Anthony Hawrylechko
Senior Director, Bioprocess Development at Codexis, Inc.
Biochemist with 25 years of experience in the Upstream mammalian and bacterial process development, purification development, formulation, scale-up, and cGMP manufacturing of biologics (mAbs, cytokines, enzymes, and chimeric proteins) for pharmaceutical applications. I am a professional who can strategize, provide leadership, foster team excellence, build out labs and services, and get the most challenging jobs done on time and on budget. Proficient with independent experimentation or co-ordination of multidisciplinary internal, contract development and cGMP manufacturing teams. Skilled in planning, budgeting, organizing, and managing project development, transfer, and implementation from feasibility experiments through clinical manufacturing and process validation. Extensive technical experience in the development and troubleshooting of analytical methods, CHO cell lines, fermentation, primary recovery, protein folding, purification development, and process scale up. Supportive and attentive management style that fosters respect, growth and accountability through employee training, supervision, and career guidance.

Specialties: Excels at innovation and complex analyses, including DOE, and resolving issues as the result of scale-up or process transfer, improving protein folding, protein compatibility with contacting materials, in-process biophysical factors, delivery systems for different indications, non-ideal analytical behavior, excipient optimization, and stability issues.
Codexis, Inc.
https://www.linkedin.com/company/codexis
Redwood City, California, United States
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Senior Director, Bioprocess Development
Halozyme Therapeutics, Inc.
https://www.linkedin.com/company/halozyme-therapeutics-inc-
San Diego
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Director of Bioprocess Development
Cytovance Biologics
https://www.linkedin.com/company/cytovance
Oklahoma City, Oklahoma Area
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Director of Mammalian Bioprocess & Protein Expression Technologies
Cytovance Biologics
https://www.linkedin.com/company/cytovance
Oklahoma City, Oklahoma
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Director of Microbial Bioprocess
Cytovance Biologics
https://www.linkedin.com/company/cytovance
Oklahoma City, Oklahoma Area
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Senior Manager, Manufacturing Science and Technology
NeoPharm Inc
https://www.linkedin.com/company/neopharm-inc.
Technical team lead for scalable purification processes transitioning from Phase I to a post Phase III (pre-commercial) therapeutic, chimeric protein derived from E. coli. 
Setup of a purification development and analytical laboratory, supervision, mentoring and training of subordinates, method development, process development, process transfer to contract manufacturers, batch record review, on-site liaison with contract manufacturing (fermentation to folding to fill/finish), cGMP process troubleshooting, evaluation of stability studies (i.e., cell banks and product), and lead technical author of clinical and regulatory documentation and responses to subsequent inquiries. 
Group goal setting, design, coordination and timeline development, and execution of process characterization (i.e., identify and define critical parameter process ranges with qualified scale-down model), product characterization, HPLC and cell-based Bioassay refinement and troubleshooting experiments were performed in preparation for clinical and pre-commercial manufacturing.
Re-formulation product and process development, scale-up, and cGMP manufacturing were performed for a lyophilized, inhaled recombinant protein for pre-clinical & Phase I studies.
Manager, Process Development & Manufacturing
GlaxoSmithKline
https://www.linkedin.com/company/glaxosmithkline
Involved in development of scalable, robust processes for pre-clinical and clinical manufacturing of murine (for pre-clinical model) and human therapeutic proteins derived from E. coli. Performed various scales (AKTAexplorer 100, BioProcess skid) of purification techniques (lysis, precipitation, continuous centrifugation, filtration, chromatography, aseptic fill) to characterize and remove of host and product-related impurities throughout the varied stages of purification. Supplied and managed the inventory of pre-clinical material. Explored the purification of pegylated forms of a clinical human protein therapeutic.
Used statistical experimental design to optimize and prove the scalability and commercial feasibility of expanded bed chromatography capture of product from E. coli lysate compared to a standard process.
◊Coordinated a departmental Seminar series and supervised personnel.
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Associate Investigator
Biomira, Inc
Refined a scalable downstream process for a recombinant protein derived from an E. coli. This involved research, project planning, documentation development (Protocols, SOPs, Batch Records) employee supervision, co-ordination of development teams and independent research to improve the extraction, folding, in-process assays, and downstream isolation of a human cytokine for in vivo therapeutic use.
Responsible for the cost-effective design, development, and scale-up of a unique process to generate a mAb fragment (i.e., in vivo diagnostic) for a contract client. Generated a development plan that included project management of feasibility studies, assay & process development, scale-up, documentation (Batch records, etc.), and man-in-plant observation of successful Phase I contract manufacturing.
Experienced in the development and process characterization of mAb purification processes and process support for clinical manufacturing. This included personnel training, process validation design, experimentation, large-scale purification of mAb, small-scale evaluation of process limits, impurity characterization and troubleshooting of large scale purification “anomalies”.
Process Development Associate
MSc
Biochemistry
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Queen's University
https://www.linkedin.com/school/queen's-university/
BSc.
Microbiology
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University of Alberta
https://www.linkedin.com/school/university-of-alberta/
Protein folding by dilution is a common approach used in the manufacturing of biologics derived from microbial expression systems. This typically involves the solubilization of a washed inclusion body preparation containing the concentrated product polypeptide with a strong chaotrope or detergent solution. The denatured, inactive product solution is then diluted into a combination pH and red/ox buffer solution. Within this environment, the molecular diffusion rates of chaotrope, buffer components, and water are hundreds of times greater than that of a typical denatured polypeptide, requiring convective mixing to separate the refolding polypeptide chains to favor the formation of the properly folded, active, monomeric product. A discussion of the details of the timeline of protein folding and the importance of mixing dynamics and appropriate optimization is provided.

Certain types of large-scale impeller-based mixing systems generate very high shear forces at the tips of the impeller blades that may perturb the delicate structures of polypeptide chain in the process of folding into an active structure. However, these intense forces rapidly decrease to laminar, non-convective mixing conditions with increasing distance. As a result, large scale impeller mixing vessels often require significant time to reach a homogenous solution state. Given that the secondary structure formation of a folding polypeptide is around 10 microseconds, the mixing characteristics of some impeller based vessels are less optimal and tend to favor the aggregation of the polypeptides and product loss.

The imPULSE technology is scalable from 30 L up to 5000 L and allows for robust control of process temperature, mixing, in-process monitoring, along with single use technology to result in an efficient development and manufacturing platform to establish a robust control strategy for protein folding of biologics.
Improving Protein Folding Control and Scalability Using imPULSE Mixing Technology
Bioprocess International
http://www.bioprocessintl.com/ask-the-experts/improving-protein-folding-control-scalability-using-impulse-mixing-technology-2/
LinkedIn
www.linkedin.com
What to Do in the First 90 Days of Your New Job
https://www.linkedin.com/learning/what-to-do-in-the-first-90-days-of-your-new-job
LinkedIn
www.linkedin.com
Lean Six Sigma: Define and Measure Tools
http://www.linkedin.com/learning/lean-six-sigma-define-and-measure-tools
https://www.linkedin.com/in/homa-yeganegi-254b575
San Francisco, CA
Homa Yeganegi
Global Program Lead and Senior VP Global Medical Affairs at Turning Point Therapeutics, Inc.
https://is.linkedin.com/in/chandranath-ganapathy-67a1288
Reykjavík
Chandranath Ganapathy
Director of Downstream Process Development at Alvotech
https://www.linkedin.com/in/gloria-lam
San Diego, CA
Gloria Lam
Regulatory Affairs Specialist at Halozyme Therapeutics, Inc.
https://www.linkedin.com/in/donald-wuchterl-b228625
San Francisco Bay Area
Donald Wuchterl
Senior Vice President and Chief Manufacturing Officer at T-knife
https://www.linkedin.com/in/-dianagutierrez
United States
Diana Wappel
Manufacturing Technician IV at FUJIFILM Diosynth Biotechnologies
https://www.linkedin.com/in/patriciaryan
San Diego, CA
Patricia Ryan, PhD
VP, Regulatory Affairs at Kartos Therapeutics, Inc.
https://www.linkedin.com/in/jason-dugan-b9b385120
San Antonio, TX
Jason Dugan
Manufacturing Sciences and Technology Scientist at Cytovance Biologics
https://www.linkedin.com/in/brent-van-rite-97a0a4b
Oklahoma City Metropolitan Area
Brent Van Rite
Biologics Manufacturing
https://www.linkedin.com/in/christa-short-a5279515a
Norman, OK
Christa Short
VP of Process Sciences at Wheeler Bio
https://www.linkedin.com/in/christina-pennington-73a38b128
San Diego, CA
Christina Pennington
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https://www.linkedin.com/in/richie-thao-550079123
Oklahoma City, OK
Richie Thao
Downstream Manufacturing Associate II at Cytovance Biologics
https://www.linkedin.com/in/johncuello
Greater Philadelphia
John Cuello, M.S., (Army Retired)
Talent Acquisition, Biologics -Global Product Development & Supply at Bristol Myers Squibb
https://www.linkedin.com/in/ken-schultz-6616711
Los Angeles Metropolitan Area
Ken Schultz
Medical Doctor│McKinsey Consultant│CEO│Business Development│Strategy│Pharmaceuticals│Biotechnology│Drug Development
https://www.linkedin.com/in/john-warner-5681177
Wilmington, MA
John Warner
Reimagining how we TEACH, DO, INVENT and MANAGE Chemistry.
https://www.linkedin.com/in/mike-paolucci-ab900413
San Diego, CA
Mike Paolucci
Human Resources Executive and BOD Member
https://ae.linkedin.com/in/karthikeyan-kesavalu-a41535139
Ras al Khaimah, United Arab Emirates
Karthikeyan Kesavalu
Junior Specialist - Quality Control
https://uk.linkedin.com/in/matthew-cadwallen-047a34b9
London
Matthew Cadwallen
Consultant at Euromedica
https://at.linkedin.com/in/martin-zeiner-58196b81
Innsbruck
Martin Zeiner
Key-Account-Manager bei Innerspace - The Simulator Company
https://www.linkedin.com/in/anthony-hawrylechko-69a688ba
United States
Anthony Hawrylechko
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Quality-by-Design (QbD) and PAT
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Fermentation & Process development
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Biosimilars
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Pharmaceutical Manufacturing Science, Quality and Regulation
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The Biopharmaceutical CMC Group
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Pharma Manufacturing, Putman Media
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Protein Biochemistry and Biophysics
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