Newsletter | January 13, 2021

01.13.21 -- Do Your CDMO And Consultants Get Along? They Better

From The Editor
Featured Editorial
Industry Insights
Strategies For API Solubility And Bioavailability Enhancement: Selecting Technologies And Excipients

Bypassing conventional trial-and-error methods for solubility challenges and excipient selection can eliminate unnecessary testing, improve the efficacy of formulations, and increase overall speed-to-market.

Intelligent And Streamlined Drug Product Manufacturing: Ensure Scalability, Overcome Regulatory Hurdles, And Speed Time-To-Clinic

The speed and quantity at which novel vaccines, therapeutics, and candidates are currently entering into clinical development is unparalleled. Capacity for manufacturing these products is in high demand. Due to this ever-changing landscape, it is more important than ever to partner with a CDMO that is proactive with how they plan, resource, and execute programs.

Small Molecule Impurities: A Control System Design Challenge For ADCs
Composed of both antibody and small molecule elements, antibody-drug conjugates (ADCs) have a complex structure from which many different impurities can arise.
The Biotech And The CDMO: The Case For An Early Partnership

Biotech investigators can’t possibly know everything required to move their drug candidate from the lab bench to the marketplace. Accepting that reality is the first step toward finding a strategic partner whose broad knowledge base and experience complements your specialized expertise. Whom you partner with, and when, can make all the difference down the road.

Softgel Technologies Overview

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

Customer Loyalty In Small Molecule Drug Product Manufacturing

ISR surveyed 136 sponsors who outsource drug product manufacturing for small molecule compounds to gain insight into their overall satisfaction, willingness to recommend, and likelihood to use the CMO again.

Process Characterization: Ready For The FDA?

Greg Sears, Ph.D., global director, process characterization, head of manufacturing science and tech, pharma services, biologics at Thermo Fisher Scientific, discusses process characterization basics.

OP-Virtual On-Demand
What COVID-19 Vaccines Teach Us About All Tech Transfers

Are there lessons learned and best practices from the COVID-19 vaccine efforts you can apply to tech transfers of your own projects — be they small molecule, biologics, or cell and gene therapies? View the on-demand version of OP-Virtual from our discussion on November 4, 2020, on what we’ve learned thus far and how to transfer that knowledge to your projects.