eChalk Talks


Co-processed HPMC-mannitol: A Directly Compressible Excipient for Controlled Release

October 4, 2023, 1:15-1:45 pm ET

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During this eChalk Talk we will be delving into controlled-release applications that can be used in direct compression, focusing on two well-known ingredients, hypromellose (HPMC) and mannitol, for the controlled-release application to be used in direct compression.

In the study presented, we compare the differences in the performance of a simple blend of ingredients and the benefits of a co-process, improving flowability and minimizing process variation, allowing the development of controlled release formulations by direct compression instead of wet granulation.
With the usage of the developed co-process, it is possible to simplify the development process, reduce the production costs, such as labor work and fewer steps during the manufacturing, and ease the validation, as fewer variables are presented in the process and the number of ingredients in the formula.

Furthermore, the formulations using Mannitol: HPMC co-processed provide excellently controlled release performance for different APIs BCS class I and III, high solubility, comparable to those made by granulation, keeping the safety regarding dose dumping, as it is alcohol resistant, and the stomach enzymes do not digest it.

Speaker:  Talles Ernica, Roquette

Risk Mitigation in Bioanalysis to Maintain the Integrity of Drug Development Studies

October 11, 2023, 11:15am – 11:45 am ET

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It is critical to prioritize safety in drug development studies. The bioanalysis data plays a vital role in the decisions taken during the development process and it is crucial to ensure that the results obtained are reliable. Therefore, prioritizing risk mitigation in bioanalysis is essential to maintain the integrity of drug development studies.

Ligand binding assays (LBA) are widely used to quantify biopharmaceuticals and biomarkers, as well as to evaluate immunogenicity in preclinical and clinical studies. In this presentation, we will highlight key factors to keep in mind when developing a ligand binding assay. The focus will be on creating a robust assay with high specificity and selectivity. We will show real-life common challenges through case studies and suggest solutions based on our extensive experience in developing ligand binding assays.

Speaker: Tanja Jarhede, Ph.D., Mercodia

Bioanalytical Strategy for PK Assessments of ATMPs

October 18, 2023, 1:15-1:45 pm ET

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The emergence of advanced therapeutic medicinal products (ATMPs), such as cell and gene therapies, has led to the increased utilization of specialized technology platforms in regulated bioanalysis. In this eChalk Talk, we will discuss platforms that are used in determining pharmacokinetics (PK) of ATMPs including qPCR, and flow cytometry. We will also highlight some of the key considerations for development and validation of these types of PK assays to support ATMP drug development.

Speaker: Amanda Hays, Ph.D., BioAgilytix

What Stands Out With the M10 Guidance?

November 1, 2023, 11:15 – 11:45 am ET

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The culmination of work to integrate the international guidelines on bioanalytical method validation and sample analysis into one standard document was reached on June 2022 with the ICH publication of the M10 Guidance of ‘Bioanalytical Method Validation and Study Sample Analysis’ (M10). The European Medical Association (EMA) adopted the guidance in July of 2022 with an effective date of January 21, 2023, followed by the issuance of the guidance on November 4, 2022, by the US Food and Drug Administration (FDA). Unlike the 2018 US FDA bioanalytical method validation guidance, the M10 guidance does not apply to biomarkers. There were several aspects of the M10 that varied significantly from both the 2012 EMA and 2018 FDA bioanalytical guidances on method validation, such as the approaches to determining matrix effects and the requirement to conduct whole blood stability and lipemic assessment with human clinical sample, as well as the approach to conducting selectivity studies, precision and accuracy experiments and defining the acceptance ranges of the different levels of QCs. Most notably are the changes in reporting requirements. This webinar will discuss the various aspects of the ICH M10 guidance and highlight the differences between the M10 guidance and the previous bioanalytical method validation and sample analysis guidances.  

Unlock the Potential of Hydroxypropyl Beta-cyclodextrin in Biologics Downstream Process and Formulation Development

November 8, 2023, 1:15-1:45 pm ET

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Ensuring product stability is of utmost importance in both downstream processing and formulation of biopharmaceuticals, encompassing monoclonal antibodies (mAbs) and recombinant proteins. The challenges posed by stresses such as shear stress and elevated temperatures during unit operations like column chromatography, filtration (including ultrafiltration/diafiltration and nanofiltration), as well as during shipment and storage, have the potential to induce protein aggregation and precipitation. This jeopardizes the drug's safety and efficacy. Thoughtfully selecting appropriate excipients can substantially alleviate the instability concerns associated with biologics throughout the downstream process, as well as during storage and transportation.

In this presentation, we will showcase case studies demonstrating how HPBCD (hydroxypropyl beta-cyclodextrin), a recognized excipient in numerous approved parenteral formulations, can enhance protein stability and mitigate the formation of visible/sub-visible particles during ultrafiltration/diafiltration (UF/DF) and accelerated stability studies of monoclonal antibodies.

Speaker: Ketaki Patwardham, Ph.D., Roquette