Speakers: Tony Edge, Ph.D., Site Director (Product R&D), Avantor Hichrom
Tony Edge
 
When: Wed, Nov 3, 2021 9:00 AM - 10:00 AM PDT
 
Event Overview: In the summer of 2018, the pharmaceutical landscape for the manufacture of small molecules has changed forever with the discovery of a genotoxic compound called N-nitrosodimethylamine (NDMA) in a batch of Valsartan manufactured by Zhejiang Huahai Pharmaceutical in China. Valsartan is a prescription only drug to treat high blood pressure and heart failure, which is a selective angiotensin II receptor blocker (ARB) used to dilates blood vessels. In routine analysis, the QC chemists found that there were approaching 60 ppm of NDMA, which is high enough to cause one extra case of cancer in 500 patients. On 5th July of 2018, the European Medical Agency (EMA) gave notice to recall selected batches of Valsartan with immediate effect. Since 2018, NDMA and other nitrosamines have been detected at alerted levels in a range of different pharmaceuticals.
 
This webinar will look at the chronological development of the story and how nitrosamines have caused the pharmaceutical industry to re-evaluate their manufacturing procedures. It will look at the synthetic pathways that can generate these genotoxins and the regulatory landscape that has evolved as a consequence of the initial findings. We will then discuss the development of a series of applications that will allow for the determination of nitrosamines that have been identified as genotoxins by the US Food and Drug Administration (FDA) to monitor, initially showing how to perform a separation of these compounds from the active pharmaceutical ingredient (API) and then looking at how mass spectrometry can be applied to the analysis to ensure that the required detection limits can be reached.
 
Key learning Objectives:
• Learn the importance of testing for NDMA concentrations in pharmaceuticals
• Understand the regulatory landscape that has evolved to deal with this range of genotoxins such as nitrosamines impurities
• Review examples of nitrosamine analysis
 

Speaker: Stephanie A. Schuster, Senior Technical Support Scientist, Advanced Materials Technology, Inc.
 
Stephanie
 
 
When: Wed, Sep 22, 2021 9:00 AM - 10:00 AM PDT
 
About the Speaker: Dr. Schuster earned her B.A. at La Salle University, and her Ph.D. under the guidance of Prof. Joe P. Foley at Drexel University. After graduation, Stephanie spent nine months at Atlantic Diagnostic Laboratories, a combined clinical and forensic testing laboratory. She joined Advanced Materials Technology, Inc. (AMT) located in Wilmington, DE in June 2009 as a research scientist working with Dr. Jack Kirkland, providing contributions to the commercial development of products designed specifically for the separation of peptides and proteins. Most recently, as part of the Technical Support team at AMT, Stephanie has been providing customers support in optimizing and trouble-shooting their applications. Stephanie has several peer-reviewed articles and is a member of the Chromatography Forum of the Delaware Valley (CFDV) and the American Society of Mass Spectrometry (ASMS).
 
Abstract: Monoclonal antibodies (mAbs) continue to be among the top selling pharmaceuticals because they are such effective therapeutics. Not only are mAbs used for disease treatment, but they are also used for research and diagnostic purposes. Characterization of mAbs is a critical step in their development. Intact analysis may be completed by LC-UV or LC-MS methods using Fused-Core particle columns. Additionally, post-translational modifications (PTMs) of mAbs must be characterized and controlled. Many PTMs are polar by their nature, including glycosylation, deamidation, and oxidation. These types of polar modifications lend themselves to analysis via hydrophilic interaction liquid chromatography (HILIC) since they can be better resolved than with reversed-phase chromatography. Examples of glycosylation, deamidation, and oxidation of different mAbs will be demonstrated using LCMS under HILIC conditions.
 

 Speaker: Yichen Wang, Specialist of Ion Chromatography, Product Manager of SHINE Ion Chromatography
Yichen Wang
 
 
When: Wed, Aug 25, 2021 9:00 AM - 10:00 AM PDT
 
Abstract: Ion chromatography (IC), a well-established form of liquid chromatography, uses ion-exchange resins to separate cations or anions. There are two types of IC, anion-exchange and cation-exchange. Equipped with different detectors, IC could be a powerful separation technique to address challenging analytical tasks. For example, IC can detect carbohydrate in dairy products using electrochemical detector. Recently, IC has been extensively used for purification and characterization of biopharmaceutical drugs such as monoclonal antibody (mAb) and adeno-associated virus (AAV). Trace analysis of elemental impurities with low detection limit can be achieved with combination of ICP-MS/MS. It is possible to detect hexavalent ions such as chromium at ppt levels in toys.
 
Due to its excellent sensitivity, selectivity, and fast speed, IC has proven to be a very useful technique for determination of both organic and inorganic ions (in particular non-metal ions) and applied in various fields such as food, environmental, material and pharmaceutical analyses. To explore the growing interest of IC in pharmaceutical industry, this seminar will start with a brief introduction of IC principle, operation, and instrumentation followed by its application in analysis of raw materials, intermediates, drug substance, excipients, and finished drug products based on pharmacopeia standards from different countries.
 
Key Learning Objectives:
• Brief introduction of IC Principle, operation and instrumentation
• Application of IC in pharmaceutical drug analysis
 
Who Should Attend:
• IC users and method developers in pharmaceutical, chemical, clinical, environmental, agrichemical, contract research organizations, universities, and governmental laboratories.
 

Speaker: Chris Pohl, Vice President, Research & Development, Chromatography Chemistry, Thermo Fisher Scientific

Chris Pohl

 

When: Wed, Aug 4, 2021 9:00 AM - 10:00 AM PDT

Registration link: https://register.gotowebinar.com/register/7467419398288012048

Abstract: Since the approval of the first therapeutic monoclonal antibody, muromonab-CD3, in 1986, the field of monoclonal antibody therapeutics has exploded into a variety of monoclonal antibody-based therapeutics, such as bi-specifics and antibody drug conjugates (ADCs). Unlike small molecule drugs whose production can be tightly controlled, production of biotherapeutics using biological vehicles creates its own challenges in not only producing a pure product but also a properly conformed one. The need to characterize product quality attributes continues to be of critical importance in ensuring the efficacy and safety of biotherapeutics. Since Dionex released the ProPac WCX-10 in 1998 for charge variant analysis, the team in Sunnyvale, led by Chris Pohl (VP R&D), has continued to develop new generations of columns focused on large molecule chromatography, based on feedback from the Biopharma community to address regulatory approval requirements. Charge variants, oxidation, deamidation, and drug to antibody ratios are just a few of the analysis that have become commonplace, and Thermo Fisher Scientific has led the way in offering chromatography solutions for biotherapeutics characterization, from ProPac WCX-10 to ProPac ELITE and CX-1 buffers. Join us to learn what we’ve learned from the biopharma community during the past 23 years.

 

Key Learning Objectives: • HPLC based techniques for characterization of monoclonal antibody-based biotherapeutics

Who Should Attend: • Method developers for UHPLC and HPLC methods supporting monoclonal antibody development • Method QC chemists who use these columns (ProPac WCX-10, ProPac ELITE, etc.) everyday

Speakers:

• Dr. Shengsheng Xu, Senior Scientist II, Bioanalytical Services, Frontage Laboratories, Inc.

• Dr. Ke Li, Senior Scientist I, Bioanalytical Services, Frontage Laboratories, Inc.

 

Keli

Registration link: https://register.gotowebinar.com/register/8388674901497093647

Date: June 30, 2021, Wed., 12:00 PM EDT

Abstract: Protein therapeutics have become more and more popular in recent years due to their high target specificity and relative low toxicity. The structural complexity of these biologics poses challenges to gold standard bioanalytical approach, as known as ligand bind assay (LBA), which is unable to detect any structural alterations happen on proteins. These potential structural changes on protein therapeutics are critical for pharmacokinetic (PK)/pharmacodynamics (PD) evaluation. On the other hand, protein biomarkers have entered into a new phase for drug discovery. The association between target protein biomarker and other endogenous proteins raises the concern for applying LBA based assay. LC-MS has emerged as a state-of-the-art technique to overcome this type of challenges in quantitation of protein therapeutics and protein biomarkers. This webinar will review the application of different LC-MS based approaches including bottom-up, top-down and middle-down. Case studies relevant to these approaches will also be presented.

 

Key Learning Objective:

• Bioanalytical Challenges & Approaches for protein therapeutics and biomarkers Who Should Attend:

• Bioanalytical method developers for protein therapeutics and biomarkers

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