Newsletter | May 21, 2020

05.21.20 -- Should You List All Manufacturing Facilities In Your Drug Application? A Question Of Regulatory Ethics

Featured Editorial
Industry Insights
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 AST's GENiSYS system can streamline the tech transfer process by enabling efficient drug development activities and process data collection.

Fermentation Optimization: Using Comparative Statistics To Enhance Large-Scale Process Productivity

Using a case study, the author demonstrates how comparative statistical analysis enabled his team to improve the yield of a component used in API synthesis by more than 2.5 x 108 U/batch.

Trends In Combination Products

Sometimes patients need to use combination products and delivery systems to deal with a chronic condition or to ease an acute condition. To ensure compliance with regulations and overcome challenges, it is essential to remain familiar with the changing regulations, and to receive additional insights from various sources.

Sponsor Challenges When Outsourcing Sterile Injectables

ISR asked outsourcers of sterile injectable drug products to identify their biggest challenge when outsourcing to CDMOs/CMOs. Here's a look at the resulting nearly four-way tie.

Pharmaceutical Manufacturer Improves Chromatography And Batch Comparisons Using Data And Analytics

Having the right applications to store and contextualize data is imperative, but being able to obtain business value by accessing and interpreting it quickly and effectively can have a huge impact on decision making and, ultimately, the business’s bottom line.

The Evolution Of Supply Chain Security: Increased Focus On Raw Material Variability

Qualifying two suppliers, increasing capacity, implementing a scorecard methodology for strategic suppliers, and surveying suppliers for their number of production lines are all important ways to guarantee steady supply of materials and technologies — but we must ensure close attention is also paid to raw materials.

Risk Mitigation For Material Transport: The Impact Of Reusing Shippers

Ensuring your material is stored under appropriate conditions is only half the battle in preserving its integrity. Equally as critical is the precarious process of transporting your material to its destination, safely and in the same condition it was sent in. 

2D And 3D Predesigned Solutions For Storage And Shipping

Single use in cGMP production requires enhanced assurance of supply and product performance. Innovative bioprocessing bag technology meets these challenges for every process step and application.

Use Of Nunc Cell Factory Equipment To Accelerate Workflows And Increase Product Consistency

Scaling up adherent cell culture can be a difficult process for many vaccine, cell therapy, gene therapy, and viral vector manufacturers. Some cells can alter their properties if they are not cultured in specific conditions. The simplest way to mitigate all these risks is by using a multilayered vessel in a closed system with automation equipment.

Single-Use Flexible Containment Systems For Charging And Offloading Pharmaceutical Powder Transfer Operations

Don’t risk operator exposure and potential contamination with untested or unproven single-use valve technologies. 

Managing Clinical Ancillary Supplies At Global Scale

Clinical ancillary management expertise helps a biopharma company oversee a large, global trial from start through finish.

Specialized Drug Product Packaging Solutions

With pharma companies developing and bringing more advanced medicines and niche orphan drugs to the market, there has been a notable change in drug product packaging requirements. Developed by commercial packaging experts, this eBook explores some of the biggest trends in the pharmaceutical packaging market.

Reducing Risks With Single-Sourced Modular Cleanrooms

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




ISR Reports is a full-service market research company and sister company of Pharmaceutical Online. Operating exclusively in the pharmaceutical and pharmaceutical services industres, their syndicated and custom market research capabilities enable their customers to make smarter, more informed business decisions.


Topics include: Manufacturing practices and models, trends and technology, commercialization, dosage forms, excipients, outsourcing strategies, and more.


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