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Delivering an end-to-end industrialization roadmap for autologous cell therapy

An end-to-end industrialization roadmap for autologous cell therapies: specificities and challenges, leveraging automation for scalability with the Cocoon® Platform, and building a vein-to-vein network to achieve ‘just-in-time’ delivery of therapies.
Publish Date: 06-Jul-2021

Fast Speed Manufacturing Scale Expansion - From Lab-Scale to Monoplant

In an extensive case study, the critical success factors enabling successful process implementation, fast manufacturing scale expansion, ergonomic and robust design of a new efficient plant asset--applying a monoplant approach for a highly potent product.
Authors: Christian Noti
Publish Date: 25-Jun-2021

Biopredictive Dissolution Methods

This talk highlights biopredictive dissolution methods for evaluating oral drug product bioperformance. Case studies of amorphous solid dispersion (ASD) formulations are presented, highlighting how biopredictive dissolution methods can be used to streamline formulation development and enable right-first-time drug product formulations.
Authors: Deanna Mudie
Publish Date: 24-Jun-2021

How To Deal With A Difficult-To-Micronize Drug Substance

After giving an overview of micronization and common scale-up challenges, this on-demand webinar presents a robust process development strategy that ensures all attributes critical for quality are maintained for even the most difficult APIs.
Publish Date: 24-Jun-2021

Solid Form Screening and its Role in Drug Development

Solid form screening is a critical component of drug development. Identification of a progressible solid form early in development can save significant time and money and Lonza’s Solid Form Services Group is an agile group that can meet these needs.  To learn more, view the on-demand presentation.
Authors: Michael Grass
Publish Date: 09-Jun-2021

Lonza Integrated Offering

To rapidly progress a molecule, it is important to synthesize the drug substance and determine its’ most stable form such that it is compatible with the final drug product formulation. This on-demand presentation focuses on Lonza’s integrated offering—SimpliFiH® Solutions—an integrated FiH drug substance to drug product services platform. 
Authors: David Lyon
Publish Date: 09-Jun-2021

Powder in Capsule: A Way to Accelerate Drug Product Development by Technologies

The Powder in Capsule (PIC) approach by means of micro-dosing provides an alternative pathway for drug development. Micro-dosing provides a quick way to evaluate the drug substance performance and remain cost-conscious to investments in the development of traditional formulated dosage forms. View the on-demand presentation to learn more on how this can help accelerate your proof of concept to the clinic.
Authors: Mark Cappucci
Publish Date: 09-Jun-2021

Technology Selection for Improving the Oral Bioavailability of Poorly Soluble Compounds

A large and increasing fraction of orally administered small molecules in pharma company pipelines have poor oral absorption due to low aqueous solubility or dissolution rate, requiring an enabling technology to achieve desired exposure. Selecting the appropriate technology for your compound requires careful consideration of the compound physicochemical properties, target dose and pharmacokinetic profile, as well as overall market image. This on-demand presentation covers a general overview of some of the most common bioavailability enhancing technologies and selection criteria for poorly soluble compounds.
Authors: Aaron Stewart
Publish Date: 09-Jun-2021

Particle Engineering Through Micronization

Particle engineering is a key step in the development process that occurs at the drug substance-drug product interface.  Micronization is one of the methods used in particle engineering to control the particle size distribution, enhance bioavailability, and improve content uniformity.  Phase appropriate micronization processes and analytical methods can be developed to supply material for pre-clinical studies, clinical trials, and commercialization.  To learn more, view the on-demand presentation.
Authors: Jason Riggs
Publish Date: 09-Jun-2021

Webinar on Key Regulatory Considerations for Cell and Gene Therapy Products 2021

Webinar presentation from Karen Magers, Global Head of Regulatory, Cell & Gene Technologies on the latest and most important regulatory considerations in the pathway to commercialization of cell & gene therapy products
Authors: Karen Magers
Publish Date: 07-Jun-2021