Newsletter | May 3, 2021

05.03.21 -- The Role Of Analytical R&D In Sterile Fill/Finish

 

Albert Einstein believed that time was relative and an illusion of our making. That may explain why we think we can save time, lose time, and even waste time, because, after all, it is our creation. But can we really manipulate time?

 

Despite our habit of characterizing efficiency as time-saving, it remains finite — 60 seconds, 60 minutes, 24 hours, seven days. We understand the finite nature of time and that a few additional hours cannot be added to a day. However, we can do things differently in the time we have.

 

Better outcomes can be achieved when we are smarter about how we spend our time, such as calculating thrust into the start of a project, pursuing rare disease therapies, streamlining sterile production operations with better analytical R&D, and preventing time-consuming errors with due diligence. 

Accelerate The Start Of Your Outsourced Pharmaceutical Project
 

Getting through the initial stages of a complex pharmaceutical project that is outsourced to a CDMO can be like launching a rocket. Incorporating a few key practices early in an outsourcing relationship can deliver the thrust needed to get projects moving quickly.

The Value Of Orphan Drug Designation
 

More than 90% of rare diseases still have no FDA-approved treatment, even though rare diseases affect more than 25 million Americans. Despite the opportunities in the orphan drug market, there are challenges that may act as barriers to entry.

The Importance Of Analytical R&D To Sterile Fill/Finish
 

Parenteral drug product development and production rely on the careful integration of supporting elements, with analytical support as key. Analytical support is required at all stages of the product’s life cycle, from early development to commercialization.

Preventing Cross Contamination: Operating Beyond cGMP
 

One critical outcome universally accepted by the pharmaceutical industry is that cross contamination of drug substances and products in manufacturing lines cannot occur. However, the conditions driving modern pharmaceutical development and manufacturing have increased the risk of cross contamination.

Meet The Scientist: Irina Prudnikova
 

Analytical research and development (R&D) works in close collaboration with formulation and process R&D to support the overall development process. Irina’s team is often the catalyst for transforming a development candidate into a viable drug formulation that improves patients' lives.

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