Newsletter | November 5, 2020

11.05.20 -- Mammalian Biomanufacturing Industry Supply & Demand Trends

Featured Editorial
Industry Insights
The Significant Need For Flexible Aseptic Filling And Isolation Systems In Pharma

Primary packaging of pharmaceutical products often involves filling containers (including vials, syringes, and bottles) with powders and/or liquid solutions. Manufacturing staff, equipment, and premises are all subject to stringent quality controls for good reason: patient safety. This document intends to provide information on the latest status, trends, and technologies in parenteral filling equipment.

Container Closure Integrity Testing: The Importance Of Sensitivity, Automation, And Efficiency

This article will explore the need for sensitive, reliable, and automated container closure integrity (CCI) testing technologies and how existing deterministic solutions can help achieve optimum quality assurance goals in CCI for pharmaceutical manufacturers.

Container Closure Integrity Testing Utilizing Mass Extraction Technology

Mass extraction tests are nondestructive and offer higher measurement sensitivity. In addition, the instruments are efficient, offer short test times, and are more accurate than many of the other methods.

Process Characterization: Ready For The FDA? (Article)

Realizing the benefits of process characterization requires proper planning and application of a comprehensive process characterization strategy.

Considerations When Cleaning Your Tablet Presses And Tablet Tooling

Implementing a cleaning procedure is essential to maintaining your tablet tooling and presses. Keeping tools clean also decreases premature tool, turret, and cam wear, and also reduces the risk of product cross contamination. 

Bridging The Divide: Streamline The Process Development And Tech Transfer Process

Preparing drug products for tech transfer can be a daunting task. This article describes how the advantages of the AST GENiSYS system can streamline the tech transfer process by enabling efficient drug development activities and process data collection.

Particle Engineering For Inhalation Drug Delivery

Inhalation-based drug products play a critical role in addressing the rising incidence of respiratory diseases around the globe. Particle engineered-based formulations are key in designing and developing effective dry powder inhaler (DPI)-based drugs. This article discusses key parameters for choosing the right particle engineering approach to meet DPI target product profiles.

Pharma Manufacturer Uses New Data Tools To Help Increase Efficiencies

Digitization offers the promise to connect everything on the plant floor but will also bring challenges such as storing, capturing, contextualizing, visualizing, and analyzing the tremendous volumes of data. 

Analytical Quality By Design Using Design Of Experiments

This poster demonstrates how a panel of analytical assays designed for a monoclonal antibody (mAb) used different design of experiment (DoE) approaches for rigorous statistical design and analyses for assay development.

Strategic CDMO: Bringing End-To-End Solutions For Faster Drug Development

Patheon's Bill Weiser discusses how a new generation of CDMOs have positioned themselves to provide strategic solutions that not only complement product development but also drive therapies to patients faster.

Technical Considerations For Developing Oral Solids (Part 1)

In a two-part series, four oral solids experts from Pfizer CentreOne’s global network and partner organizations discuss the technical considerations to be aware of. In this first installment, we look at the importance of technical groundwork and understanding excipients in the early stages of your project.

Comparator Local Sourcing For Clinical Trials

The growing demand for comparators is causing many supply chain managers to explore available sourcing options. This paper examines the fundamentals of local sourcing, including the benefits and challenges, and the circumstances under which local sourcing can be a sound decision. 

How To Avoid Last-Minute CMC Roadblocks To Approval

Problems can arise when sponsors face balancing available budget and time resources between clinical and chemistry, manufacturing, and controls (CMC) needs. This is a brief overview of the CMC information required by regulatory authorities and highlights why planning and budgeting for key CMC considerations early in the development process are essential for success.

How Shorter Needles With Thinner Walls Are Set To Improve The Injection Experience In Chronic Care

A look at how new prefillable glass-based syringes with shorter, 8 mm needles and thinner wall cannula technology are set to improve the injection experience for subcutaneous drug delivery in chronic care.

HyPerforma Glass Bioreactor For Fermentation Of Saccharomyces Cerevisiae

This application note describes the cultivation of Saccharomyces cerevisiae in the Thermo Scientific HyPerforma glass bioreactor with a maximum working volume of 2.0 L. Using the chemically defined medium D, it was possible to produce up to 5.33 g/L of dry biomass using 40 g/L glucose.

Effects Of Feeding Strategy On CHO Cell Performance In Fed-Batch Cultures

This application note demonstrates a fed-batch process for a Chinese hamster ovary (CHO) cell line producing a monoclonal antibody (mAb). The results emphasize the importance of an appropriate feeding strategy to optimize cell growth and productivity.

Moisture Headspace Analysis For Efficient Scale-Up Of Freeze-Drying Capacity And Validation

A vaccine production facility needed to replace an old freeze dryer in an existing facility during running operations. With the application of nondestructive headspace moisture analysis, small-scale proof-of-concept studies were used to minimize project risk and the number of full-scale runs in the freeze-drying validation process.

Scale-Up Considerations For Large-Scale Peptide Manufacturing

The chemical and operational challenges and risks of peptide synthesis are magnified when considering the transition from lab-scale preparation to large-scale plant manufacturing. This webinar identifies aspects of scale-up peptide manufacturing that the CordenPharma Colorado manufacturing site has focused on for large-scale development and implementation of commercial peptide APIs. 

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