Newsletter | October 11, 2021

10.11.21 -- 9 Pitfalls To Avoid In Data Integrity in Pharmaceutical and Device Development & Operations

Featured Editorial
Industry Insights
Debunking Myths And Misconceptions About Softgels

Here, we take a look at some common myths about softgels and explore why drug developers may want to reconsider their go-to delivery methods.

Innovation And Flexibility During The COVID-19 Pandemic

The biopharma industry has been challenged to discover and develop new diagnostic tests, treatments, and vaccines to help resolve the pandemic. Learn how one CDMO embraces the challenge.

Increase Drug Discovery Productivity, Optimize SPR Data Interpretation

The need to increase efficiency and productivity has led scientists to develop a machine learning solution that can optimize the way that developers analyze and characterize their early drug candidates.

How To Build A Robust Packaging Strategy For Rapid Commercialization

Look at the elements involved in building a robust packaging strategy and the key technical considerations in packaging design and operational planning for products of various sizes.

Swifter, Safer Dynamic Axial Compression (DAC) Column Turnover

This article explains an easy-to-implement system that would increase both efficiency and safety during the DAC column turnover process.

Spray-Dried Dispersions Enable Local Delivery For Lung Cancer

Spray drying is particularly advantageous for manufacturing particles in the inhalable range of 1-5 microns. Learn more about spray drying through two case studies of inhaled dry powders.

Raw Materials In Upstream Bioproduction: Challenges And Solutions

Media formulations supporting the production of biologics require global sourcing from different suppliers. Here’s how to ensure a reliable raw material supply and to mitigate risk from variability. 

Alternatives To In Vivo Assays For Biosafety Testing Of Biologics

Even as alternative methods such as PCR and NGS have emerged, in vivo tests have stubbornly remained a central part of testing. Here we examine current in vivo methods and explore modern alternatives.

Facilitating 21 CFR Part 11 Compliance With Bio4C Orchestrator

How Bio4C Orchestrator Software provides technology to support requirements for electronic records and provides a detailed “rule-by-rule” analysis for 21 CFR Part 11 and Annex 11 in tabular form.

Nanogold Particles Using The Nicomp System

This application note demonstrates how the Nicomp Z3000 system is ideally suited for determining size and zeta potential of gold nanoparticles.

Fc-Fusion Purification Performance: Amsphere A3 vs. Other Protein A Resins

The dynamic binding capacity (DBC) and purification of Fc-fusion and bispecific Ab proteins are compared on A3 and other commercial Protein A resins, with a discussion of the molecular basis for A3’s high affinity for target molecules.

Exosome Research Products Version 2 Guidebook

Exosomes  have recently been attracting research interest. This guidebook is a useful resource for exosome researchers seeking high purity isolation.

Process Intensification: Key Considerations And Expert Insights

In this e-book industry leaders discuss their experience implementing process intensification strategies as they relate to unique organizational goals. 

Guide Clients Through Drug Development With Intelligent Collaboration

This article is a recent discussion with the General Manager of Pfizer CentreOne, regarding what it’s like to lead an embedded CDMO within one of the largest pharmaceutical companies.

Outsourcing Impact Of Focus On Innovative Treatment

In Q4 2017, ISR asked a follow-up question to respondents who agreed that their company’s focus on developing new innovative treatments will impact its outsourcing practices.

A Roadmap For Early Development To Commercial Manufacturing

Learn how to avoid common pitfalls in the transfer and scale-up process using an integrated approach, with industry experts sharing key considerations when planning for scale-up of a development program.

Flexible Isolator Technology: Containment That Works

This webinar focuses on applications where flexible isolators have been used, including containment assessments to confirm performance and ergonomic benefits. 

Identifying And Mitigating Potential For Immunogenicity, Immunotoxicity

Explore the challenges of assessing the immuno-safety profile when moving a drug candidate to first-in-human (FIH) studies, including key considerations and pitfalls to avoid along the way.

Increase Upstream Bioprocessing Efficiency With Process Analytics

The upstream bioprocess contributes significantly to product quality and manufacturing efficiency. This webcast presents strategies for inline process analytics aimed at automated feed control.

Improving Manufacturing Productivity At Abbott Nutrition

Abbott’s nutrition business manufactures a wide variety of science-based nutrition products. Here we review how the company uses Big Data and analytics to improve manufacturing productivity.

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