GXP BIOPHARMA, LLC.

GXP BIOPHARMA, LLC is a privately held Biopharma Contract Development Manufacturing Organization (CDMO) company for producing new Biopharma Products for Clinical Trials by its clients. GXP BIOPHARMA will service universities, Incubator Companies, and small and large Biotechnology industry developing Biopharma products for health care. GXP-BIOPHARMA production includes Research, Diagnostic, Therapeutic and Combination Drug-Device products.

GXP-BIOPHARMA can provide Regulatory Submissions (IND, Investigational New Drug Submissions) for Clinical Trials.

GXP-BIOPHARMA can provide start up Biopharma companies with GMP Incubator Laboratory space.

Commercial Manufacturing will be performed by GXP BIOPHARMA corporate collaborators.

SERVICES

GXP BIOPHARMA is focused on products of the future for the treatment of cancer, heart disease, Alzheimer’s, etc.

BIOCULTURE

Cell Banks, Cell and Microbial Bioreactor GMP Production. Eukaryotic and Prokaryotic. Stem Cell and Gene Therapy. Animal, Plant, Microbial cell culture using Bioreactors up to 500 Liters using Stainless Steel and Single Use Bioreactors.

PURIFICATION

Protein and Antibody Drug Conjugation.Tangential flow filtration (TFF) for Bioculture cell removal and supernatant concentration and buffer exchange for Chromatography. Chromatography Affinity, Ion Exchange, Size Exclusion using Glass and Single Use Chromatography Columns.

PRESENTATION

Aseptic Filling of Biopharma product in Vials, Syringes, Ampules, Cartridges, Combination Drug Device or custom up to 2,000 a day. Required Biopharma product GMP Testing. Required Biopharma product Stability Studies. Required Biopharma product storage and Distribution to Clinical Sites.

THE GXP BIOPHARMA TEAM

ASHOT PETROSSIAN, Ph.D.

PRINCIPAL MANAGER

Dr. Ashot Petrossian is the Principal Manager of GXP-BIOPHARMA. Ashot is a graduate of Cornell University in Biochemistry and University of California at Berkeley with PhD in Biophysics degrees with a thesis on monoclonal antibodies. Ashot has 40 years of experience in Therapeutic Biotechnology Operations, Bioreactor Technology, and Biopharma Facility Conceptualization, Construction and Compliance. Ashot has 40 years of experience in Biopharma Process, Production, Compliance and Validation and Facilities. Ashot has worked at Porton International, InVitron (Monsanto),Techniclone (AVID Bioservices), Xoma, Kokak (Sterling Drug), Washington Group (Raytheon) and founder of GXP CONSULTANTS ALLIANCE INC and GXP BIOPHARMA LLC.

EDWARD YAGHOUBIAN, Ph.D.

PRINCIPAL QUALITY

Dr. Edward Yaghoubian is Principal Quality of GXP BIOPHARMA. Edward is a graduate of LSU with PhD in Food Science with emphasis on Fermentation with a thesis on Food Fermentation. Edward has 40 years of experience in research, production and quality control of nutritional supplements and food flavors. Edward has worked at NutraSweet, Universal Flavors, General Nutrition Corporation, and has been Director of Research of Centers of Excellence of National Dairy Board at six major universities.

MATTHEW ATWONG, P.E.

PRINCIPAL FACILITIES AND ENGINEERING

Mr. Matthew Atwong, P.E. is the Principal Facilities and Engineering of GXP-BIOPHARMA. Matthew is a Registered Professional Engineer. Matthew is a graduate of the University of Michigan and Grand Valley State University with MSE and MBA degrees. Matthew has 30 years of experience in design, construction and operation of pharmaceutical, medical device, and biotech industries. Matthew has worked at B.Braun, Baxter, Watson, City of Hope, Teva and FujiFilm.

DENIS KLUBA, B.S.

PRINCIPAL COMPLIANCE

Mr. Denis Kluba is Principal Compliance of GXP-BIOPHARMA. Denis is a graduate of University of Missouri-Rolla with BS degree in Engineering Management and a Professional Development Degree in Engineering Management. Denis has 35 years of experience in Biopharma Facility Construction and Commissioning, Compliance and Validation in USA, Europe and CHINA. Denis has worked at Genzyme, Quantic, Sandoz, Invitron (Monsanto), The Alliance Pharm US.

SABOO AGHABABAYAN, M.S., M.B.A.

PRINCIPAL VALIDATION

Mr. Saboo Aghababayan is Principal Validation of GXP-BIOPHARMA.
Saboo is a graduate of Leeds University, England with MS degree in Integrated Design of Chemical Plants, and MBA degree from Worcester Polytechnic Institute (WPI). Saboo has over 30 years of commissioning/qualification/validation experience in corporate, manufacturing, and consulting organizations and is a SME in GMP design/validation of facilities, utilities, equipment, systems, and processes as well as environmental qualification using risk-based approach. Saboo has worked at AstraZeneca, Amgen, Genzyme, and Sanofi as well as Jacobs Engineering, where he has executed multiple assignments at large and small pharmaceutical and biotech companies.