fulltext.study @t Gmail

Formulation and manufacturability of biologics

Paper ID Volume ID Publish Year Pages File Format Full-Text
16559 42508 2009 7 PDF Available
Title
Formulation and manufacturability of biologics
Abstract

An important challenge in the pharmaceutical development of a biologic is the optimization of safety and efficacy while ensuring the ability to manufacture the drug while maintaining quality and stability. The manufacturing process consists of several operational steps referred to as ‘unit operations’ where the biologic is subjected to different stresses and conditions that may compromise quality and stability. Moreover, recently the requirement for the development of subcutaneous formulations for high dose drugs, such as monoclonal antibodies, at high protein concentrations has created additional challenges for many of the unit operations. These challenges can be mitigated by modification of the manufacturing process and/or development of formulations to prevent degradation. In particular, formulations have been designed to minimize protein aggregation and decrease viscosity, which has led to successful manufacture of the biologic.

First Page Preview
Formulation and manufacturability of biologics
Get Full-Text Now
Don't Miss Today's Special Offer
Price was $35.95
You save - $31
Price after discount Only $4.95
100% Money Back Guarantee
Full-text PDF Download
Online Support
Any Questions? feel free to contact us
Publisher
Database: Elsevier - ScienceDirect
Journal: Current Opinion in Biotechnology - Volume 20, Issue 6, December 2009, Pages 708–714
Authors
,
Subjects
Physical Sciences and Engineering Chemical Engineering Bioengineering
Get Full-Text Now
Don't Miss Today's Special Offer
Price was $35.95
You save - $31
Price after discount Only $4.95
100% Money Back Guarantee
Full-text PDF Download
Online Support
Any Questions? feel free to contact us