30 min webinar Learnings from 150+ projects

Moving LC-MS analysis into a GMP environment

Across the industry, it has been a challenge to achieve Host Cell Protein analysis by LC-MS that complies with GMP due to the complexity of the sample preparation and data analysis, the sophistication of high-end mass spectrometers, and the lack of reproducibility of the complete workflow.

Join our 30-minute webinar and find out:

How robust and reproducible is impurity profiling by mass spectrometry?
Is it possible to transfer the method to a GMP environment?
Which parameters should be tracked in the process?

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YES - Show me how you qualify MS data >>>

You probably already know that…

… for new biologics under development, validated HCP impurity assays are required for the GMP release test to show product purity.

However,

Generic HCP-ELISAs often do not have sufficient coverage of the manufacturing process, and therefore, you would develop a process-specific ELISA.

But in some cases, this is not possible – e.g., for complex gene therapies consisting of proteins from several organisms.

Instead, many companies use Mass Spectrometry (MS) as an orthogonal method to ELISA

– especially since MS can identify and even quantify impurities at an individual level.

But is mass spectrometry available under GMP?

At this point, no one has established a robust LC-MS method for Host Cell Protein characterization that complies with GMP. It has been challenging due to

the complex sample preparation and data processing,
the sophisticated high-end mass spectrometers,
and the lack of reproducibility of the complete workflow.

So, how does Alphalyse address the challenges with variability?

Alphalyse scientists developed a robust and automated workflow based on data-independent and data-dependent mass spectrometry, along with intact proteins as internal standards for quantification and workflow optimization.

For the past three years, we have investigated the robustness and reproducibility of the method in more than 150 projects.

The projects include different expression systems (e.g., CHO, E. coli, HEK, adenovirus), types of biologic (e.g., mAbs, recombinant proteins, vaccines, and gene & cell therapy products), and complexity of samples (e.g., from early process samples to final purified drug substances).

Common for all projects is that we used the same set of 7 standard proteins as internal standards. Therefore, we can now evaluate different parameters of importance for method validation and transfer the method to a GMP environment.

In this 30 minute webinar with Thomas Kofoed, Co-founder of Alphalyse, you will get:

An overview of the parameters that influence the reproducibility of mass spectrometry data
Insights on how we have optimized the technology to manage and track variability
A study of the reproducibility of mass spectrometry data across projects and time, for use in GMP validation
Example of a client method qualification, included in their IND, which FDA approved recently

Show me the reproducibility of MS data >>>

More than 150 client projects using LC-MS data

Talks at the world’s most recognized Host Cell Protein conference, BEBPA, featuring data in 2017, 2018, 2019, 2020, and 2021.

With Alphalyse results, we intelligently removed the HCPs and shortened the process by at least one year compared to previous projects

Senior Manager, Process Development

Clinical-stage biotech company

Examples of companies who used our services:

Attend this webinar if:

You manage a biologic’s development and want to minimize risk, cost, and development time.
You are a technical specialist and struggle with inconsistent commercial HCP-ELISA kits.
You wish to quickly reduce the overall level and remove specific HCPs in few efficient purification steps.
You work with an uncommon expression organism that does not yet have a suitable ELISA.

Or want to brush up on the newest technologies for Host Cell Protein analysis and how to achieve a GMP compliant LC-MS method.

Our experienced experts:

Our lab is probably the most experienced in the world for HCP profiling of biologics by Mass Spectrometry:

We spent more than five years developing and optimizing the Alphalyse analysis.
We apply the method to all types of process samples and all expression systems, including CHO, E. coli, yeast, etc.
Our team conducted 150+ projects in the last three years and is well underway to offer the service under GMP.

– About the webinar –

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SURE - It’s worth 30 min of my time >>>