Premnath S., Ph.D. Email & Phone Number

Hyderabad, Telangana, India

Purification of Viral Vectors & Antibodies

Ahmedabad, Gujarat, India

Ahmedabad Area, India

Downstream process development of gene therapy product.

Chennai Area, India

 Purification process development of biosimilar MAbs• Lead of UFDF process development for IgG1 including process optimization, scale up & tech transfer to manufacturing sites.• Lead of affinity chromatography development for IgG2 which includes process optimization.• Experience on various process optimization of DSP unit operation (AEX, AFC, clarification & UFDF) & process lock.• Scale up of purification process to pilot facility including preparation of tech transfer document to enable process lock for biosimilars.• Experience on pegylation of biotherapeutic proteins.• Compilation and interpretation of data and presentation on different forums.• Coordinated cross functional meeting (Eg. DSP-Pilot meeting enabling process lock)• Well versed in writing technical protocols and reports.• Familiarize with electronic lab notebook and statistical tools such as JMP. Tech domain lead for continuous chromatography and TFF• Experimental design and evaluation of continuous chromatography (Akta PCC) • Evaluation and recommendation of lab scale low holdup TFF system.• Mentored team members on UF/DF and Akta PCC continuous chromatography process. Lab management activities• Lead compliance related activities for DSP includes monthly internal audit observation and closure.• Coordinated and conducted weekly lab meeting includes preparation of minutes of meeting.• Functional SPA for GDMS, share point management system.

New Delhi Area, India

• Separation and transmission of ovalbumin and lysozyme in dead end and cross flow UF module.• Purification and flux decline of haemoglobin and ovalbumin in dead end and cross flow UF module.• Method development for protein separation in Size exclusion and Reverse phase- HPLC columns.• Managed bioprocess design and downstream processing lab courses for undergraduate students.

 Exposure to large scale purification techniques. Training on fire safety precautionary measures in work place and knowledge on gowning protocols.

 PEGylation and purification process improvement of recombinant therapeutic proteins. Involved in purification process characterization activities as a part of regulatory requirements.• Exposure to scale down model qualification required for process characterization.• Ranging studies of purification process step for recombinant proteins.• Hold time studies for in-process step outputs in purification process.

Industrial training on "Biopharma production and bioprocess engineering" which includes Fermentation, Cell culture, DSP and validation of sterilization and filtration process.* Medium Optimization & kLa estimation for fermentation process * Growth studies, contamination studies & serum studies of BHK 21 cells* Hands on with various chromatographic techniques and TFF process.* ESIP, FSIP & CIP validation; Filter validation; IQ, OQ & PQ of autoclave & DHS

Doctor Of Philosophy - Phd, Biochemical Engineering

Comparative study of protein fractionation in stirred cell and cross flow ultrafiltration modules

M.Tech, Industrial Biotechnology

Project title:Fermentation study on xanthan gum production

B.Tech - Industrial Biotechnology