Bhumit A. Patel
YOU?
Author Swipe
View article: Implementation of Innovative Process Analytical Technologies to Characterize Critical Quality Attributes of Co‐Formulated Monoclonal Antibody Products
Implementation of Innovative Process Analytical Technologies to Characterize Critical Quality Attributes of Co‐Formulated Monoclonal Antibody Products Open
Characterizing co‐formulated monoclonal antibodies (mAbs) poses significant challenges in the pharmaceutical industry. Due to the high structural similarity of the mAbs, traditional analytical methods, compounded by the lengthy method deve…
View article: Attribute Analytics Performance Metrics from the MAM Consortium Interlaboratory Study
Attribute Analytics Performance Metrics from the MAM Consortium Interlaboratory Study Open
The multi-attribute method (MAM) was conceived as a single assay to potentially replace multiple single-attribute assays that have long been used in process development and quality control (QC) for protein therapeutics. MAM is rooted in tr…
View article: Qualification of Identity, Quality-Attribute Monitoring and New Peak Detection in An Improved Multi-Attribute Method with Lys-C Digestion for Characterization and Quality Control of Therapeutic Monoclonal Antibodies
Qualification of Identity, Quality-Attribute Monitoring and New Peak Detection in An Improved Multi-Attribute Method with Lys-C Digestion for Characterization and Quality Control of Therapeutic Monoclonal Antibodies Open
The use of Multi-attribute method (MAM) for identity and purity testing of biopharmaceuticals offers the ability to complement and replace multiple conventional analytical technologies with a single mass spectrometry (MS) method. Method qu…
View article: STUDY ON INDIVIDUAL'S PREFERENCE ABOUT ONLINE CAB BOOKING SERVICES
STUDY ON INDIVIDUAL'S PREFERENCE ABOUT ONLINE CAB BOOKING SERVICES Open
India is a country in the process of evolving., and it has been discovered that as a result of this development, In India, the need for taxi services is growing.. The introduction of an organised car rental system using modern technologies…
View article: Determination of protein concentration in downstream biomanufacturing processes by <scp>in‐line</scp> index of refraction
Determination of protein concentration in downstream biomanufacturing processes by <span>in‐line</span> index of refraction Open
Protein concentration determination is a necessary in‐process control for the downstream operations within biomanufacturing. As production transitions from batch mode to an integrated continuous bioprocess paradigm, there is a growing need…
View article: New Peak Detection Performance Metrics from the MAM Consortium Interlaboratory Study
New Peak Detection Performance Metrics from the MAM Consortium Interlaboratory Study Open
The Multi-Attribute Method (MAM) Consortium was initially formed as a venue to harmonize best practices, share experiences, and generate innovative methodologies to facilitate widespread integration of the MAM platform, which is an emergin…
View article: Structural Characterization of the Aggregates of Gemtuzumab Ozogamicin
Structural Characterization of the Aggregates of Gemtuzumab Ozogamicin Open
The preparation of antibody drug conjugates (ADCs), particularly those containing hydrophobic payloads, may promote aggregate formation. The aggregate (high molecular mass species, HMMS) is an impurity that must be controlled in the final …
View article: Multi-angle light scattering as a process analytical technology measuring real-time molecular weight for downstream process control
Multi-angle light scattering as a process analytical technology measuring real-time molecular weight for downstream process control Open
For many protein therapeutics including monoclonal antibodies, aggregate removal process can be complex and challenging. We evaluated two different process analytical technology (PAT) applications that couple a purification unit performing…