Biopharmaceutical Analysis

Garima Thakur is a graduate student in the Department of Chemical Engineering at the Indian Institute of Technology New Delhi.

Anurag S. Rathore is a professor in the Department of Chemical Engineering at the Indian Institute of Technology Delhi and a member of 

l's Editorial Advisory Board, Tel. +91.9650770650, asrathore@biotechcmz.com.

Articles

The need for real-time monitoring and control has spurred the development of new analytical tools.

Near Infrared Spectroscopy as a Versatile PAT Tool for Continuous Downstream Bioprocessing

The companies intend to design and implement algorithms for the early stages of research for drug discovery and development of drug candidates to treat Alzheimer’s disease.

Roche and Cambridge Quantum Computing Use Algorithms for Early Alzheimer's Drug Research

The acquisition strategically expands SPT Labtech’s offering in sample management for life sciences.

SPT Labtech Strengthens Automation Services with BioMicroLab Acquisition

The new ultra-sensitive second-generation micro-chip technology is a key enabler in advanced single-cell proteomics workflow.

PharmaFluidics Offers Second-Gen µPAC Technology for Single Cell Proteomics

PathoQuest will apply its experience in viral safety testing and quality control of biologics for mitigating the risk of adventitious agent contamination in biopharmaceutical manufacturing.

PathoQuest Joins CAACB Consortium as Viral Safety Expert

Nexelis’ recent acquisition of GSK’s Marburg, Germany-based vaccines clinical bioanalytical laboratory expands its bioanalytical capabilities.

Nexelis Expands Bioanalytical Services with Bioanalytical Lab Acquisition

Jared Auclair is associate dean, Professional Programs and Graduate Affairs, and director, Biopharmaceutical Analysis Training Lab, Northeastern University.

Lori Stansberry is marketing manager, Pharma & BioPharma, Thermo Fisher Scientific.

Vendors are finding ways to address the increasingly complex analytical challenges in the biopharmaceutical industry to further biotherapeutic development.

Is Collaboration the Key to Accelerating Biotherapeutic Development?

Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.

Clear understanding of what exactly the biomolecule entails is essential.

Using Protein Characterization to Support Regulatory Submissions

A novel PTA technology captures more than 95% of the genomes of single cells, providing more uniform, accurate, and reproducible single-cell analysis data.

BioSkryb Discusses First Data Demonstrating Improved Accuracy in Single Cell Analyses

The expansion of the companies’ partnership will integrate lead optimization efforts to advance cancer immune therapy drug discovery.

Expansion of APEIRON Biologics and Domainex Partnership will Advance Cancer Drug Discovery

The partners have established PathoQuest, Inc., a US subsidiary, and will construct an NGS-based testing lab at Charles River’s Wayne, PA, site. 

Charles River and PathoQuest Establish US Subsidiary for NGS-based Testing Lab 

Feliza Mirasol is the science editor for 

Early detection and more sensitive methods of detecting adventitious agents are becoming increasingly critical in bioprocessing.

Complex Modalities Require More Sensitive Adventitious Agent Testing

Samsung Biologics has adopted Solentim’s cell seeding and cell metric platforms at its new R&D center in San Francisco, CA. 

Samsung Biologics Incorporates Solentim’s Cell Line Development Technology into New R&D Center 

Mogrify’s new technology platform, EpiMOGRIFY, can predict cellular switches important for determining cell identity, cell maintenance, directed differentiation, and cell conversion.

New EpiMOGRIFY Technology Platform Offers Development Support for Allogeneic Cell Therapies

With the presentation of research supporting the use of PTA technology, BioSkryb also launched its ResolveDNA platform for commercial use at ASHG 2020, held virtually on Oct. 27–30, 2020.

Novel Single-Cell Whole Genome Amplification Technology Made Commercially Available at ASHG 2020

Christopher Burgess is with Burgess Consultancy, "Rose Rae," The Lendings, Starforth Barnard Castle, Co. Durham, DL12 9AB UK.

Analysts should understand how a monograph, together with the associated general notices and general chapters, relate to their responsibilities under good manufacturing practices.

Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?

Glycoengineering is growing in importance as a technique to improve antibody therapeutic efficacy, safety, and product quality. 

Glycoengineering Shows Promise for Enhancing Antibody Therapeutics

Amy R. Barker (barker_amy_r@lilly.com), is senior quality advisor with Eli Lilly and Company in Indianapolis, IN.

Dawn E. Sailer is associate quality advisor with Eli Lilly and Company, Indianapolis, IND.

Brian W. Pack is senior research advisor with Eli Lilly and Co., Indianapolis, IN.

Mark D. Argentine is senior research advisor with Eli Lilly and Company in Indianapolis, IN.

This article discusses standardized analytical method-transfer kits that have been developed to streamline method transfer and site certification at Eli Lilly. Use of these kits has been proven to improve overall efficiency and to reduce cost and time requirements for method transfer. 

Streamlining Method Transfer Across Global Sites

The company’s new CytoML Experiment Suite fully automates each stage of the flow cytometry data lifecycle, allowing for clearer data visualization and analysis.

Aigenpulse’s Data Analysis Suite Automates Flow Cytometry

Toshihiko Otsubo is principal scientist of Biologics Process Development, 

Pharmaceutical Sciences, Takeda Pharmaceutical.

Shinji Tsuji is associate director at Biopharmaceuticals Process and Product Development, Pharmaceutical Sciences, Takeda Pharmaceutical.

Yoshiaki Miko is Associate Director of Biologics & New Modalities Development, Pharmaceutical Sciences, Takeda Pharmaceutical.

Tetsuya Moritake is associate director of Project Leadership & Operations, 

Pharmaceutical Sciences at Takeda Pharmaceutical.

director and head of Manufacturing Operations of Biogics Process Development

The increased use of single-use bags in biologic manufacturing poses the risk of pinholes and other defects that cannot currently be tested for.

Analytical Methods