Watch all of the great on-demand content from our symposium, co-hosted by Biocom California

 

 

This symposium brings forth industry experts, who discuss how a significant fraction of the biopharma pipeline is held by small – and even virtual – biopharma companies. These companies often lack all of the capabilities, expertise and/or bandwidth necessary to advance their molecules to initial clinical studies. In the absence of internal resources, small biopharma often look to contract development and manufacturing organizations (CDMOs) to support their development programs. While it is common to support these activities through consultants and multiple CDMOs, studies indicate that working with a single integrated service provider for API and drug product can reduce complexity, development timelines, and costs.


The Importance of CDMOs in the Drug Development Process – Based on Experience Running a CDMO and a Biopharma

Tim Scott, CEO, TEGA Therapeutics

This is a discussion about quality and outsourcing.  Relative to other industries, the pharma sector is still learning how to outsource.  Developing quality products is not a marketing goal, it is a regulatory goal.  Quality comes at the cost of time and resources.  In this on-demand presentation, both theoretical and practical aspects of quality are discussed, as they pertain to contract development and manufacturing. 

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Lonza Integrated Offering

David Lyon, PhD, Senior Fellow, Global R&D

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.

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Solid Form Screening and its Role in Drug Development

Michael Grass, PhD, Head of Solid Form Services

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.

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Powder in Capsule: A Way to Accelerate Drug Product Development by Use of Micro-dosing Technologies

Mark Cappucci, Preformulation Team Lead

The Powder in Capsule (PIC) approach by means of micro-dosing provides an alternative pathway for drug development. Micro-dosing is the precision weighing of drug substance, blends or other formulations directly into the capsule. The benefits of PIC help streamline product development and increase the speed to clinic and proof of concept. It helps provide a quick way to assess the drug substance behavior and remain cost-conscious to investments in the development of traditional formulated dosage forms. View the on-demand presentation to learn more.

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Particle Engineering Through Micronization

Jason Riggs, PhD, Senior Process Development Scientist

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.

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Technology Selection for Improving the Oral Bioavailability of Poorly Soluble Compounds

Aaron Stewart, MS, Associate Principal Scientist

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.

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