Newsletter | July 27, 2020

07.27.20 -- Are You Ready? FDA's Transition From Computer System Validation To Computer Software Assurance

 
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Industry Insights
Novel Uses For Oral Solid Doses Driving Lifecycle Management Strategies

With few potential blockbuster drugs in the pharma pipeline right now, drug companies are increasingly looking at other options to meet the needs of patients and increase revenue in the oral solid dosage arena.

How To Adapt Your Biomanufacturing Process To Maximize Production

Today’s novel solutions and technologies can push the boundaries of drug development and offer critical advantages in an increasingly competitive industry. 

Putting The “Process” Into Process Characterization

Done correctly, process characterization reduces the risk of manufacturing failures and regulatory delays. Scientists at the AbbVie Bioresearch Center (ABC) have established a platform approach to process characterization that has been proven effective as it has been used to support the approval of several marketed products.

Solutions To Today’s Biomanufacturing Challenges

With more complex molecules in development, changing capacity needs, uncertain forecasts, and increased competition, the market demands flexibility and innovative approaches to today’s challenges.

Scale Matters: A Flexible Approach To Demand Uncertainty

Mid-volume capacity bioreactors offer agility in an unpredictable industry and balance the cost of goods as a program prepares to launch.

A Bridge Over Troubled Water: The Journey To Serialization Compliance

This regulation from the FDA outlined serialization and traceability requirements spread over the course of 10 years with preparation for each phase accumulating into a potentially high overall price tag.

Oral Solid Dose Regulatory Hurdles And How To Approach Them

In your quest to meet the regulatory requirements for your oral solids project you may encounter significant hurdles. Anticipating these early on and thoroughly planning your approach can help. In this blog, experts discuss common regulatory challenges and how to approach them.

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