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American Pharmaceutical News In Review
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April 20, 2022
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  Reliable & Traceable Preparation of Buffers and Solutions for Antibody Analysis

Antibodies are subject to various issues due to chemical and physical instabilities. These effects may change the pharmacokinetics of antibodies. Because of the potential instabilities, pharmacopeias dictate produced antibodies must be thoroughly tested before applying for treatment of patients.

US Pharmacopeia Chapter 129 lists analysis methods for therapeutic antibodies. Each of these methods require the preparation of buffers and solutions, many require the precise weighing of multiple components.

Download this application highlight from Sartorius to learn about the relationship between therapeutic antibodies and analytical balances.


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» Industry News
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  Takeda Announces Approval of Nuvaxovid® COVID-19 Vaccine for Primary and Booster Immunization in Japan
Takeda has received manufacturing and marketing approval from the Japan Ministry of Health, Labour ... read more »
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  Enhertu Granted Priority Review for Patients with Non-Small Cell Lung Cancer
AstraZeneca and Daiichi Sankyo received notification of acceptance of the supplemental Biologics ... read more »
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  FDA Accepts Investigational New Drug (IND) Application for Phase 3 Study of Imlifidase in Anti-GBM Disease
Hansa Biopharma AB, “announced the acceptance by the U.S. FDA of Hansa’s Investigational New Drug (... read more »
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  Agilent Joins the National Institute for Innovation in Manufacturing to Advance Biomanufacturing
Agilent Technologies Inc. has joined the National Institute for Innovation in Manufacturing to ... read more »

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» Infographic
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  Reducing Risk in Drug Development
Reducing Risk in Drug Development
Proactive microbial detection using real-time Total Organic Carbon (TOC) and Conductivity technologies offer better process control and can mitigate ... read more »
» Featured Articles
Pharmaceutical P.I.N. Points - Patent Innovation News
The purpose of this column is to highlight and summarize recent key patents in the pharmaceutical arena issued by the US Patent Office in December ... read more »
Inspectional Readiness for Aseptic Cleanroom Operations
When the FDA conducts inspections of aseptic drug manufacturers, they cover systems and areas within systems that present the greatest risk of product... read more »
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» Featured Video
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  On-Demand Webinar: Sophisticated Formulation Approaches for Insoluble Drug Candidates
The webinar will explain the role nano-formulations play to accelerate the drug discovery/development process. It will also outline a formulation ... watch »
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  On-Demand Webinar: Mitigating Risk in Manufacturing with Rapid Microbial Monitoring in Pharmaceutical Water
In this webinar we discuss examples of real-world conversations as pharmaceutical customers grapple with true microbial contaminations within their ... watch »

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» Featured Products
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  alpha300 R Confocal Raman Imaging System
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» Featured Whitepaper
Whitepaper: Comprehensive Pure Water Guide for Pharmaceutical Engineers
In today’s pharmaceutical facilities the availability of purified water is essential. While the domestic consumer considers tap water to be “pure”, the pharmaceutical end-user regards it as grossly ... read more »
Analyses of Antibody Drugs Using Inert Ultra High Performance Liquid Chromatography
This article introduces analyses of monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) for quality control using an inert UHPLC system that is extremely resistant to mobile phases ... read more »

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| Events
EVENT
  SMi’s 22nd Annual Pain Therapeutics Conference
London, UK –  05/04/2022
SMi’s 22nd Pain Therapeutics Conference will cover the leading advances in pain therapeutics, exploring late development clinical trials, novel ...
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EVENT
  Cannabis Science Conference
Long Beach, CA –  05/18/2022
Cannabis Science Conference is the world’s largest and fastest growing scientific and medical cannabis event. Join us in Long Beach, CA on May 18th ...
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