Newsletter | May 19, 2020

05.19.20 -- Introduction To Science- And Risk-Based Cleaning Validation Using ASTM E3106 & E3219

 
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Scalable Strategies For Parenteral Dosage Form Selection

Understand the strategies that can be employed at the different stages of development when choosing parenteral dosage forms.

Container Closure Integrity Test Method Development Using Headspace Gas Ingress

With no “gold standard” container closure integrity (CCI) test, learn how creating a toolbox of CCI testing methods will allow you to be best prepared for every situation.

Relying On Third-Party Organizations For Strategic Equipment Acquisitions

One of the most critical decisions for a pharmaceutical company is the choice to outsource operations, which leads to determining the optimal supplier with which to partner. When choosing an organization, a company must prioritize risk minimization and choose a dependable supplier with a strong track record. A facility is only as strong as the equipment that it runs, and production is only as effective as the equipment operators.

Preventing Sticking And Picking Through Tablet Design

Sticking or picking issues are often not detected. Prevent unanticipated problems during scale-up and full-scale production by considering tablet compression issues before tablet designs are finalized.

LV Scale-Up Workflow In Single-Use Bioreactors For GMP Compliance

Cost-effective manufacturing of lentiviral vectors (LVs) at commercial scales has proven difficult and remains a pressing issue for the marketing of therapies that depend on their application.

Assurance Of Quality Supply For Single-Use Predesigned Solutions

Read how resin specifications, process qualification, and process controls established at all stages of the manufacturing process can ensure quality, change control, and business continuity.

High-Volume Manufacturing: Essential Points To Consider Before You Scale Up

To successfully scale to high-volume manufacturing, planning is required for streamlining the production process and minimizing the changes that could add unnecessary time and expense to the process.

Aseptic Blow-Fill-Seal Technology vs. Traditional Aseptic Processing

Blow-fill-seal (BFS) technology has been gaining increasing worldwide acceptance in the parenteral drug marketplace, replacing traditional glass vial processing in a growing number of applications.

Keys To Driving Consistent Quality In Contract Manufacturing

Complex products and supply chains present plenty of opportunities for failure, especially when new products are being developed and launched. This article discusses the key ingredients for the robust and advanced quality planning that is essential to quality in contract manufacturing.

Meeting Accuracy And Safety Objectives With Inspection And Weighing Technologies

New approaches to selecting and using inspection and weighing equipment can help pharmaceutical processors better meet accuracy and safety objectives.

Measuring The Stiffness Of Hydrogels For Tissue Growth

Hydrogels are very compliant materials suitable for tissue engineering in various areas of biological and clinical research. Appropriate and effective application of hydrogels for specific cellular regeneration often requires precise knowledge of their mechanical properties. This application report focuses on the measurements of mechanical deformation and creep properties of polyacrylamide hydrogels using the Anton Paar Bioindenter.

HPAPI Processing And Drying Suite For Operator And Product Protection

A two-part enclosure consisting of a single-pass air flow glove box enclosure and a nitrogen purge enclosure was designed to provide protection to the operator and product.

Pharma Services Global Network

At Thermo Fisher Scientific, our people pride themselves on solving your pharmaceutical drug development and supply chain distribution challenges. Our objective is to help speed your molecule through early-phase trials to prepare you for commercial success faster. This ebook explains how our team can provide comprehensive support to help streamline the end-to-end process.

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