Newsletter | April 6, 2020

04.06.20 -- Assessing The Impact Of COVID-19 On Regulatory Interactions, Inspections, & Audits

  Pharmacokinetic Strategies In CNS Drug Discovery

The discovery and clinical development of drugs for many central nervous system (CNS) disorders have remained elusive despite the dramatic increase in our understanding of the central nervous system over the last two decades. New drugs targeting important CNS diseases have higher failure rates than for other diseases, both preclinically and clinically. This article discusses successful pharmacokinetic (PK) approaches employed by GVK Bio in the recent past that may help in CNS-targeted drug discovery and development efforts.

Featured Editorial
Assessing The Impact Of COVID-19 On Regulatory Interactions, Inspections, And Audits
By Laurie Halloran, CEO and chairwoman of the board, Halloran Consulting Group, Inc.

While we have not seen any significant delays in regulatory approval of life sciences products to date, the impact of COVID-19 on regulatory interactions, inspections, audits, and global health authorities is continuing to evolve.

Are You Ready For A DSCSA Audit? 5 Steps To Ensure The Answer Is “Yes”
By Mike Karhoff and Mark Karhoff, Ten Count Consulting, LLC

During an FDA audit, you're asked questions about the U.S. Drug Supply Chain Security Act and how you offer and share your T3 data with downstream trading partners. Do you answer confidently, or hold your breath and gulp?

Industry Insights
Not Everyone Loves Surprises: Know Your ADC’s Critical Quality Attributes
White Paper | By Omar Lamm and Martin De Cecco, MilliporeSigma (Product Characterization)

Combating the challenges of developing and manufacturing antibody-drug conjugates (ADCs) requires robust product characterization throughout all phases of development.

The Economics Of Biomanufacturing Strategies: Can You Afford Failure?
Case Study | By Joseph Phillips, Ph.D., ArmaGen, Inc

Prior to making critical strategy decisions, a small biotech company completed an economic evaluation of manufacturing options to ensure it was selecting the best fit for its drug development needs. 

Simplifying Aseptic Contract Manufacturing: Part 2 — Documentation
Article | Singota Solutions

Explore the impacts of a fully integrated filler/isolator system with built-in decontamination technology operating principles, which combine to radically reduce and simplify manufacturing documentation. 

Flow Chemistry vs. Batch Processes
White Paper | GVK Biosciences

Batch processing of new chemicals requires versatile, qualified equipment to perform different unit operations. Continuous flow chemistry is emerging as an effective chemical synthesis tool.

Pairing Data Connectivity And Automation Ease Tech Transfer And Scale-Up
White Paper | GE Healthcare Life Sciences

This article outlines how connectivity and a comprehensive automation solution can ease technology transfer and scaling from process development to final manufacturing scale.

Collegium Pharmaceutical’s Innovative Approach To Abuse Deterrence
Case Study | Thermo Fisher Scientific

To address the ongoing public health crisis related to opioid abuse, Xtampza ER has been developed to resist the ability of abusers to tamper with the product and alter the route of administration.

Hyper-Productivity In Your mAb Purification Step
Application Note | JSR Life Sciences

Learn how a tenfold increase in productivity of 200 g/L/h compared to the industry norm was possible through an intensified Protein A capture process.

Conductivity Testing Of Mixing Systems
Application Note | Meissner Filtration Products

This technical bulletin highlights the results of conductivity testing to characterize recirculation mixing performance of single-use systems deployed in QuaDrum rigid outer containers (ROCs).

Capture OTC Market Share For Geriatric And Pediatric Patients
Webinar | Thermo Fisher Scientific

This webinar discusses how the unique properties of gelatin have been used to develop chewable softgel formulations for the pediatric and geriatric patient populations. 

  BIO International Convention

June 8 to 11, 2020 | San Diego, CA

Take your business BEYOND expectations at the world's largest biotechnology partnering event! Join over 17,000 biotech and pharma professionals from around the world for four days of BIO One-on-One Partnering, world-class education sessions, and the expansive BIO Exhibition featuring 1,800+ innovative companies.

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