (IEC) and hydrophilic interaction chromatography (HILIC).
On this course you will learn how to select appropriate method conditions and perform suitable investigative experiments for these types of HPLC, following a straightforward 5 step strategy. This will result in a set of method parameters which enables the desired separation for mixtures of analytes.
You will learn how these different types of HPLC methods work and gain an understanding of the factors which can be adjusted to manipulate the retention time of analytes. This will also be very useful for troubleshooting, if required, even if you never need to develop a new method.
Attendees are invited to bring along any real life examples that they would like advice on during the training. These may be discussed during group exercises, or, where intellectual property is an issue, privately with the trainer.
Total learning time = 13 hours
Learning Objectives
On completion of this training course you will be able to:
- Define the objectives for the development of a HPLC analytical method.
- Effectively assess all the available relevant information relating to the desired method, e.g., pKa of the analyte.
- Select and prepare a suitable sample or samples to be used for the method development.
- Select and optimise the chromatographic conditions to result in the best possible separation
- Understand the different options available for the analysis of biopharmaceutical samples.
How is this course delivered?
This course is delivered as a 3 day ‘virtual’ live online training event which is delivered over a 6 hour period on day 1 and day 2, and over a shorter 3.25 hour period on day 3, including breaks.
Day 1 and day 2 are typically from 9am to 3pm, and day 3 is from 9am to 12:15pm (but may depend on your time zone).
More about live online training
Total learning time = 13 hours
More about total learning time
The full agenda is provided in the course description.
The course may also be delivered as in-house training, either in the live online format or in a classroom based format at your site. In-house training allows customisation to meet your specific requirements.
Who will deliver this training course?
All training courses are delivered by the MTS consultant, Oona McPolin. Some recordings of MTS webinars are provided below as examples of Oona’s presentation style.
Who should attend this course?
Anyone who has some experience of using HPLC and wants to know more about how HPLC methods work, and specifically how to develop new HPLC methods which are aimed at biopharmaceuticals using a range of different types of HPLC.
For example:
Researchers who need to use HPLC for biopharmaceutical analysis
Development and Quality Control (QC) analytical chemists
Development and Quality Control (QC) managers/ supervisors
When can I attend this course?
- This course is not currently available as an open enrolment course. However, it is available as an in-house option where we can deliver it to your team either via live online training or by visiting your site. Contact us if you are interested in this option.
- In 2026, we are planning to introduce a comprehensive HPLC method development course applied to both pharma and biopharma, which will include considerations for stability indicating methods. More information will be available soon but contact us if you are interested in this training and have any questions or suggestions.
How much does it cost?
Course not currently available in an open enrolment option.
Included in your course fees:
- Comprehensive course hand-outs – The training book is provided as an electronic copy (pdf) for both live online and classroom based options.
- Certificate of Attendance
- Optional post training assessment (accessed in e-MTS, our learning management system) which leads to a Certificate of Training.
- Access to training materials via e-MTS
- Post training support – Attendees can contact the trainer with questions that may occur when they apply their learning to real life situations.
Notes:
- All prices are quoted per person excluding VAT.
- VAT notice for live online training: For UK business cutomers and non-business customers (B2C) from all countries VAT is charged at the UK rate (currently 20%). For EU business customers (B2B), the reverse charge can be applied on receipt of a valid VAT identification number and VAT will not be charged. For business customers outside of the UK and EU, VAT will not be charged.
Cancellations and Substitutions
Once made and accepted by MTS, course bookings are liable for payment. Payment is due at least 14 days prior to the course start date. Cancellations prior to 3 weeks before the course date are subject to an administration charge of 25%. Cancellations received less than 3 weeks before the start of the course will not be refunded, although substitutions may be made at any time.
We reserve the right to change the programme, speakers, date or venue without notice, or to cancel an event. In the unlikely event of cancellation occurring, delegates will be notified as soon as possible and will receive a full refund of fees paid.