Newsletter | July 28, 2020

07.28.20 -- What Can The Antibiotic Shortage Teach Us About Weathering API Supply Disruptions?

 
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Can Your In-House Strategy Handle Uncertainties Of Biologics Development?

A company must be able to withstand the highs and lows of biologics development. To avoid costly mistakes and wasted efforts, a company must prepare for surprises along the drug development pathway.

2020 Cold Chain Forecast: Ushering In The Next Decade Of Change

As we cross the threshold into a new decade in 2020, it’s time to take stock of the significant changes that transformed the pharmaceutical cold chain industry during the past decade. 

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

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.

Optimizing Process Efficiency In Upstream Manufacturing

Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency — a key goal for biopharma production.

Utilizing Single-Use Powder Handling To Reduce Contamination

Read how upgrading to modern single-use powder handling gets a product to market without time wasted on complicated weigh and dispense steps, cleaning validations, or powder in the air and in the suite.

How The Extrusion Process Impacts The Quality Of Blow/Fill/Seal Products

A collaborative study involving Cardinal Health, Inc. and Air Dispersions Ltd. has been carried out to further the understanding of the extrusion process and its impact upon the quality of blow/fill/seal products.

What You Should Know About Pharmaceutical Cleaning Validation

This paper outlines the basics of cleaning validation and also discusses the kinds of support services you should seek from your supplier of critical cleaning products in order to optimize your cleaning validation process.

Novel Hydrophobic Interaction Chromatography Resins For Next-Generation Biotherapeutic Challenges

To solve downstream separation and purification challenges for many biotherapeutic modalities, a suite of hydrophobic chromatography resins has been developed to cover a wide range of hydrophobicity. 

Is Wurster Processing The Right Choice For My Multiparticulate Modified Release Dosage Form?

Wurster processing is a common and appropriate choice for multiparticulate formats. But is it the best one? This paper outlines what you need to consider when determining whether Wurster processing is right for your multiparticulate modified release dosage form, as well as general information to assist in discussions with your CDMO.

Identifying Enhanced Needle Solutions And Integrated System Solutions To Serve The Chronic Disease Market

In addition to wider uptake of home care, an increase in the number of biologics being manufactured, many by the same company, is driving ongoing innovation in drug delivery systems. Identifying enhanced needle solutions and offering integrated system solutions to serve the chronic disease market is a great step toward addressing improved patient outcomes and adherence.

The Case For A Facility Monitoring System

While there are some that choose to install a facility monitoring system just because regulatory guidance states one should be installed and used, many, given the choice, would choose not to.

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 drive therapies to patients faster.

An Engineered Platform For High-Loaded Dosage Forms Of Amorphous Solid Dispersions

This poster outlines a novel engineered platform for the formulation of high-active-loading oral solid dosage forms containing amorphous solid dispersions (ASDs) of a rapidly crystallizing drug with a low glass-transition temperature (Tg).

Key Considerations For Medical Kit Design

Designing packaging for your drug product can be very daunting, especially when you consider the ever-changing regulations by various countries. If you consider that the three main functions of packaging are to protect the drug product, enable ease of use, and communicate, then these can generally be applied across all pack formats, albeit tailored to your specific product/medical kit requirements.

Recirculation Flow Testing A Biocontainer

A common challenge of using rocker bioreactors in perfusion mode is the transfer of air into the recirculation pathway. Here, a new anchored dip tube designed to prevent the problem is evaluated.

How Pfizer Enabled Production Analysis Across The Organization

The operational data at the Pfizer Small Molecule Division was siloed and only available within the physical building, increasing manual work, hindering collaboration, and creating data latency issues.

Efficient Track And Trace Solutions For International Pharmaceutical Company

Serialization and aggregation solutions allow Swiss-based Acino Pharma to serve its international customers quickly and reliably.

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