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Article Contract Manufacturing Through the Years
Contract Manufacturing Through the YearsHow has the bio/pharmaceutical contract manufacturing industry evolved over the years and what does the future hoHow has the bio/pharmaceutical contract ma…

Article The New World of Biopharmaceutical Manufacturing
Industry experts discuss the single-use revolution and changes to upstream and downstream processing equipment. By Jennifer Markarian …

Article Fusion Proteins Pose Manufacturability Challenges
The unique structures of fusion proteins lead to expression, heterogeneity, and stability issues. By Cynthia A. Challener Fusion proteins are engineered proteins that contain domains from di…

Article Extractables Studies for Single Use Systems Used in ADC Manufacturing, Part 1
Single‑use (SU) systems have great potential in antibody‑drug conjugates (ADC) manufacturing. The use of organic solvents in the ADC process might , however, raise questions about potential leac…

Article Mechanistic Modeling of Preparative Ion-Exchange Chromatography
By Anurag Rathore, Vijesh Kumar Among the various downstream processing unit operations that are used for purification of biotech products, chromatography is uniquely capable of providing resolu…

Article Single-use Bioreactors Have Reached the Big Time
“Today, a continuous process can last significantly longer than current fed-batch processes, which means that there are higher expectations and a need for a high-level of sensing analytics, providing …

Article Automating Bioprocesses
Automation of stainless-steel systems and single-use systems differs in complexity. By Jennifer Markarian Both upstream and downstream biopharmaceutical processes have conventionally used st…

Article Impact of Manufacturing-Scale Freeze-Thaw Conditions on a mAb Solution
The objective of this study was to assess the impact of manufacturing-scale, freeze-thaw conditions on aggregation and subvisible particle formation of a monoclonal antibody solution (mAb-A; IgG1) u…

Article Ensuring the Biological Integrity of Raw Materials
By Catherine Shaffer Contamination with microbes, mycoplasma, viruses, and other adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can o…

Article The Tide Stays High
Robust venture capital investment gives CDMOs and CROs a positive outlook for 2017. By Jim Miller A year ago, the outlook for contract services was a little uncertain. Equity markets’ appeti…

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