Biopharmaceutical Analysis

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

Articles

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.

Proposing a New Method of Detecting Pinholes in Single-Use 

Current and newer biologic modalities pose increasingly complex challenges to the detection and characterization of protein aggregates.

Risky Business: Assessing Protein Aggregation Grows Increasingly Challenging

Thermo Fisher Scientific is increasing access to cry-electron microscopy with the help of contract research organizations.

Thermo Fisher and CROs Expand Access to Cryo-EM

The award will help a bioanalytics startup commercialize instrument technology for pharmaceutical antibody manufacturers.

SBIR Awards $1.4-Million Grant to Accelerate Antibody Manufacturing Technology 

The company has launched a residual GMP-compliant test and dual sourcing opportunity designed to increase compliance and reduce risks for ATMP manufacture.

Polyplus-transfection Launches Residual Test for Transfection Reagents 

The investment will allow for the expansion of analytical R&D efforts and will support the company’s reference materials business.

MilliporeSigma Invests $20 Million in New Switzerland Laboratory

The company’s SLIM technology has been a part of the company’s accelerated growth by offering enhanced R&D analytics.

MOBILIon’s SLIM Technology Enhances R&D Analytics

Benton Cartledge is associate research scientist, PPD Laboratories, 8551 Research Way, Suite 90, Middleton, WI 53562.

Jason Carmichael is assistant scientist, PPD Laboratories, 8551 Research Way, Suite 90, Middleton, WI 53562.

Nathan Haag is a scientist, PPD Laboratories, 8551 Research Way, Suite 90, Middleton, WI 53562.

Eric Hansen is a scientist, PPD Laboratories, 8551 Research Way, Suite 90, Middleton, WI 53562.

Travis Lato is an assistant scientist, PPD Laboratories, 8551 Research Way, Suite 90, Middleton, WI 53562.

Data from migration kinetics studies can be used to develop models that predict levels of leachables and extractables at different temperatures and time points.

Predicting Extractables and Leachables from Container Stoppers

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

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.

EDQM Publishes New General Chapter in European Pharmacopoeia Supplement 10.3

Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.

Analytical Assays Determine Biosimilar Product Quality

Safeguarding against microbial contamination requires rapid detection and innovative technology.

Detecting Microbial Contamination in Bioprocessing

The company has provided updates on its COVID-19 tests under development with Adeptrix and Cytiva, respectively.

Avacta Provides Updates on COVID-19 Antigen Diagnostic Test Development

Advanced data analytics, including statistical modeling and machine learning technique, can enable more efficient and reliable bioprocesses.

Understanding Commercial Cell Culture Process Performance Variation Through Advanced Data Analytics

Tools such as manufacturing execution systems, artificial intelligence, and software innovations are useful for enhancing data integrity protection.

Challenges, Tools, and Strategies for Data Integrity Protection

The extension of the company’s product offerings to include the anti-certolizumab pegol antibodies offers critical reagents for the development of assays for TNF alpha inhibitor biologics and their biosimilars.

Analytical Methods