Alphalyse

Alphalyse believes biotech and pharmaceutical companies can make better medicines by using better analytics to fully understand their biologics

[Alphalyse @Alphalyse]

In these broadcasts, leading advanced therapy and vaccine developers present approaches to the CMC challenges.
The focus is analytical methods for characterizing HCPs, residual proteins, viral vector proteins, and other proteins in their complex products.
https://t.co/Z4u6qr8jq2

[Alphalyse @Alphalyse]

"Odense is to proteomics what Nashville is to country music"
Stephen G. Oliver, University of Manchester

This month our scientists attended the Danish Proteomics Society 16th Symposium.
Why Odense? Well, its per capita concentration of proteomics experts is the World's highest!

[Alphalyse @Alphalyse]

Identify and quantify Host Cell Protein

Our fast LC-MS method is based on SWATH technology. Since the method is generic, we can adapt an assay to any biologic and applied to biopharmaceutical processes in a matter of weeks.

Download application note: https://t.co/xdd8LWDrWN

[Alphalyse @Alphalyse]

How does the#COVID19 virus infect humans?

This fantastic animation shows the complete SARS-CoV-2 replication cycle, from infection to new virus particles being released from the cell.

https://t.co/96nYLobkKD

[Alphalyse @Alphalyse]

How do you answer questions about increasingly diverse and complex samples?

Lately, we have been busy setting up a new Waters Acquity HPLC to supplement our MS analysis for

✔️characterizing drug substance variants
✔️ studying accelerated stability and forced degradation

#HPLC

[Alphalyse @Alphalyse]

Custom HCP ELISA antibodies will only be as good as the mock used for immunization.

So how do you know that your mock sufficiently represents the HCPs in harvest & final drug batches?

Our client used LC-MS data in their investigation and their findings were somewhat surprising

[Alphalyse @Alphalyse]

Vaccines based on VLP technology have high complexity and consist of several different proteins.

🎬Watch for data from
✅ intact mass analysis
✅ glycosylation analysis
✅ peptide mapping
✅ disulfide bridge mapping
✅ id & quantification of HCPs

in one characterization package

[Alphalyse @Alphalyse]

Alphalyse has performed the World's first MS-based HCP analysis under GMP conditions for the release test of the Bavarian Nordic A/S Covid-19 booster vaccine candidate for phase 3 clinical trials.

https://t.co/ALbYi0t3FA

[Alphalyse @Alphalyse]

Our CEO Thomas Kofoed was so excited by the arrival of the new ZenoTOF system that he had to unwrap it himself 🤩

The ZenoTOF is our new instrument for characterization, peptide mapping, and intact mass analysis. We’re excited to start discovering all the cool stuff it can do!

[Alphalyse @Alphalyse]

Have you documented your Cell or Gene therapy product's process-related impurities?

→ If not, Mass Spectrometry provides a convenient and proven way to identify and quantify proteins in complex protein products like cell and gene therapies.

Blog post: https://t.co/bYjfF6I2UK

[Alphalyse @Alphalyse]

Trouble measuring Host Cell Proteins?
Consider a mass spectrometry assay

💡Suitable for all expression systems
💡Measures HCPs, viral, and process-related impurities
💡Costs a fraction of a process-specific ELISA
💡Full validation to ICH Q6B

Learn more: https://t.co/HJxvgUVcUt

[Alphalyse @Alphalyse]

An often asked question:

Unfortunately, we found no suitable commercial HCP ELISA. We are pretty familiar with process-specific ELISA.
But what calls in favor of selecting an MS-based assay?

Get advice in this blog post:
https://t.co/SLerYiUWrH

[Alphalyse @Alphalyse]

Would your AAV manufacturing benefit from quantifying proteins from the producer cell line - and its expression vector system, all in one assay?

🧾 Learn more in this case study:
https://t.co/Qu1qYfAc55

[Alphalyse @Alphalyse]

How do you qualify mass-spectrometry-based Host Cell Protein (HCP) analyses?

Among the parameters, we investigate, are:
1) Accuracy
2) Precision
3) Robustness
4) Specificity
5) Dynamic range

📑Request a copy of our standard qualification protocol: https://t.co/ublzJtvl4d

[Alphalyse @Alphalyse]

Bridging to new ELISA antibodies can reveal surprising shifts in the HCP level → Some clients report increases or decreases from 10 to 100 times!

What's going on? 👇
Find out in this 2-minute video.

More info on https://t.co/zBmR7wqhBa

[Alphalyse @Alphalyse]

Are you monitoring process-related impurities in biologics?

Get free access to our latest publication on HCP analysis by LC-MS and ELISA with data from PPQ runs and regulatory license applications.

https://t.co/CKR39hhTc8

#cmc #hostcellprotein #lcms

[Alphalyse @Alphalyse]

Friday, we celebrated Alphalyse's 20th anniversary 🎉🥳
Around 150 guests and employees made this the most fantastic day - Thank you for making it memorable!

#proteinanalysis #anniversarycelebration #ThankYou

[Alphalyse @Alphalyse]

21 & 22 Sep:
BIOTHERAPEUTIC IMPURITY PROFILING
Expert presentation & Discussion forum
on Current & Emerging Methods & Strategies

Featuring:
Martha Stapels, Sanofi
Ejvind Mørtz, Alphalyse
Jared Auclair, Northeastern University
Annu Uppal, USP India
& more

https://t.co/IR94voSAh3

[Alphalyse @Alphalyse]

Is the “needle in the haystack” ruining your mAb product?

In just 30 minutes, you learn why you need an orthogonal method to ELISA to investigate your mAb for potentially problematic HCPs – down to and below 1ppm.

Start here
💻 https://t.co/cS2wT19hOk

[Alphalyse @Alphalyse]

Do you have an efficient tool for HCP clearance?

This article proposes a new way of securing a comprehensive, 4-dimensional digital record of HCP data for potential future requirement by regulatory bodies.

Free download → https://t.co/M1MKGkxgj5