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Introduction to Vial Fogging and Mitigation Strategies

By Lynn Bondar | February 10, 2022 | Comments Off on Introduction to Vial Fogging and Mitigation Strategies

Vial fogging is a phenomenon commonly observed in lyophilized biologic drug products and has been widely reported in the pharmaceutical industry. The appearance of vial fogging presents as a haze…

Evaluation of Alternative Drying Technologies to Vial Lyophilization: The Maturity State

By Lynn Bondar | February 2, 2022 | Comments Off on Evaluation of Alternative Drying Technologies to Vial Lyophilization: The Maturity State

The presentation will discuss the advantages and disadvantages of foam drying, such as improved storage stability of pharmaceutical products at increased temperatures, faster drying cycles, and better preservation of biologic…

Considerations for Bulk Freeze Drying

By Lynn Bondar | November 11, 2021 | Comments Off on Considerations for Bulk Freeze Drying

In the freeze drying world, most of the work and literature published is related to vial freeze drying and does not touch on some of the differences that are only…

Lyophilized Drug Product Case Study: Risk Mitigation of Primary Packaging through Physical and Chemical Testing

By Lynn Bondar | June 4, 2021 | Comments Off on Lyophilized Drug Product Case Study: Risk Mitigation of Primary Packaging through Physical and Chemical Testing

Accelerate your lyophilized drug development by de-risking your primary packaging selection. Physical and chemical properties of a container closure system for parenterals may affect the drug manufacturing process, product quality…

Next Generation Vials for COVID-19 Vaccines and Cell and Gene Therapies

By Lynn Bondar | March 17, 2021 | Comments Off on Next Generation Vials for COVID-19 Vaccines and Cell and Gene Therapies

The emergence of cell and gene therapies and new COVID-19 vaccines brings the promise of treating some of the most challenging diseases. Storage, transport, and delivery of these breakthrough therapies…

Pharmaceutical Development of Antibody Drug Conjugates, Live with Q&A

By Lynn Bondar | January 25, 2021 | Comments Off on Pharmaceutical Development of Antibody Drug Conjugates, Live with Q&A

Antibody drug conjugates (ADCs) are antibodies equipped with a small number of chemotherapeutic molecules with the aid of a linker system.  They have grown in importance because the antibody targets…

Developing a Transferable Lyophilization Protocol Using a Micro Freeze Dryer with Processing Analytical Technology

By Lynn Bondar | August 3, 2020 | Comments Off on Developing a Transferable Lyophilization Protocol Using a Micro Freeze Dryer with Processing Analytical Technology

This webinar will demonstrate how the MicroFD with LyoPAT can be used to both develop an optimized lyophilization protocol and then transfer the protocol to a pilot or production scale…

Assess Product Heterogeneity and Scale-up Risks in Pharmaceutical Freeze Drying via Mathematical Modeling

By Lynn Bondar | October 30, 2019 | Comments Off on Assess Product Heterogeneity and Scale-up Risks in Pharmaceutical Freeze Drying via Mathematical Modeling

Due to the product pre-conditioning in individual vials, freeze-drying process can be difficult to design and often results in batches presenting a significant heterogeneity in the quality of the final…

Freeze Dry Process Monitoring at Laboratory and Full-Scale

By Lynn Bondar | September 4, 2019 | Comments Off on Freeze Dry Process Monitoring at Laboratory and Full-Scale

The purpose of this webinar is to describe the types of in-process data that can be collected and provide examples of their use. In-process data collected at full-scale are valuable…

Small-Scale Freeze Dryer (MicroFD®) for Cycle Development and Optimization

By Lynn Bondar | July 25, 2019 | Comments Off on Small-Scale Freeze Dryer (MicroFD®) for Cycle Development and Optimization

MicroFD® is a small-scale freeze-dryer where very few vials are loaded: it allows tremendous API savings, beside shortening the stages of batch preparation & loading, condenser defrosting, etc.

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