Annwesha Roy

L- Asparaginase activity estimation through ELISA- based colorimetric assay (Indooxine assay): Conducted research on different L-Asparaginase formulations administered to patients in TATA Medical Center as part of their treatment for acute lymphoblastic leukaemia (ALL).

• Clinical Monitoring: Monitored Asparaginase activity in patient samples, ensuring therapeutic activity levels (≥100 IU/L). Generated regular patient reports to aid clinician decision-making. Administration was discontinued for patients with subtherapeutic activity levels, reducing cost burden and risk of toxicity.
• Assay Optimization and SOP Development: Optimized Indooxine assay for various native and PEGylated Asparaginase formulations. Developed standard operating procedure (SOP) to ensuring consistent and accurate assay performance. Conducted extensive quality assurance for different formulations.
• Laboratory Standard Establishment: Worked on establishing reliable recombinant Asparaginase laboratory standard for Indooxine assays with specific activity matching innovator product to ensure accurate activity estimation across different Asparaginase formulations.
• Training and Mentorship: Conducted training sessions on Indooxine assay for researchers from external institutions, observership program participants, and internal research groups.

ELISA-Based Anti-Asparaginase Antibody Detection:

• Protocol Standardization: Standardized and optimized indirect ELISA protocol for anti-Asparaginase antibody detection against PEGylated Asparaginase formulations administered to patients in TATA Medical Center, Kolkata, India.
• Screening patient samples: Longitudinally tracked patient samples for anti-Asparaginase or anti-PEG IgG antibodies to correlate Asparaginase associated toxicities and subtherapeutic activity levels with antibody formation.

Patient Sample Biobanking and Inventory Management:

• Sample Processing: Processed and biobanked plasma samples from from paediatric and adult ALL patients administered different formulations of Asparaginase.
• Inventory Management: Maintained detailed inventory for easy retrieval of patient samples from different timepoints.

Deviation Tracking: Created and maintained deviation log to track all assay and sample collection/biobanking-related deviations.

Literature review: Created and maintained literature tracker to make relevant reference journals easily accessible to the team.

Research Discussions:

• Engaged in regular journal clubs with colleagues in clinical research unit to discuss clinical trial papers of significance for Asparaginase studies.
• Engaged journal clubs with clinical proteomics unit to gain knowledge on plasma proteomics.

L-Asparaginase Activity Estimation (Indooxine Assay):

Trained in Indooxine method for Asparaginase activity estimation.

• Quality Assurance: Performed extensive quality assurance for generic PEG-Asparaginase (Asviia), focusing on parameters such as assay accuracy, precision, recovery and sensitivity.
• Assay Method Validation: Generated assay validation report post quality assurance.
• Optimization: Optimized Indooxine assay for PEGylated Asparaginase formulations to enhance assay sensitivity and successfully enhanced lower limit of quantification from 37 IU/L to 5 IU/L.

Patient Sample Biobanking and Inventory Management

• Sample Processing: Trained in processing and biobanking patient plasma samples.
• Inventory Management: Maintained detailed inventory of laboratory supplies and patient samples from different time points to support pharmacokinetic studies.

Research Discussions

• Presentation: Presented internship research in lab meeting as part of internship program.
• Participation: Actively participated in regular journal clubs and meetings with fellow researchers to discuss papers of interest, project updates, challenges, and lessons learned during ongoing activities.

Scientific Publications and Academic Writing

• Assisted researchers and academics with manuscript preparation, editing, and proofreading.
• Provided writing assistance for academic assignments across various fields.

Literature Review and Qualitative Research

• Conducted comprehensive literature reviews to support academic writing and publication services.
• Compiled and analyzed qualitative data to enhance quality and depth of academic manuscripts.