Newsletter | August 5, 2019

08.05.19 -- Applications For Single-Use In Biosimilar Development

Featured Editorial
4 (More) Microbiological Root Cause Analyses Lessons From Sherlock Holmes
By Paula Peacos, ValSource, Inc.

Sherlock Holmes was keenly aware of bias's impacts on investigative work. Applying more of Holmes’s famous observations and investigative principles can uncover hidden bias and greatly increase an investigator’s chance of finding that elusive definitive root cause.

Applications For Single-Use Systems In Biosimilar Development
By Jerry Martin

As originator drug batches get smaller and are made in single-use systems, biosimilars will follow suit. Newer processes have increased productivity tenfold, eliminating the need for 10,000-liter to 20,000-liter bioreactors and broadening applications for single-use bioreactors.

Industry Insights
In-House Versus Outsource: A Decision-Making Guide
White Paper | By B. Rosenblatt, Ph.D., SME Biotech Consulting, and D. Kenyon, Ph.D., Thermo Fisher Scientific

Biopharma executives must consider how outsourcing fits into their development and production strategy. Here’s a step-by-step guide to help make that decision.

Viral Clearance: 7 Chromatography Column Considerations
Article | By Linnea Troeng, GE Healthcare Life Sciences

Viral clearance studies are a critical part of the production of biologics. However, performing studies that are accurate and cost-effective can be challenging. Here are seven things to consider while performing your next chromatography viral clearance study.

3 Steps To Strengthen Your Supply Chain Partnerships
Article | By Travis Hudson, Singota Solutions

If you’re struggling to achieve legitimate value, take advantage of this three-step process to strengthen your supply chain partnerships.

Answering Today’s Pharma Dilemma Of Build Or Buy
Article | By Charles Christy, Lonza Pharma & Biotech

A new business and operating model may address the build or buy dilemma, offering an innovative and agile way to manage demand uncertainty and reduce the risks associated with early investment decisions.

Precise Control Of Gas Flows Within The BIOSTAT® B-DCU
Application Note | By Sebastian Ruhl, Diana Hesse, Sönke Rosemann, and Ute Husemann, Sartorius Stedim Biotech

To meet the oxygen demand of cells, a stable pO2 control is an essential part of every cultivation. The objective of this application note is to demonstrate the performance of a new generation of mass flow controllers in the BIOSTAT B-DCU bioreactor system. Several comparative cell cultivations were performed.

A Strategy To Remove Formulation Development From The Critical Path During Biologics Development
Q&A | Catalent

Biopharmaceuticals tend to be highly unstable. Therefore, as the product development program progresses to Phase 3 clinical stage, formulation development is required to ensure drug product quality and stability during manufacturing, storage, and clinical administration. During this Q&A, Dr. Jun Lu, director, analytical development, discusses how Catalent Biologics utilizes automation, specifically the Uncle platform, during formulation development.

Pharmacokinetic Strategies In CNS Drug Discovery
White Paper | GVK Biosciences

New drugs targeting important central nervous system (CNS) diseases have higher failure rates than drugs for other diseases, both preclinically and clinically. This paper discusses some successful pharmacokinetic (PK) approaches that we have employed in the recent past and may help in CNS-targeted drug discovery and development efforts.

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