Newsletter | July 19, 2021

07.19.21 -- Genesis Of A Gene Therapy Manufacturing Giant

Featured Editorial
Industry Insights
Lipid-Based Formulations: Accelerate Development, Shorten Timelines

Lipid-based formulation technology advancements and formulation guidance tools can shorten timelines and increase the success rate in reaching the target product profile in early development.

Complex Molecule Development: Early Considerations To Avoid Failure

How to understand and prepare for challenges early in development to avoid bottlenecks that significantly slow production and delay a drug’s time-to-market.

What Are Exosomes?

Gain an understanding of exosomes, which are recently attracting attention as new mediators of cell-to-cell communication, transporting biomolecules such as lipids, proteins, and RNAs in vivo.

Innovation And Flexibility During The COVID-19 Pandemic

How one CDMO embraces the discovery of new COVID-19 diagnostics, treatments, and vaccines as they collaborate with customers to develop and manufacture new molecules.

The Case For Repatriating The Pharmaceutical Supply Chain
The pandemic has broadcast a loud call to bring our pharmaceutical supply chain back to the U.S. to provide greater regulatory control and patient, economic, and workforce benefits.
How Oral Solid Coating Technologies Can Enhance Delivery Strategy

Oral solid dose (OSD) remains a dominant form in drug delivery and development. Discover advances that improve oral solid stability and integrity through technology platforms and coating technologies.

Are You Prepared To Move Bioconjugates From Clinic To Market?

Despite the potential of antibody-drug conjugates (ADCs) and other bioconjugates, they present a wide range of challenges for drug manufacturers trying to navigate their way to commercial success.

Single-Vendor CDMOs Bring Speed And Cost Savings To The Table

As drug developers face the ever pressing need to get molecules to market as efficiently as possible, firms large and small are increasingly turning to CDMOs for help.

Scaling-Up Pluripotent Stem Cell Production: Begin With The End In Mind

Pluripotent stem cells (PSCs) have the potential to generate any cell type in the body and can be considered the raw or input material for cell replacement therapies. 

Defying The Shortages In Single-Use Manifold Assemblies

A shortage of single-use supplies can cripple a production line. Manufacturers need to pick up the pace, as single-use supplies are scarce or being stockpiled in the era of COVID-19 vaccine production.

Filling Complex Parenterals In Powder, Liquid, Suspension Form

Traditional filling lines lack the necessary versatility to address the growing number of complex and personalized parenteral drug products that are now being brought to market. 

Explore Protein Function Using Surface Plasmon Resonance

How an academic research group used the Biacore™ X100 SPR system in their research to investigate protein-RNA and protein-protein interactions and used surface plasmon resonance (SPR) to measure antibody specificity.

Bridging Anti-CHO HCP Antibodies From Two Third-Gen CHO HCP ELISA Kits

This study is an antibody coverage comparison of polyclonal antibodies supporting the original Chinese hamster ovary (CHO) host cell protein (HCP) ELISA Kit, 3G, F550 vs. the resupply CHO HCP ELISA Kit, 3G, F550-1.

Developing A Closed, Connected Single-Use Monoclonal Antibody (mAb) Purification Process

This article provides an overview of a successfully designed closed and physically connected monoclonal antibody (mAb) process at the pilot scale with single-use components.

The Effect Of Mixing On Protein Using Mobius® Mixers

Mixing equipment may have to be used without distinction for all applications. This application note explores the suitability of the different Mobius mixer types for various model feeds.

Support Manufacturing Operations With Process Data Management Software

Learn how process data management software automated data acquisition for clinical-stage allogeneic CAR T and in vivo gene therapy developer Precision BioSciences (NASDAQ: DTIL).

Understanding Outsourced Service Roles And Responsibilities

Learn directly from real decision-makers and influencers to create and/or refine personas in a way that effectively represents the buying universe.

Are You Protecting Your Employees During HPAPI Manufacturing?

As biomanufacturers venture into the rapidly growing market of highly potent active pharmaceutical ingredients (HPAPIs), it is important to consider whether they have the resources and capabilities to protect their product and their employees.

Product Characterization: Reveal Your Molecule Earlier, Faster, More Accurately

Choosing a partner to support your product characterization needs can streamline your drug development program and create efficiencies in moving from concept to clinic. 

Experimental Design, Statistical Tools For Package Integrity Testing Systems

This short podcast focuses on experimental design and statistical tools we use with nondestructive package integrity test systems. 

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