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BioKey Inc.

Fremont, CA, US

BioKey, Inc. is a contract development and manufacturing organization providing a wide range of services; including, API characterization, pre-formulation studies, formulation development, analytical method development, stability studies, IND/NDA/ANDA/510K submissions, and manufacturing clinical trial materials (phase 1 through phase 3) and commercial manufacturing.

The advantages of working with BioKey are:

  • A pharmaceutical experienced management team
  • Possession of platform technologies
  • Wet granulation, Tray drying
  • A cGMP facility with space for future expansion, and
  • Our total commitment to quality, timely and flexible services.

BioKey Inc. has not listed any services.

HPLC Method Development
Price on request

Our Senior Chemists are experienced developers of HPLC analytical assay methods with various columns (reversed phase, ion chromatography, and size exclusion) with UV and reflective index detectors for pharmaceutical compounds with or without chromophores.

Our Senior Chemists are experienced developers of HPLC analytical assay methods with various columns (reversed phase, ion chromatography, and size exclusion) with UV and reflective index detectors for pharmaceutical compounds with or without chromophores.

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Forced Degradation Studies
Price on request

Conduct stressed sample degradation studies to determine potential degradants and impurity profiles. Identification using diode array analysis of peak purity to develop a stability indicating chromatographic method.

Conduct stressed sample degradation studies to determine potential degradants and impurity profiles. Identification using diode array analysis of peak purity to develop a stability indicating chromatographic method.

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Dissolution Testing
Price on request

Develop and perform dissolution profile studies for immediate release and extended release finished products (tablets and capsules) in various media and pH buffer solutions such as SIF, SGF, acetate. BioKey, Inc. is expert in the development of media with various surfactants for pharmaceutical products insoluble in water.

Develop and perform dissolution profile studies for immediate release and extended release finished products (tablets and capsules) in various media and pH buffer solutions such as SIF, SGF, acetate. BioKey, Inc. is expert in the development of media with various surfactants for pharmaceutical products insoluble in water.

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Regulatory Affairs Services
Price on request

BioKey, Inc. provides a variety of regulatory services tailored to your needs. Customers receive prompt, knowledgeable assistance on projects of any size. Regulatory support services include proofreading and regulatory review of submission documents related to formulation development, clinical trials, marketed products, generics,... Show more »

BioKey, Inc. provides a variety of regulatory services tailored to your needs. Customers receive prompt, knowledgeable assistance on projects of any size. Regulatory support services include proofreading and regulatory review of submission documents related to formulation development, clinical trials, marketed products, generics, nutraceuticals and OTC products. Training presentations on the topics listed are also available upon request.

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Cleaning Validation Services
Price on request

Develop and validate very sensitive methods for swab samples and HPLC, or rinse samples and Total Organic Carbon (TOC) to verify the cleaning of pharmaceutical equipment.

Develop and validate very sensitive methods for swab samples and HPLC, or rinse samples and Total Organic Carbon (TOC) to verify the cleaning of pharmaceutical equipment.

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Raw Material Testing
Price on request

Perform identification of incoming materials (API, excipients, and raw materials) using FT-IR.
Conduct basic physical/chemical testing according to USP methods such as pH, turbidity, density, solubility profile over pH range, melting point, loss on drying, loss on ignition, viscosity and conductivity testing.

Perform identification of incoming materials (API, excipients, and raw materials) using FT-IR.
Conduct basic physical/chemical testing according to USP methods such as pH, turbidity, density, solubility profile over pH range, melting point, loss on drying, loss on ignition, viscosity and conductivity testing.

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Product Formulation Development
Price on request

At BioKey Inc. scientific technology and experience are blended together with efficiency, flexibility and creativity. BioKey provides services for formulation and process development.

Our formulation and process development services are orientated to the needs of our clients in a time-efficient and cost-saving manner. Our... Show more »

At BioKey Inc. scientific technology and experience are blended together with efficiency, flexibility and creativity. BioKey provides services for formulation and process development.

Our formulation and process development services are orientated to the needs of our clients in a time-efficient and cost-saving manner. Our formulation and process teams apply their extensive scientific knowledge and experience to achieve the goal of our clients. BioKey supports our clients with pride at all stages of development -- from sketches to ANDA, IND, and NDA filings.

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Process and Scale-Up Chemistry
Price on request

We have integrated process development in our product development program so that each ingredient contributes to product performance and required attributes. We optimize our clients' products, formulations and processes using flexible scientific approaches, such as Design of Experiments (DOE) and Quality by Design... Show more »

We have integrated process development in our product development program so that each ingredient contributes to product performance and required attributes. We optimize our clients' products, formulations and processes using flexible scientific approaches, such as Design of Experiments (DOE) and Quality by Design (QbD).

BioKey has highly trained scientists and operators, as well as a broad array of R&D, scale up and manufacturing equipment to meet our clients' project requirements.

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Analytical Chemistry Services
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Project Management & Consulting Services
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Ion Exchange Chromatography
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Lyophilization
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Solid Dosage Formulation
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Refractory Testing
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Chromatography
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Material Characterization Services
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Experimental Design
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Experiment Outsourcing
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Purification Services
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Liquid Chromatography
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Product Development & Testing
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Chemistry and Materials
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Synthetic Chemistry
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Formulation & Manufacturing
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