The landscape of biopharmaceutical analysis features different analytical requirements in terms of instrumentation and type of analysis (QC, RTRT, and in-process). One of the questions that often ...crops up for routine analysis is "How much replication is enough?" Should all the samples be run in triplicate irrespective of the type of analysis, or does the type of analysis (such as charge or size variants) have any bearing on the number of optimal replicates?
...aggregation has to be monitored throughout process development and manufacturing of a mAb product. ...the protein is formulated using ultrafiltration/diafiltration and filled in its final form.
This installment of "Biotechnology Today" reviews and discusses a systematic approach for the formation of sigmoidal gradients for the analysis of biopharmaceutical proteins together with two case ...studies. The first application involves high performance liquid chromatography (HPLC) separation of the various product-related variants of a microbial-expressed biotherapeutic, granulocyte colony stimulating factor (GCSF). The second case study involves separation of the charge heterogeneity related variants for a monoclonal antibody (mAb) biotherapeutic product. In both cases, the use of the sigmoidal gradient successfully reduced the analysis time significantly while retaining the selectivity and resolution.
...Indian biosimilars are gaining acceptance even in conservative international markets; for example, Biocon-Mylan's biosimilars Ogivri (trastuzumab), Fulphila (pegfilgrastim), and Semglee ...(Insulin-glargine) have been approved by United States Food and Drug Administration (USFDA) and have been launched in the United States. ...academic research should be oriented as per the current challenges and future needs of the ecosystem. ...academic research in strengthening in-house capabilities is essential to break the current dependency on technologies exported, such as bioreactors, biosimilar clones, and culture media (to name a few). For many of the countries, accessibility to basic health care services is a major bottleneck, and due to inadequate health care systems and policies, the reach of the general public to biopharmaceutical products remains poor.
This installment of "Biotechnology Today" focuses on developing a rapid method for reversed-phase high performance liquid chromatography (HPLC) analysis of granulocyte colony stimulating factor ...(GCSF) purity for process analytical technology (PAT) applications. It also highlights an approach that one could take to achieve faster HPLC analysis. PUBLICATION ABSTRACT
In the first part of this series, we discussed the various quality attributes that are pertinent to a biotherapeutic. In this issue, we will present the current and evolving practices that are being ...used for analysis of these attributes.
The potential for the presence of multiple impurities and variants in biotherapeutic products highlights the need for having an arsenal of orthogonal analytical techniques that together can yield a ...reliable and accurate characterization of the product. Here, in the first part of this two-part series, we discuss the various quality attributes that are pertinent to a biotherapeutic. In part II, we will present the current and evolving practices that are being used for analysis of these attributes.
Each mode is based on a different underlying mechanism and together make HPLC a powerful tool in the analytical arsenal. Since typical HPLC applications involve separation of product from ...productrelated variants and impurities that have very similar physicochemical properties as compared to the product, the elution strategy has a significant impact on the quality of separation. ...a concave gradient was performed at high flow rates (3 mL/ min) using a short monolithic column (Figure 2c).
