Newsletter | January 7, 2020

01.07.20 -- Rebels Vs. Clones: Constructive Dissent In The Pharma Industry

Featured Editorial
Rebels vs. Clones: Constructive Dissent In The Pharma Industry
By Martin Lush, global VP of health sciences, NSF International

The pharma industry is in the middle of an identity crisis, but not in the way you may think. Rather than a period of uncertainty and confusion typically brought on by a change in role or expectations, this crisis is far more insidious. I liken this alarming trend to the essential belief system conflict in a popular movie series you may have heard about over the past 45 years or so.

Pharmacy Compounding vs. Manufacturing For Clinical Studies: The Regulatory Perspective
By Stephen Langille, senior microbiology consultant, ValSource, Inc.

FDA requirements and compendial standards for pharmacy compounding and outsourcing continue to evolve, and the FDA has different requirements for products prepared through pharmacy compounding practices as compared to those manufactured for use in clinical studies.

Industry Insights
2020 Cold Chain Forecast: Ushering In The Next Decade Of Change
Article | By Kevin Lawler, Pelican BioThermal

As we cross the threshold into a new decade in 2020, it’s a time to take stock of the significant changes that transformed the pharmaceutical cold chain industry during the past decade. The following four predictions are what we see on the immediate and not-so-distant horizon that will continue to transform the pharmaceutical and cold chain industries.

Advanced Digital Sensors Improve Lifecycle Management
White Paper | By Steven Smith, Endress+Hauser, Inc.

Digital sensors make it possible for the same sensor, lifecycle management software, and SOPs to work in both lab and production environments.

Using Flow Sensors As Diagnostic Tools In Pharmaceutical Manufacturing
Article | By Craig Correia, Festo Corporation

Investigating the source of consumption increase early on and correcting the problem will improve the performance and uptime of all automated plant equipment.

Container Closure Integrity Testing: Risks And Methods
Application Note | By Dennis Seibert, Advanced Test Concepts (ATC) by Pfeiffer Vacuum

An overview of integrity tests where a high sensitivity is required to prevent the risks of stability failure of highly moisture-sensitive drugs or the risk of biological ingress of sterile parenteral drugs.

Automated Cell Bleed Control In An Intensified SU Rocking Motion Bioreactor
Application Note | By Svea Grieb, Johannes Lemke, Markus Schulze, and Jens Matuszczyk, Sartorius Stedim Biotech

Intensified processing represents a major trend in the biopharma industry because it increases the productivity of single-use (SU) facilities while decreasing the manufacturing footprint. Here's how to optimize the approach.

Guide Clients Through Drug Development With Intelligent Collaboration
Q&A | A Q&A with JoyL Silva, Pfizer CentreOne Contract Manufacturing

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

Porosity And Its Influence On Pharmaceutical Tablet Dissolution Profiles
Article | Micromeritics Instrument Corporation

Porosity is a good prediction of how liquids enter into the tablet matrix, and the expectations can be validated by experiment. Dissolution rates do not exclusively depend upon porosity; other predictors are also valid including solubility, surface area, and particle size. In addition to carrying out dissolution testing, establishing porosity, surface area, and other characteristics are key to establishing the optimal dissolution rate.

How A New Factory-In-A-Box Is Helping Scale Up Manufacturing Of Viral Vector-Based Therapies To Reach More Patients
Article | GE Healthcare Life Sciences

Manufacturing viral vector-based therapies such as vaccines and gene and cell therapies is complex, but a new manufacturing solution helps solve those challenges.

High-Throughput Preformulation Development Platform For Biologics
Poster | Catalent

Typically, in early development, the quantity of protein available for studies is limited, and a dataset is required to expedite Tox- and IND-enabling stability studies. In this study, a high-throughput formulation development approach for sample preparation and sample analysis was implemented in order to enable a simple and less labor-intensive screening of a broad range of conditions in considerably less time, making the formulation process more efficient and economical.


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