Biopharmaceutical Analysis

This column presents a data case study of a laboratory refrigerator and its qualification performance over five days, with important lessons for using average and individual results, as well as user requirements.

Method choice is crucial to when seeking answers to biosimilar characterization questions.

The authors summarize the current regulatory expectations regarding the number of PPQ batches required and provide potential approaches that can be used to determine and justify the number of PPQ batches.

While the measurement of the toxicity of leachables is not always a required parameter, the information collected during these studies could inform future bioprocessing runs.

Electronic systems can remove opportunities for individuals to make mistakes or to manipulate the data.

Optimize practices and meet requirements using electronic data integrity systems.  

Short tandem repeat profiling is the most validated method to confirm cell line identity and avoid misidentified or cross-contaminated cell lines.

Sartorius Stedim Biotech combined the company’s ambr 15 bioreactor system with the Nova BioProfile FLEX2 cell culture analyzer for laboratory experiments.

Phenomenex opened a new manufacturing and development facility in CA for the company’s gas chromatography columns.

This article reviews systems and processes that enable a laboratory to approach troubleshooting in an effective way, while also taking a proactive, preventive approach to managing atypical laboratory scenarios.

This article summarizes the approaches, challenges, and future perspectives for the characterization of N-glycans in biopharmaceutical products.

Increased understanding of potential impurities has spurred efforts to standardize monitoring procedures.

How statistical methods and novel indices can be used to monitor and benchmark variability, to guide continuous improvement programs.

An increase in biologics raises awareness of particle generation and its role in negative patient outcomes.

Operated by BioOutsource, Sartorius’ subsidiary, the Glasgow, UK-based service center will offer physicochemical properties and structural attributes testing and allow clients to perform structural and functional analyses in parallel.

Can bioprocessing runs be consistently replicated in an inherently variable production environment?

This article provides an overview on important aspects related to bracketing strategies in Japan.

Endress+Hauser’s Memosens CPS171D pH electrode for hygienic and sterile biopharmaceutical processing provides stable measurements even after multiple cleaning and sterilization cycles.

Chromatography modeling can enhance bioprocessing efficiencies.

FTIR can successfully measure key characteristics of therapeutic proteins in a single step.

The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics

Understanding the purpose of the biological indicator can guide the development of an effective sterilization process.

The agency cited Morton Grove Pharmaceuticals for inadequate quality control procedures.

The decision to use disposable bioreactors is now driven by commercial rather than technological considerations.

Manufacturing for originator molecules is restricted by regulations, but drug makers can exploit newer technologies for the manufacture of biosimilars.

Although best practices are key, advances in integrated informatics platforms and automation can make it easier to ensure data integrity and improve overall laboratory efficiency.

Process characterization and model building are essential skills and are required for modern drug development.

A multi-pronged approach to raw materials testing can help mitigate the risk of future contamination events.

Despite limitations, mass spec is having an impact on biologic drug development and manufacturing.

Extraction studies demonstrate approaches for evaluating single-use bio-pharmaceutical manufacturing materials.