Biopharmaceutical Production
BIOPHARMACEUTICALS PRODUCTION AND TESTING
GXP BIOPHARMA is capable of a full range of production and testing for biomolecules:
From proof of concept to commercialization, GXP BIOPHARMA offers reliable expertise, quality systems, and state-of-the-art instrumentation from our fully cGMP compliant facilities. What's more, we maintain focus on the leading edge of science, service and seamless collaboration. GXP BIOPHARMA provides a range of services such as API manufacturing, cell line development, GMP peptide and protein production, and the development of dosage forms. Our responsiveness and streamlined project management can help leverage your supply chain capabilities and improve project efficiencies that can reduce time to market. At GXP BIOPHARMA our mission is to provide our clients with outsourcing solutions that make their biopharma drug development priorities possible.
ANALYTICAL CHEMISTRY
Our robust capabilities support your projects:
GXP BIOPHARMA is committed to providing expert and timely analytical chemistry support. We offer high quality, affordable compendial testing according to USP/NF, EP, BP, JP, ACS and customer-specified monographs in support of raw materials, in-process analysis, and finished product release testing.
In addition to validation consulting services for device, diagnostics, dietary supplements, drugs, biologics, GXP is unique in providing comprehensive Residual Solvents Testing and Extractable and Leachables Testing for your validation projects.
MICROBIOLOGICAL TESTING AND VALIDATION
We perform a wide array of tests:
GXP BIOPHARMA offers extensive testing services via our highly qualified microbiology team. Our depth of expertise combined with our novel approach to attentive project management and high quality reporting ensure the timeliness your projects demand.
GXP BIOPHARMA offers a broad range of compliant, expert-lead microbiological services. Tests are performed according to official compendial methods such as USP, EP, BP, JP, AAMI, ISO standards and client specific protocols. Validated Class 1000 clean room suites with Class 100 LAF hoods provide the highest quality sterility testing for finished product release.
In addition to validation consulting services for GMP facilities, equipment, cleaning, test methods and process, GXP is unique in providing comprehensive laboratory validation services for facility environmental monitoring, pharmaceutical water testing, pharmaceutical steam testing, pharmaceutical gases testing, analytical method development and validation, cleaning method development and validation and process method development and validation for your validation projects.
PREFORMULATION AND FORMULATION
We support your formulation development:
Preformulation studies are designed with an anticipated formulation strategy, route of administration, and ultimate formulation configuration in mind. Parameters are generated to aid formulation development and/or support preparation of the CMC sections of your IND or BLA. Formulation development begins with a thorough understanding of your needs and consideration of the physico-chemical properties of compounds derived from preformulation studies. As development partners, we will design detailed protocols to help select clinical formulations.
GXP BIOPHARMA'S mission is to provide you with outsourcing solutions that make your drug development priorities possible.
STABILITY TESTING
We support your stability testing projects:
GXP BIOPHARMA offers you state of the art cGMP stability storage facilities with walk in and reach in validated environmental chambers set to various temperatures and humidity conditions, all in accordance with ICH guidelines. Environmental and photostability chambers are monitored 24 hours a day by a computer-based Environmental Monitoring System. Laboratory Information Management System (LIMS) ensures the highest level of compliance and is fully capable of complex trend analysis. The system accommodates sophisticated sample management and allows the Stability Department to generate cumulative reports.
BIOPHARMACEUTICALS PRODUCTION AND TESTING
GXP BIOPHARMA is capable of a full range of production and testing for biomolecules:
From proof of concept to commercialization, GXP BIOPHARMA offers reliable expertise, quality systems, and state-of-the-art instrumentation from our fully cGMP compliant facilities. What's more, we maintain focus on the leading edge of science, service and seamless collaboration. GXP BIOPHARMA provides a range of services such as API manufacturing, cell line development, GMP peptide and protein production, and the development of dosage forms. Our responsiveness and streamlined project management can help leverage your supply chain capabilities and improve project efficiencies that can reduce time to market. At GXP BIOPHARMA our mission is to provide our clients with outsourcing solutions that make their biopharma drug development priorities possible.
ANALYTICAL CHEMISTRY
Our robust capabilities support your projects:
GXP BIOPHARMA is committed to providing expert and timely analytical chemistry support. We offer high quality, affordable compendial testing according to USP/NF, EP, BP, JP, ACS and customer-specified monographs in support of raw materials, in-process analysis, and finished product release testing.
In addition to validation consulting services for device, diagnostics, dietary supplements, drugs, biologics, GXP is unique in providing comprehensive Residual Solvents Testing and Extractable and Leachables Testing for your validation projects.
MICROBIOLOGICAL TESTING AND VALIDATION
We perform a wide array of tests:
GXP BIOPHARMA offers extensive testing services via our highly qualified microbiology team. Our depth of expertise combined with our novel approach to attentive project management and high quality reporting ensure the timeliness your projects demand.
GXP BIOPHARMA offers a broad range of compliant, expert-lead microbiological services. Tests are performed according to official compendial methods such as USP, EP, BP, JP, AAMI, ISO standards and client specific protocols. Validated Class 1000 clean room suites with Class 100 LAF hoods provide the highest quality sterility testing for finished product release.
In addition to validation consulting services for GMP facilities, equipment, cleaning, test methods and process, GXP is unique in providing comprehensive laboratory validation services for facility environmental monitoring, pharmaceutical water testing, pharmaceutical steam testing, pharmaceutical gases testing, analytical method development and validation, cleaning method development and validation and process method development and validation for your validation projects.
PREFORMULATION AND FORMULATION
We support your formulation development:
Preformulation studies are designed with an anticipated formulation strategy, route of administration, and ultimate formulation configuration in mind. Parameters are generated to aid formulation development and/or support preparation of the CMC sections of your IND or BLA. Formulation development begins with a thorough understanding of your needs and consideration of the physico-chemical properties of compounds derived from preformulation studies. As development partners, we will design detailed protocols to help select clinical formulations.
GXP BIOPHARMA'S mission is to provide you with outsourcing solutions that make your drug development priorities possible.
STABILITY TESTING
We support your stability testing projects:
GXP BIOPHARMA offers you state of the art cGMP stability storage facilities with walk in and reach in validated environmental chambers set to various temperatures and humidity conditions, all in accordance with ICH guidelines. Environmental and photostability chambers are monitored 24 hours a day by a computer-based Environmental Monitoring System. Laboratory Information Management System (LIMS) ensures the highest level of compliance and is fully capable of complex trend analysis. The system accommodates sophisticated sample management and allows the Stability Department to generate cumulative reports.
13681 Newport Avenue
Suite 8-620
Tustin, CA 92780
(714) 325-8896
