Lonza Pharma & Biotech

This webcast will explore the benchmark practices for rapid progression from first-in-human to large-scale commercial manufacture for microdosing API. Xcelodose-based systems are an industry standard for rapid and accurate microdosing and an integral part of accelerated pathways to first-in-human studies. Utilization of the Xcelodose technology can increase speed to clinic and quickly assess new compounds while remaining cost-conscious. Upon successful clinical studies, scale up to large-scale manufacture has previously been a limitation. When micro-dosing with the innovative Harro Höfliger Modu-C Mid Speed Encapsulator, these limitations are no longer an impediment to scale-up and commercialization.

Xcelodose utilization for first-in-human studies

Rapid transfer from first-in-human to commercial manufacturing

Scale up to commercial production using the Harro Höfliger Modu-C MS Encapsulator

Anyone in the Oral Solid Dosage Manufacturing Industry

Webcasts

Thursday, August 26, 2021 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST

This webcast will explore the benchmark practices for rapid progression from first-in-human to large-scale commercial manufacture for microdosing API. Micro-dosing at a commercial scale made effortless.

First-in-Human to Commercial: A Microdosing Journey

Amorphous solid dispersions (ASDs) are an important technology for improving oral absorption of poorly water-soluble drugs. To achieve robust ASD drug products, pharmaceutical scientists must design ASD formulations to attain several key attributes including 

 performance, stability, and manufacturability while minimizing dosage form size. Combining knowledge of key drug, polymer, and gastrointestinal properties together with an 

 toolkit is critical for achieving key attributes while reducing development timelines and drug substance requirements.

This webinar highlights best practices for streamlined development of ASD drug products using traditional and novel formulation architectures.

 tools can be combined to streamline ASD formulation development

Gain knowledge about how drug and polymer properties, drug loading and dosage form architecture can influence ASD 

Learn how to maximize drug loading in ASD dosage forms while still achieving good performance, stability, and manufacturability

: Deanna Mudie, Ph.D, Principal Scientist, Lonza

Aaron Stewart, Associate Principal Scientist, Lonza

: Thursday, January 28, 2021 at 11am EST | 8am PST | 4pm GMT | 5pm CET

On demand available after final airing until Jan. 28, 2022

***Live: Thursday, January 28, 2021 at 11am EST | 8am PST | 4pm GMT | 5pm CET*** Amorphous solid dispersions (ASDs) are a critical technology for bioavailability enhancement. In this webcast Lonza’s Deanna Mudie and Aaron Stewart discuss Lonza’s best practices for ASD formulation development and in vitro testing.*** On demand available after final airing until Jan. 28, 2022.***


Enabling Streamlined Formulation Development of Amorphous Solid Dispersion Drug Products

http://promo.mjhlifesciences.com/biopharmacongress/

The COVID-19 pandemic has disrupted the routine of in-person events, the need for sharing information and building key supplier connections for bio/pharmaceutical development and manufacturing has never been greater.

The 2020 Bio/Pharma Virtual Congress event will connect bio/pharma formulation, development, manufacturing, and quality experts with a full day of technical presentations, panel discussions, interviews, and vendor meetings, through an interactive portal.

This online event will explore the latest developments in formulation, manufacturing, and innovative drug dosage forms, as well as detailed discussions about crucial topics impacting the industry.

Adare, Aizon, BASF, Beckman Coulter, Catalent, DocuSign, Honeywell, Lighthouse, Lonza Pharma and Biotech, LSNE, Mikart, Nelson Labs, Qualicaps, Shimadzu, suez and VAI

Wednesday, November 11, 2020 | 8:30 AM EDT – 4:00 PM EDT

On demand available after airing until Nov. 11, 2021.

*** Live: Wednesday, November 11, 2020 | 8:30 AM EDT – 4:00 PM EDT *** 2020 Bio/Pharma Virtual Congress: Join Pharmaceutical Technology® and BioPharm International® for this online event that will explore the latest developments in formulation, manufacturing, and innovative drug dosage forms, as well as detailed discussions about crucial topics impacting the industry. ***On demand available after final airing until 11/11/2021

2020 Bio/Pharma Virtual Congress

Articles

Learn more about speed-to-market, a critical aspect of developing new pharmaceutical products, and the significant interest on the science of scale for spray drying.


Science of Scale for Spray-Dried Intermediates

https://www.pharmtech.com/pt_w/visual_techniques

Lipid multiparticulates (LMPs) are versatile drug delivery systems that offer flexibility in both drug release and final dosage form. The wide variety of available matrices and formulation approaches make LMPs amenable to a broad range of targeted release kinetics and delivery strategies. The solvent-free melt-spray-congeal process results in LMPs with controlled and narrow particle size distributions. For the final dosage form, LMPs can be given as sachets, incorporated into capsules and tablets, or used as injectables.

This webinar discusses the process for formulation selection and LMP manufacturing through the lens of visual techniques to study critical-to-quality attributes.

Thermal light microscopy is used to identify API–lipid miscibility and resultant particle architectures giving insights into API solubility as a function of temperature, impacts of API on lipid congealing temperature and subsequent manufacturability, and stability. High-speed imaging of the atomization process evaluates the impacts that critical process parameters and melt formulation properties have on the melt film flow, atomization dynamics, and resultant particle size.

This webcast will descrive how using these techniques in conjunction with predictive models can result in a streamlined progression for LMP

Understand what LMPs are and how formulation and dosage form make them a flexible pharmaceutical drug delivery option.

Learn how thermal microscopy can be a tool to aid in formulation selection.

Demonstrate how variables of the manufacturing and atomization process are used to control product quality.

Cody Prather, Engineer III, Research & Development, Lonza Pharma & Biotech

Amanda Pluntze, Scientist II, Research & Development, Lonza Pharma & Biotech

: Friday, November 20, 2020 at 11am EST | 8am PST | 4pm GMT | 5pm CET

On demand available after final airing until Nov. 20, 2021

***Live: Friday, November 20, 2020 at 11am EST| 8am PST| 4pm GMT| 5pm CET*** Lipid multiarticulate (LMPs) are versatile drug delivery systems which offer flexibility in both drug release and final dosage form. This webinar discusses the process for formulation selection and LMP manufacturing through the lens of visual techniques.*** On demand available after final airing until Nov. 20, 2021.***


Applying Visual Techniques to the Product Design of Lipid Multiparticulates

Executive summary presents clinical services and integrated first-in-human solutions for effective accelerated timelines support. Case studies demonstrates best practices in complex packaging and DtP supply.