Newsletter | November 30, 2022

11.30.22 -- CDMO Performance

 
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From The Editor
Featured Editorial
Industry Insights
3 Biopharma Contract Manufacturing Trends You Must Know

Review three biopharma contract manufacturing trends that are indicators of exciting industry developments and also reveal areas that are ripe for change.

Formulation Strategies To Shorten Timelines For First-In-Human Studies

It is important to adopt strategies that create simple but stable formulations for your sterile injectable, thereby establishing a solid foundation for the entire life cycle of your product.

Cell And Gene Therapies: A Guide To Single-Use Connections

This article captures learnings about the use of single-use technologies in biopharma manufacturing that can be applied to cell and gene therapies, with a special focus on connection technologies.

Managing Poor Solubility With Cutting-Edge Formulation Approaches

An increasing number of poorly soluble active pharmaceutical ingredients (APIs) are the cornerstone of cutting-edge therapies, necessitating equally complex formulation technologies to maintain or improve solubility and, ultimately, bioavailability.

Making The Medicine Go Down: Specialized Delivery Technologies

While most oral solid formulations are designed to release the drug immediately after swallowing, some products have been developed to provide a “controlled-release” of the drug products.

Challenges For Microbiome-Based Drug Development

The microbes residing in our gastrointestinal tracts, or the “gut microbiome,” are essential contributors to metabolism and may hold the promise of new treatments for a range of therapeutic applications.

Standardization Is Key To Building A Successful Global Business Strategy

Standardized approaches to biomanufacturing can lower costs, improve outcomes, and alter the landscape of the global pharmaceutical market.

Are End-To-End CDMO Partnerships The Solution To Drug Development And Manufacturing Upheaval?

Growing complexity and risks in drug development and supply have implications for outsourcing models. See how to structure and manage CDMO partnerships for a future full of uncertainty and disruption.

Softgel Technologies Overview

Innovative softgel technologies that maximize your market potential: Where ideation and expertise come together.

Faster Determination Of Dynamic Binding Capacity

Learn more about a way to streamline the downstream process using variable pathlength technology to determine the DBC of affinity chromatography resins to produce reliable data more effectively and efficiently.

The Key Enablers Of Late-Phase Biologics Development And Launch

Dr. Claudia Müller answers questions from a webinar about the complex path to a successful product launch, which requires a holistic development strategy driven by a well-defined target product profile.

4 Time-Saving Solutions To Common Early Development Challenges

Explore flexible solutions that enable you to seamlessly guide your molecule through each early development phase with efficiency and speed.

Inclusion Bodies: Mother Nature's Help Or Hindrance?

The pros and cons of soluble and insoluble processes: isolating, solubilizing, and properly refolding, and strategies to improve the performance of IB processes.

Early Development To Clinic: De-Risking A Bioconjugate’s Journey

The journey of a novel bioconjugate into the clinic is complex and uncertain. Explore the particular challenges when moving a bioconjugate candidate from early development into the clinic.

Biologics Drug Product: Formulation, Tech Transfer, Delivery Strategies

Review key considerations for formulation screening of therapeutic proteins and how consistency, planning, and communication are essential for a successful biologic drug product tech transfer.

Manufacturing Innovation Across New Modalities

The successful outcomes delivered by cell and gene therapies, coupled with the emergence of modalities across nucleic acid therapeutics and microbiomes, pose the next scalability challenges.

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Solutions
Outsourced Pharma Live
 

Available On Demand! Throughout the year, chief editor Louis Garguilo brings together industry experts to discuss some of the biggest challenges being faced by both sponsors and CDMOs. Our archived videos can be accessed at any time by registered site users.