Newsletter | September 15, 2020

09.15.20 -- Making FMEA More Robust With HACCP

 
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CCI Testing Method Development For Vials Stored At -80C, Using Headspace Gas Ingress

Sterile pharmaceutical products, such as live viral vaccines, gene therapies, and products that contain active cells, often require deep cold storage, either at -80°C or cryogenic temperatures (-196°C) to maintain stability and/or activity. This article describes the development of such a test method for vials stored at - 80°C.

Breaking Down Pharma’s Silos For The Sake Of Data Integrity

As the pharmaceutical industry strives to make a digital transformation through connected data, companies must figure out how to effectively use and share their insight with other stakeholders across their network.

Guidance For Optimization Of A Realā€Time qPCR Assay

Optimizing the formulation of reagents for your quantitative polymerase chain reaction (qPCR) assay requires careful experimental design that looks across several performance factors for each reagent formulation tested. These performance factors include assay specificity, reliability, repeatability, linearity, sensitivity, and efficiency.

Insight From An Expert: A Chemist’s Secrets To Efficient API Scale-Up

The more efficient your API synthesis, the lower your cost of goods. The author shares his tricks of the trade for route selection, equipment choice, manufacturing techniques, and more.

Cultivation Of CHO Suspension Cells And SEAP Expression In The HyPerforma Rocker Bioreactor

This application note describes the cultivation of Chinese hamster ovary (CHO) suspension cells in the wave-mixed Thermo Scientific HyPerforma Rocker Bioreactor with a maximum working volume of 5 L. Using chemically defined minimal media, cell densities of up to 16.4 x 106 cells/mL were achieved. 

Raw Material Variability: The Need For Deeper Process Understanding

Principles and methods for biopharma development and manufacturing are well established, but the increased molecular diversity and a drive for higher productivity brings new challenges to process developers.

Impurity Identification In Small Molecule APIs

Management of the impurity profile of an active pharmaceutical ingredient (API) is essential to manufacturing drug substances successfully in a manner that meets sponsor expectations for timelines and quality.

Synthesizing Success: Six Principles For Getting Pharmaceutical Development Right From The Start

This paper highlights six keys that pharma and biotech companies should keep in mind when selecting a partner to synthesize an API to ensure the development process tracks toward success.

Polymeric PDC Technology: The Value Of Cyclic Olefins Drug Containers In Designing Autoinjectors For Highly Viscous Formulations

The design of autoinjectors for increasingly viscous and high-volume drug requirements presents significant challenges in today’s pharmaceutical market. New materials offer opportunities to overcome these challenges. This article discusses the value of cyclic olefins drug containers in the design of autoinjectors for highly viscous formulations.

3 Trends That Could Improve Air Cargo Shipping In Pharma Supply Chain

There are three technology trends that could help mitigate air freight logistics risks, reduce costs related to transportation issues and/or temperature excursions, and deliver high-quality drugs safely.

The Role Of pH And Residue In Pharmaceutical Cleaning

A great deal is known about how pH affects aqueous critical cleaning. Typically, alkaline cleaners are used on oily residues and acidic cleaners are used on inorganic residues.

A Guide To Achieving Better Insight With Accurate Data

How can you ensure your business is generating accurate, high-quality data that facilitate effective reporting, and allow you to gain deeper insight? We’ve put this ebook together to guide you through the journey of data management and help you gain unrivalled insight for future research and experiments.

Smooth Transition: What Specialty Drug Manufacturers Should Know About Bridging The Gap From Clinical To Commercial Packaging

As a steady stream of specialty drugs enter the marketplace, pharmaceutical companies are seeking new supply chain solutions to ensure that an uninterrupted supply of these breakthrough treatments reach patients. One solution for the challenges of packaging specialty products is low- or small-volume commercial packaging.

Reducing Risks With Single-Sourced Modular Cleanrooms

Life sciences industries require highly controlled environments for drug research development and manufacturing.

CMO Meets Serialization And Aggregation Demands With Case Aggregation Kit

Pharm Germany GmbH operates as a contract manufacturing organization (CMO) producing and packaging pharmaceuticals for customers, which are then distributed in more than 150 countries. This aggregation solution allows them to successfully supply pharmaceuticals to markets that demand serialization or aggregation.

The Integration Of Milling, Blending, And IBC Material Handling Systems For API Production

A multipurpose facility for API production had various requirements including milling, micronizing, packaging, and the possibility to blend various batches together before or after milling. A set of material handling products from Dec Group was the solution.

Experimental Design And Statistical Tools For Nondestructive Package Integrity Testing Systems

This short podcast focuses on the experimental design and statistical tools we use with nondestructive package integrity test systems. PTI’s Veripac inspection systems are deterministic test methods for package integrity testing that produce reliable and robust quantitative test data.

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