Standardized analytical method-transfer kits streamline method transfer and site certification.

Method Transfer Across Global Sites

Complex modalities put pressure on detection and testing processes.

More Sensitive Adventitious Agent Testing 

A clear understanding of the biomolecule is essential.

Protein Characterization for Regulatory Submissions

Topic

Articles

Demand for specific advanced laboratory skills creates a positive employment market.

Talent-Driven Market for Laboratory Technicians

Using rDNA technology to synthesize production of proteins and peptide hormones, the biotech startup has achieved synthetic production of insulin, potentially lowering insulin cost by 30%. 

rBIO Hits Key Lab Milestone with Synthetic Production of Insulin

After a hectic 2020, biopharma looks to deliver on COVID-19 vaccines and move other promising therapies forward.

Biopharma Gets Back to “New Normal” Business

Essential bio/pharma employees show hard work and dedication can pay off, for patients.

Compensation Does Not Necessarily Align with Job Satisfaction

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

Ramesh Kumar is a graduate student at the Indian Institute of Technology, Delhi.

Manidipa Banerjee is a professor in the Kusuma School of Biological Sciences at the Indian Institute of Technology, Delhi.

Anurag S. Rathore is a professor in the Department of Chemical Engineering at the Indian Institute of Technology Delhi and a member of BioPharm International's Editorial Advisory Board, Tel. +91.9650770650, asrathore@biotechcmz.com.

Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency. 

Virus-like Particles as Therapeutic Moieties of the Future

Dolomite Microfluidics and MilliporeSigma have begun a collaboration to release off-the-shelf microfluidic device kits for the fabrication of PLGA particles.

Dolomite Microfluidics Partners with MilliporeSigma for Microfluidic Device Kits 

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 

The shift to single-use technologies is driving the need for innovation in PAT-friendly sensor technologies.

Single-Use Sensors Increase Process Understanding

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

Complex Modalities Require More Sensitive Adventitious Agent Testing

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?

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

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

Pall has introduced a 24-well filter plate that can perform cell clarification and sterilization in one step.

Pall’s 24-Well Filter Plate Performs Cell Clarification and Sterilization

The company recently launched its OmniTop Sample Tubes adjustable volume sampling system, a single-use system that allows for exact sampling.

Avantor OmniTop Sample Tubes Offers Adjustable Volume Sampling

The new filters extend column life and reduce contamination while simplifying sample preparation.

Pall Introduces Acrodisc Syringe Filters with Universal, Water-Wettable PTFE Membranes

The new chromatography columns provide enhanced separation for high order aggregates and macromolecules.

Tosoh Bioscience Introduces TSKgel UP-SW Aggregate UHPLC/HPLC Columns

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

Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.

Biopharmaceutical Analysis

Method Transfer Across Global Sites

More Sensitive Adventitious Agent Testing

Protein Characterization for Regulatory Submissions