Newsletter | February 22, 2021

02.22.21 -- Certifying Pharmaceutical Exports: An Introduction To FDA's Certificate Of Pharmaceutical Product

Featured Editorial
Industry Insights
High-Loaded Dosage Forms: Novel Platform Expands Dispersion Utility

Spray-dried amorphous solid dispersions (ASDs) show enormous promise in the delivery of drug compounds with low solubility. A novel platform expands the utility of this approach to meet patient needs.

High-Throughput And Single-Use mAb Purification With Fibro Chromatography

How rapid cycling, fiber-based chromatography (Fibro) enables substantially reduced purification times in research and product development (PD) and provides a single-use solution for monoclonal antibody (mAb) manufacturing.

Integrating Human Factors Into The Product Development Process: BD Intevia 1 mL Two-Step Disposable Autoinjector

At BD, human factors activities are conducted throughout the phase-gated product development process. For the BD Intevia 1 mL autoinjector, nine studies focusing on the device/user interface were conducted over the course of the project to identify and to eliminate or reduce the risk of error so that the device can be used safely.

Case Study For Developability Assessment Of Three Therapeutic Antibodies

This poster reviews studies for three monoclonal antibody (mAb) drug candidates utilizing a panel of small-scale, fast, predictive tests used to evaluate therapeutic antibodies’ developability.

Small Molecule APIs: Aligning Drug Strategy With Partnering Strategy

Development of novel small molecule APIs is increasingly turned over to outsourced partners who have become the primary drivers of the product’s overall development and go-to-market strategy. 

Biologics Drug Substance And Drug Product Preferred Provider Use

ISR data show the majority of those who outsource biologics drug substances and drug products use a preferred provider approach to outsourcing, and average about four CMOs on their lists.

Establishing Process Data Visibility In Contract Manufacturing Networks

This joint webinar with Accenture explores the challenges within today’s increasingly decentralized and complex supply chain and how sponsors and CDMOs plan to address them.

Not Your Same Old CDMOs

2020 seems to have been the year of the evolution of the atypical, newfangled CDMO. Outsourced Pharma editor Louis Garguilo talks about this trend and what makes these new models all the rage.