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July 10, 2018
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   Scale-Up and Tech Transfer for Lyophilized Products

There are few challenges when increasing the scale of production for a solution formulation, but the challenges drastically increase when the formulation is intended for lyophilization. Considering the differences in equipment design and capability will aid in the scale-up and technical transfer of new processes from laboratory-scale to full-scale and in transfers between manufacturing sites.

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» Industry News
 
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» Featured Articles
A Yearly Review of NDAs: 2017
Over the years, the Prescription Drug User Fee Act (PDUFA) has authorized the USFDA to collect user fees from industry to facilitate the review process for certain human drug applications. The fifth ... read more »
Raw Materials, Excipients and APIs
Pharmaceutical raw materials include both active pharmaceutical ingredients (APIs) and inactive ingredients or excipients. APIs are bulk drugs that are pharmaceutically active and generate a desired ... read more »
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» Featured Video
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  Watch Video: Pfanstiehl - Global Leader in Bioprocessing Solutions
Pfanstiehl specializes in isolation, purification, custom synthesis and scale-up development of regulated, high purity and low endotoxin Injectable Formulation Ingredients, Pharmaceutical ... read more »
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  Watch Video: Brandon Zurawlow AMRI Booth Interview at Interphex 2017
Albany Molecular Research Inc (AMRI) is a pharmaceutical services organization offering Discovery/Development solutions, and Drug Product and API Manufacturing. read more »

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» Featured Whitepaper
How Molded Manifold Assemblies Prevent Leaks and Costly Consequences
Traditional fluid transfer systems for biopharm and pharmaceutical applications rely on a multitude of complex components to move liquids from one ... read more »
Process Development for Lyophilized Products
Identifying the failure points for a product is a necessary part of product development, and enables the development scientist to design a ... read more »
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| Events
EVENT
  16th Annual Cold Chain Global Forum
Philadelphia, PA –  09/24/2018
At the 16th Annual Cold Chain Global Forum, we will gather the top pharma supply chain executives and suppliers to address end-to-end supply chain ... event details »
EVENT
  9th Clinical Quality Oversight Forum
Philadelphia, PA –  10/10/18
Join ExL Events October 10–12 in Philadelphia for the 9th Clinical Quality Oversight Forum. This event provides an interactive forum for senior-level ... event details »
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