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September 04, 2018
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   Development of a Lyophilized Biosimilar

Case Study: The patents for a number of parental biologic formulations are destined to expire in the United States between 2016 and 2027. This provides development opportunities for many companies, but also provides significant challenges. The biosimilar must closely match the analytical testing requirements for the biologic developed by the innovator company, as well as many other possible requirements.

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» Industry News
 
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» Featured Articles
Designing Phase-Appropriate Stability Study Programs for Drug Substances and Drug Products
Stability is a critical quality attribute of pharmaceutical products and is a function of many factors, including the active drug substance itself, the excipients used within the formulation, the ... read more »
HORIZON LINES: A Quarterly Review of NDAs – January-March 2018
This quarterly review on New Drug Applications contains data for applications approved for the first time during the first quarter of 2018, which includes New Molecular Entities (NMEs) and new ... read more »
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» Featured Partners
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  Full-Service Aseptic Fill Finish and Lyophilization Services

With the infrastructure and know-how to successfully complete development and commercialization projects from beginning to end, and an extensive track record of overcoming development challenges and protecting valuable assets, LSNE can help you minimize mistakes and maximize opportunities for success. read more »
» Featured Video
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  Watch Video: A Discussion with Dr. Thomas Page, VP Engineering and Asset Development at Fujifilm Diosynth Biotechnologies
Watch Video: A Discussion with Dr. Thomas Page, VP Engineering and Asset Development at Fujifilm Diosynth Biotechnologies read more »
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  Watch Video: Pyramid Laboratories Facility Tour
PYRAMID Laboratories, Inc. is a CDMO, focused on parenteral drug products, that offers comprehensive pipeline of services to pharmaceutical and biotech companies. read more »

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» Featured Whitepaper
Considerations for Development of a Lyophilized Biosimilar
The patents for a number of parental biologic formulations are destined to expire in the United States between 2016 and 2027. This provides ... 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
  ChemOutsourcing 2018
Long Branch, NJ –  09/17/2018
ChemOutsourcing is the largest USA-based API show attracting annually 700-800 chemists and business development personnel from the pharmaceutical, ... event details »
EVENT
  DCAT Week ‘19
New York City, NY –  03/18/2019
DCAT Week is the premier business development event for companies engaged in pharmaceutical development and manufacturing and related industries. It ... event details »
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