| 00:00:00 | Welcome |
| 00:00:11 | A comprehensive guide for technologies to assess particle content in injectable drugs |
| 00:00:15 | Introduction |
| 00:01:03 | Abstract |
| 00:01:51 | What do you mean by ‘particles’? |
| 00:03:01 | What do you mean by ‘particles’? |
| 00:03:25 | What do you mean particles? |
| 00:03:55 | What do I need to measure? |
| 00:06:24 | What has the FDA said? |
| 00:07:38 | So what can I use to measure my particles? |
| 00:09:32 | So what can I use to measure my particles? |
| 00:09:58 | Light Obscuration |
| 00:11:15 | Flow Image Analysis |
| 00:12:41 | Malvern Technologies for Subvisible Particles |
| 00:13:46 | Malvern technologies for subvisible particles |
| 00:15:46 | Malvern technologies for subvisible particles |
| 00:17:22 | Archimedes – an exclusive technology to count and separate subvisible particles based on their density |
| 00:18:43 | Archimedes application example |
| 00:19:31 | Archimedes - Distinguishing protein from silicone oil |
| 00:21:27 | Identification of Subvisible Particles |
| 00:22:54 | Morphologi G3SE-ID |
| 00:24:44 | Identification of Subvisible Particles in Suspended Bioformulations |
| 00:26:48 | Identification of Subvisible Particles in Suspended Bioformulations |
| 00:26:53 | Application example |
| 00:27:57 | Counting & identification of particles captured on filter membranes |
| 00:30:39 | Identification of Particles Whislt in Solution |
| 00:32:33 | Submicron Particle Charaterization |
| 00:33:58 | NanoSight – submicron particle characterization |
| 00:34:03 | Protein aggregation |
| 00:35:14 | Concentration – protein aggregation |
| 00:36:11 | Heat-induced protein aggregation: |
| 00:37:03 | Why should I use all of these techniques? |
| 00:37:59 | Why should I use all these techniques? |
| 00:38:38 | Why should I use all these techniques? |
| 00:39:39 | Thank you for your attentionAny questions? |
| 00:41:44 | Contact Information |
In recent years, the delivery of biological drugs via prefilled syringe-style devices has rapidly become more prevalent, in direct response to consumer demand. However, there are some challenges associated with this delivery method. One such challenge is understanding and characterizing the formation of particulates in the subvisible and submicron range within the final drug product.
These particulates can result from manufacturing and fill issues, exposure of the product to temperature or mechanical stress, or reaction of the drug to excipients and contaminants, as a few examples. Since silicone oil is widely-used as a lubricant for syringe plungers and for coating the barrels of syringes, it is commonly found in droplet form as a contaminant in injectable formulations.
In some cases, it is thought that silicone oil droplets may act as a nucleus to promote the formation of protein aggregates in drug products, potentially increasing unwanted immunogenicity.
This presentation provides a comprehensive review of current and recently-developed technologies which can be used for the assessment of particular content in therapeutic formulations.
These particulates can result from manufacturing and fill issues, exposure of the product to temperature or mechanical stress, or reaction of the drug to excipients and contaminants, as a few examples. Since silicone oil is widely-used as a lubricant for syringe plungers and for coating the barrels of syringes, it is commonly found in droplet form as a contaminant in injectable formulations.
In some cases, it is thought that silicone oil droplets may act as a nucleus to promote the formation of protein aggregates in drug products, potentially increasing unwanted immunogenicity.
This presentation provides a comprehensive review of current and recently-developed technologies which can be used for the assessment of particular content in therapeutic formulations.