Mahesh Tambe Email & Phone Number

Reykjavík, Capital Region, Iceland

Aurangabad, Maharashtra, India

• Development and optimization of Enzymatic Conversion Reaction (ECR) to produce target protein and reduce the non-specific enzymatic cleavage (impurity) of Insulin Glargine.• Development and optimization of Cation Exchange Chromatography (CIEX) to remove protein-related impurities of Insulin Glargine.• Optimization of Reverse Phase Chromatography (RPC) to remove hydrophobic peptide impurities of Insulin Glargine.• Isolation and manufacturing of multiple Insulin impurities at the pilot scale to support the analytical method qualification and SST requirements.• Process fit evaluation of a downstream process for Lispro molecule.• Execution of Pilot end-to-end downstream batches for impurity mapping and its evaluation of clearance capacity by each unit operation of the downstream process.• Analysis and data interpretation of process intermediate samples in order to map the impurity profile using UPLC and HPLC RP chromatography.• Design, coordinate and execute laboratory studies related to downstream processing.• Responsible to collate, evaluate data and authoring technical reports with scientifically supported conclusions.• Support laboratory organization and maintenance as well as project-based activity and resource planning.

Ahemdabad

A) Development and optimization of monoclonal antibody fragment downstream process • Development of solubilization process for optimum denaturation and reduction of inclusion bodies (IBs) • Development of Refolding process using QbD approach to enhance the refolding yield.• Development and optimization of Tangential flow filtration (TFF) at two stages for volume reduction and product concentration. • Development and optimization of multiple downstream unit operations using the design of experiments (DOE) approach which includes Anion Exchange Chromatography (AIEX), Hydrophobic Interaction chromatography (HIC), and Cation Exchange Chromatography (CIEX) to remove the product and process-related impurities.•Planning and execution of consistency batches for evaluation of process performance at Pilot scale.B) Tech Transfer of monoclonal antibody fragment downstream process to manufacturing scale • Planning and support of the execution of engineering batch, to demonstrate the process performance at the Manufacturing Scale (2000 L)• Study of buffer and process intermediate hold time study• Process Performance Qualification (PPQ) of developed downstream process in the Manufacturing suite C) Scale Down Model evaluation• Scale-down model (SDM) study of downstream unit operation like IB solubilization, TFF, Refolding, different, CIEX, HIC, and AIEX chromatography.• Freeze-thaw study for process intermediates (PI) to access its stability and impact on quality attributes.C) Documentation• Author and review of the tech transfer documents such as BMR, TTD, IPQC Specs etc.• Data collation, interpretation, presentation & authoring/reviewing of developmental protocols and reports of different studies like Engineering reports, Consistency batches, SDM etc.D) Other Activities• Core team member for the digital transformation and implementation of the electronic lab notebook (eLN) project in R & D.

Ahemdabad, Gujarat

A) Tech Transfer of downstream process to manufacturing scale for fusion class therapeutic protein• Execution of satellite batches in R & D for process performance evaluation.• Tech transfer to the manufacturing suite (1000 L scale)• Planning and support in the execution of Process Performance Qualification (PPQ) batches at a manufacturing scale of 1K Litres for Indian and semi-regulated marketB) Development and Tech Transfer of the downstream process of monoclonal antibody (Mabs) for regulated market• Planning and support in the execution of Process Performance Qualification (PPQ) batches/ Clinical Trial at scale of 1K Litres of harvest.• Planning and authoring tech transfer documentation process which includes Technology transfer documents (TTD), Process Information Note (PIN), Batch manufacturing record (BMR).• Execution of Scale down model (SDM) studies for multiple downstream unit operations which include Protein affinity chromatography (PAC), Low pH treatment (LPT), Anion Exchange Chromatography (AIEX) and Nanofiltration (NF).• Planning and execution of freeze-thaw (FT) study for process intermediates (PI) and drug substance (DS) to access its stability and impact on quality attributes.C) Documentation• Authoring the tech transfer documents such as PIN, BMR, TTD, IPQC Specs etc.• Data collation, interpretation, presentation & authoring of developmental protocols and reports of different studies like hold time, freeze-thaw studies etc.D) Other Activities• Core team member for organizing scientific interaction and Fun activities in R & D.

Ahmedabad Area, India

• Execution of comprehensive Biosimilarity studies for multiple biotherapeutics which includes mammalian and microbial-based protein therapeutics.• Analytical method development of monoclonal antibody (Mabs) and antibody fragments. • Analytical method development for antibody fragments such as RP-HPLC, CEX-HPLC, and HIC-HPLC.• Universal platform method development of peptide mapping development for monoclonal antibody (Mabs) molecules. • Analytical platform method development of CEX-HPLC techniques for multiple monoclonal antibodies (Mabs) in the target isoelectric point of 7.50 to 8.90.• Investigation of process and product-related impurities to support the downstream process developmental activities.• Tech transfer of analytical methods to the Quality control (QC) department..