Process Manufacturing
Resume:
GOPAL DASARI
**** ********* **, ********, ** ****6
********@*****.***
SUMMARY
Biopharmaceutical professional with > 20 years of industrial experience in the management of manufacturing and
technical projects leading to successful completion involving process development, technology transfer, manufacturing
and quality technical support, process validation, and process engineering. Demonstrated experience in successful
execution of major projects related to downstream processing (recovery and protein purification), formulation and
process development, process scale-up, technology transfer, pilot plant manufacturing of drug substance and drug
product for clinical supplies. Extensive expertise in process unit operations and equipment related to compounding,
mixing, sterile filtration, aseptic filling and freeze-drying operations. Subject matter expert in formulation process
development, unit operations, lyophilization, aseptic processing, and fill/finish operations. Management and special
strengths include in the following areas:
• CMO Management for Drug Product
• Manufacturing and Quality Technical Support in
Manufacturing
Formulation, Aseptic Processing and Fill/Finish
Operations for Lyophilized Products • Project Planning and Management
Process Optimization and Process
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Formulation and Process Development of Biologics
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Improvements
Scale-up of Processes from Lab Scale to
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Regulatory Interactions (FDA and EMA)
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Manufacturing Scale
CMC Documentation for Regulatory
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Technology Transfer of Drug Product Manufacturing
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Submissions
Process Validation and Cleaning Validation Change Control
• •
Process Investigations and Implementation of Continuous Improvement using Six Sigma
• •
Corrective Actions (CAPA) and Lean Manufacturing
Proven Written and Oral Communication Skills, and
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Budget Development and Management
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Interpersonal and Mentoring skills
Professional Experience
8/12 – 12/13: Principal Consultant, Drug Product Process Development (Global Bioprocess Consultants,
Inc.) at Amgen, Seattle, WA
Drug Product Process Development of Amgen’s Biosimilar molecules:
• Successfully developed robust lyophilization process for one product to generate different
doses of drug product using DOE and Design Space approaches. Successfully scaled up
the developed processes from laboratory scale to clinical scale.
• Performed physical and thermal characterization (FDM and DSC) of drug substance to
evaluate critical process parameters (Tc and Tg’) in the design of lyophilization cycles to
obtain optimal drug product attributes.
• Developed and optimized process unit operations related to DS freeze/thaw, bulk mixing,
sterile filtration, aseptic filling and finishing of drug product.
• Executed laboratory, pilot and clinical scale lyophilization cycles to achieve stable, low
moisture and elegant looking drug product cake.
• Led a cross-functional team in to develop target analytical methods. Planned and
conducted accelerated and long term stability studies on drug product to establish the
target process parameters.
• Facilitated the technical transfer of DP process from CMO to Amgen clinical manufacturing
facility - actively reviewed the gaps and risk assessments of various drug development
parameters and recommended productive changes in the drug product process
development.
8/07 – 8/12: Sr. Manager, BD Process Sciences, Bioformulation Development, Allergan, CA
Led formulation and process development, lyophilization cycle development, process
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optimization and scale-up projects, process robustness studies, process parameter
G. Dasari
specifications development, contain closure development, process characterization, and
technical transfer to pilot plant and manufacturing-scale.
Managed manufacturing and technical support for drug product manufacturing (Botox).
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Led process discrepancy and OOS investigations, and resolved process issues for product
release and implemented corrective actions to reduce process variation. Supported CMC
documentation for regulatory submissions.
Led a team to develop room temperature stable lyophilized non-protein (NP) formulations
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for two recombinant molecules. Successfully performed technology transfer of lab scale to
pilot scale process for two molecules.
Managed pilot plant operations successfully to manufacture and supply lyophilized drug
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products for stability studies, toxicology and clinical studies (Phase 2). Leading a
technology transfer of pegylated recombinant protein molecule for ophthalmic applications
from Phase 2 to Phase 3. Successfully managed > $2M budget within 3% variance
1/07 – 7/07: Bioprocess Consultant – Drug Product Process Engineering, Genentech, CA
Successfully executed Process engineering projects related to drug product process
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equipment, small parts cleaning equipment, container closure, and technical support for
aseptic filling and finishing operations.
Performed technical evaluation of automated visual testing equipment drug product vials
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and evaluation of terminal sterilization requirements for aseptically filled liquid product in
prefilled syringes.
12/05 – 12/06: Associate Director, Process Development – Pharmaceutical Development, Discovery
Laboratories, Mountain View, CA
Led a process development team and successfully developed of process for lyophilized
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product with lung surfactant containing a synthetic peptide (KL4) using development scale
lyophilizers. Performed robustness studies and developed process parameter
specifications and product specifications. Product stability studies were performed for
lyophilized product using ICH guidelines.
Successfully managed and negotiated the purchase of commercial scale and development
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scale lyophilizers with significant savings.
Led a team on technology transfer to manufacturing scale, drug product process validation
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and manufacturing support.
Evaluated the suitability of lyophilized product sterilization using gamma-irradiation method
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in a contract lab. Managed a team of four scientists and process engineers.
11/04 – 11/05: Bioprocess Consultant – Process Development, Discovery Labs and Tercica, Inc., CA
Discovery Labs: Successfully executed projects related to lyophilization cycle
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development, trouble shooting of freeze-dryers, selection of container closure system, lung
surfactant product stability, terminal sterilization of product by gamma irradiation, and lung
surfactant aerosol delivery devise for neonatal babies.
Tercica, Inc: Successfully completed projects on CMC project support for regulatory
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submission, process development, technology transfer, and process validation related to
clinical manufacturing of rhIGF-1 (Increlex) (@ Cambrex BioSciences (Lonza), MD). The
technical projects were related to WCB (E. coli) qualification, process development and
manufacturing scale technology transfer studies (fermentation, recovery and purification),
optimization of protein refolding and column dynamic capacity studies.
6/03 – 10/04: Principal Process Development Scientist – Process and Technology Development, Bayer
Healthcare Corporation, Berkeley, CA
Managed a team on process development and manufacturing technical support projects
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related to downstream processing operations (purification, fill and finish) of rFVIII
(Kogenate), Antithrombin III (Human), α-1Antitrypsin (Human) and Human Serum Albumin.
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G. Dasari
Successfully managed manufacturing process investigations and resolved process related
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discrepancy issues for product release. Implemented CAPA process through corrective
actions to improve process performance and process robustness. Reviewed process data
trend charts for excursions and yields on biweekly basis. Significant contributions were
made for establishing root cause analysis through FMEA for failed lots of drug substance
and drug product.
Managed a pilot plant to purify rFVIII from new cell lines and protein free media for
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characterization and stability studies.
Successfully completed UF/DF feasibility and PD studies with TFF system scaled up to
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large scale unit. Completed resin life-cycle validation studies for chromatographic columns
using scale-down models.
Led a team on process development studies and manufacturing-scale process
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performance qualification validation studies for filtration, chromatographic columns, and
UF/DF.
Led a team on the optimization of drug product process unit operations and freeze drying
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cycle for three commercial products.
12/00 – 5/03: Research Scientist - Technical Operations, Baxter Healthcare Corporation, CA
Successfully managed projects related to manufacturing and technical support of fill-finish
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operations of Recombinate (rFVIII), process equipment support for Isolator and New
Lyophilizers, process validation, and cleaning validation.
Led projects on yield and process improvements in formulation and filling. Successfully
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implemented yield improvement projects in formulation unit operations of Recombinate and
increased the yields which generated an additional amount of drug product >$100M per
year. Received Baxter’s Distinguished Contribution Award in 2003.
Successfully managed manufacturing process investigations and resolved process related
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discrepancy issues for product release. Implemented CAPA process through corrective
actions to improve process performance. Reviewed process data trend charts for
excursions and yields on a regular basis.
Developed a new and optimized lyophilization cycle in a pilot scale freeze-dryer for rFVIII
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formulations and implemented new lyophilization cycle in the manufacturing scale freeze-
dryers.
Led a team to change of vials from molded (Wheaton) to tubular vials (Schott) for rAHF
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and successfully completed the project ahead of timeline commitments.
Provided technical support for automated vacuum testing and implementation isolators,
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automated filling and loading systems, validation of new lyophilizers.
Led a team on technology transfer of rAHF-PFM (Advate) for formulation and finishing from
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Vienna, Austria to Thousand Oaks, CA.
7/97 – 11/00: Manager - Technical Services, Baxter Healthcare Corporation, Los Angeles, CA
Managed manufacturing and technical support of purification and fill-finish operations of
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three commercial products [AHF-M (FVIII), Autoplex (FII and FVII), Proplex (FIX)] and
Plasma Teardown and projects related to process improvements, technology transfer,
process validation and cleaning validation.
Led a team to successfully perform process investigations and resolved process
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discrepancy and deviation issues for product release and implemented corrective actions.
Many commercial lots were released with > $25M savings for the company.
Successfully completed process qualification and validation projects related to AHF-M lot
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size reduction related to American Red Cross.
Managed nano-filtration project including lab-scale development and scale-up studies on
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viral reduction for AHF-M.
Led a team to optimize the lyophilization cycle for AHF-M product line and implemented at
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manufacturing scale to reduce the overall cycle time.
Project leader for process validation and plant wide cleaning validation projects.
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Successfully completed process validation of three products and plant-wide cleaning
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G. Dasari
validation ahead of project timeline commitments. Managed all the project activities and
consultants. Managed a budget of >$15M on process validation and cleaning validation
projects.
Managed process improvement project including life cycle validation of chromatographic
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resins using scale-down models, evaluation of antimicrobial efficacy of various storage
solutions for MAb resin and validation of the MAb column cleaning and regeneration
procedures, mixing time validation of solvent/detergent addition in AHF-M, sterile bulk hold
time validation for three products in CPM and reduction of process cycle time by 20% for
AHF-M.
Provided project support for technology transfer of IgG process from Los Angeles plant to
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Rochester plant in MI.
10/96 – 6/97: Group Leader (Scientist), Applied Phytologics, Inc., Sacramento, CA
Optimized plant cell suspension cultures from lab to pilot scale. Developed optimal
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conditions for expression of human α-1-antitrypsin in suspension cultures. Developed
downstream processing steps for recovery and purification of α-1-antitrypsin.
3/96 – 9/96: Researcher-V, Dept. of Bio. and Ag. Eng, University of California, Davis, CA
Performed research work on the application of Biosensors (enzyme based) to determine
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the quality and shelf-life of temperature sensitive biomaterials and perishable foods.
4/92 – 10/95: Biochemical Engineer, Bio-Consultants, Victoria, Australia
Performed process development and optimization work on the purification of Antithrombin
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III from human plasma using column chromatography (Ion exchange and affinity),
ultrafiltration and diafiltration) for CSL Ltd.
Designed and setup a pilot-scale bioreactor facility for mammalian cell culture for human
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growth hormone production.
4/89 – 3/92: Research Engineer, Centre for Bioprocess Technology, Monash University, Victoria, Australia
Performed research, process development, optimization and scale-up work on the
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separation and purification of bFGF from bovine amniotic fluid, and thrombin from human
plasma using packed and fluidized bed chromatographic systems in collaboration with CSL
Ltd. Performed research work on the propagation and growth kinetics of CHO cells in lab-
scale bioreactors.
8/82 - 3/89: Research Associate, Chemical Engineering Dept, University of Melbourne, Australia
Performed research on the effect of oxygen and nutrients on growth kinetics in yeast and
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bacterial fermentations. Studied the effect of product and by-product inhibition on growth
kinetics in yeast fermentations. Carried out experimental work with different nutrient
feeding strategies for high cell density fermentations.
9/81 – 7/82: Biochemical Engineer, Indian Institute of Technology, New Delhi, India.
Performed scale-up of fermentation processes from lab to pilot-scale (up to 150L), for the
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production and recovery of cellulase enzyme.
EDUCATION:
M.S. Biochemical Engineering, Indian Institute of Technology, 1981, New Delhi, India
B.S. Chemical Engineering, National Institute of Technology, 1979, Warangal, India
MEMBERSHIPS:
Member of ISPE, AAPS, American Institute of Chemical Engineers and PDA
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G. Dasari
AWARDS AND PATENTS:
Allergan’s Award of Excellence in 2012: For technology transfer and management of CMO for drug
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product manufacturing.
Patent: Clostridial toxin pharmaceutical compositions: Animal protein-free, solid form Clostridial toxin
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pharmaceutical compositions comprising a Clostridial toxin active ingredient and at least two excipients, US
2009/067538 and WO2010/090677 A1.
Baxter’s Distinguished Contribution Award in 2003: Formulation process yield improvement project for
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Recombinate (rFVIII) which generated additional revenue more than $100M per year.
PUBLICATIONS:
Sun, C. S., Zhang, L., Ortiz, R., Gass, J., Mengelt, T., Dasari, G. and Szeto, S., Evaluation of the Antimicrobial Efficacy of
Various Solutions for Storing MAb Gel Used in Hyland Immuno Method M (AHF-M) Process, Baxter 9th Science and
Technology Seminars, Poster # 403-D, May 20-23, 2001, Chicago, IL.
Dasari, G. and Paul Singh, R., Use of Time-Temperature Indicators in Transport and Storage of Orange Juice, IFT Annual
Meeting, 59D-23, June 14-18, 1997, Orlando, Florida.
Dasari, G., Prince, I. and Hearn, M. T. W., Investigations into the Rheological Characteristics of Bovine Amniotic Fluid, J.
Biochem. Biophys. Methods, 30, 217-225, 1995.
Hobley, T. J., Stanley, G. A., Dasari, G. and Pamment, N. B., Significance of Rate of Cellular adaptation to Ethanol and
Rate of Change of Ethanol Concentration in Fermentations by Zymomonas mobilis and Yeast, 6th European Congress on
Biotechnology, June 13-17, 1993, Florence, Italy.
Dasari, G., Prince, I. and Hearn, M. T. W., Physical Characterisation of Fluidized Bed Behaviour of Chromatographic
Packing Materials, J. Chromatogr., 631, 115-124, 1993.
Dasari, G., Finette, G., Prince, I. and Hearn, M. T. W., Protein Purification using Fluidized-bed Chromatography, 10th Aus-
tralian Biotechnology Conference, 312-315, February 4-7, 1992, Melbourne.
Pamment, N. B. and Dasari, G., Ethanol Inhibition in Yeast Fermentations: The Significance of the Rate of Change of
Ethanol Concentration and Magnesium Deficiencies, 5th European Congress on Biotechnology, July 8-13, 1990,
Copenhagen, Denmark.
Pamment, N. B., Dasari, G. and Worth, M. A., Mechanisms of Ethanol Inhibition in Yeasts, International Biotechnology
Conference on Fermentation Technologies: Industrial Applications, 241-246, February 12-15, 1990, Palmerston North, New
Zealand.
Dasari, G., Worth, M. A., Connor M. A. and Pamment, N. B., Reasons for the Apparent Difference in the Effects of
Produced and Added Ethanol on Culture Viability During Rapid Fermentations, Biotechnol. Bioeng., 35, 109-122, 1990.
Pamment, N. B. and Dasari, G., Intracellular Ethanol Concentrations and Its Estimation, In: Alcohol Toxicity in Yeasts and
Bacteria, van Uden, N., (Ed.), Ch-6, 147-192, CRC Press, Inc., Baca Raton, Florida, 1989.
Worth, M. A., Dasari, G., Connor M. A. and Pamment, N. B., Reasons for the Apparent Difference in the Inhibitory Effects of
Produced and Added Ethanol in Saccharomyces Fermentations, VIII International Biotechnology Symposium, B-83, 1988,
Paris, France.
Dasari, G., Worth, M. A. and Pamment, N. B., Why is Ethanol Produced by Yeasts During Fermentation Apparently more
Toxic than Added Ethanol, ASM Annual Scientific Meeting, Canberra, May 9-13, Published in Aust. Microbiologist, 9, 199,
1988.
Pamment, N. B., Dasari, G. and Worth, M. A., Influence of Nutrient Deficiencies and Inhibition by Substrate and By-
Products on the Apparent Difference in Toxicity of Produced and Added Ethanol in Yeast Fermentations, VII International
Symposium on Yeasts, P-29, 1988, Perugia, Italy.
Dasari, G., Connor, M. A. and Pamment, N. B., Comparative Toxicity of Produced and Added Ethanol in Yeast
Fermentations, 7th Australian Biotechnology Conference, 420-424, August 25-28, 1986, Melbourne.
Dasari, G., Keshavarz, E., Connor, M. A. and Pamment, N. B., Intracellular Ethanol Concentrations and Comparative
Toxicity of Endogenously Produced and Added Ethanol in Saccharomyces Fermentations, XI International Specialised
Symposium on Yeasts, L-23, March 1986, Lisboa, Portugal.
Dasari, G., Keshavarz, E., Connor, M. A. and Pamment, N. B., A Reliable Method for Detecting the Intracellular Accumula-
tion of Fermentation Products: Application to Intracellular Ethanol Analysis, Biotechnol. Lett., 7, 541-546, 1985.
Pamment, N. B., Dasari, G., Roddick, F. and Connor, M. A., Significance of Intracellular Ethanol in Saccharomyces
cerevisiae Fermentations, VII International Biotechnology Symposium, V-1, 145, 1984, New Delhi, India.
Dasari, G., Roddick, F., Connor, M. A. and Pamment, N. B., Factors Affecting the Estimations of Intracellular Ethanol
Concentrations, Biotechnol. Lett., 5, 715-720, 1983.
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