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BioKey Inc.

Fremont, California, 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.

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ICH Stability Testing
Price on request
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HPLC Method Development
Price on request

We offer various levels of method development to prove the method created is for its intended use.

The rationale usually includes preliminary and confirmation steps:

1) Chemical/Physical Properties Determination:
 pKa value
 log p
 Solubility
 IR spectrum
 UV spectrum

2) HPLC Parameters Determination:
 RP... Show more »

We offer various levels of method development to prove the method created is for its intended use.

The rationale usually includes preliminary and confirmation steps:

1) Chemical/Physical Properties Determination:
 pKa value
 log p
 Solubility
 IR spectrum
 UV spectrum

2) HPLC Parameters Determination:
 RP column stationary phase
 Buffer pH or mobile phase
 Wavelength
 Column particle size/temperature for separation efficiency and selectivity

3) Method Verification to support early phases studies:
 Sample extraction procedures for sample preparation
 Specificity (sample metrices interference)
 Analyte Linearity and Concentration Ranges
 Accuracy

4) Full ICH/USP Compliant Validation for late phase and commercial products
 Specificity (sample metrices interference)
 Analyte Linearity and Concentration Ranges
 Accuracy
 Intermediate precision
 Detection limit/Quantitation limit
 Robustness (slight variation in % organic, pH, flow rate, temperature and wavelength)

For contract Method Development services, we require sponsor to submit at lease 200 mg of the analyte reference standard and its related substance if available. Turnaround time is about two weeks from singing the Work Order and PO received.

Pricing for early phase Method Verification is $8,500 (compendial method). Negotiable if non-compendial method is requested.

The charges for routine measurement do vary by non regulated procedures. The cost can be drastically less if more than one sample is prepared and injected as one batch with sponsor authorization.

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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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Solubility and 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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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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Pharmaceutical Formulation
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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Project and Process Management
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Solid Dosage Formulation
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Experimental Design
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Product Development, Testing, and Packaging
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Formulation Services
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Shelf Life Testing
Price on request

We provide wide range of capabilities in drug substance, Clinical Trial Material, commercial product stability testing and ICH compliant storage services.

Available storage conditions include but not limited to units set at Accelerated, 40C/75%RH, and at Long-Term, 25C/60%RH. All units are protected by uninterrupted powder... Show more »

We provide wide range of capabilities in drug substance, Clinical Trial Material, commercial product stability testing and ICH compliant storage services.

Available storage conditions include but not limited to units set at Accelerated, 40C/75%RH, and at Long-Term, 25C/60%RH. All units are protected by uninterrupted powder supply diesel generator. The performance data of temperature and relative humidity of the chambers are monitored at 24/7.

To accurately detect the changes with time in the pertinent properties of the drug substance and/or product, validated quantitative stability indicating method (SIM) for assay using HPLC is developed in accordance with applicable guidance in FDA and ICH [Q1A(R2) and Q1E]. Other characteristics tested including: Appearance, package Integrity, Color, pH, Viscosity, Moisture, Minimum weight, and Microbial limit.

Shelf Life evaluation is determined by plotting assay values in % label claim against time points; statistical linear regression analysis is drawn from Long-Term stability assay data up to 24 months. On the graph, clearly draw the lines of upper and lower acceptance criteria. The intersection point of regression line with one of the lines of acceptance criterion is to be used as shelf life.

In case of OOS result, the possible cause of an unidentifiable analytical error is thoroughly investigated. Investigation is accompanied with timely continuing sample re-injection, re-testing and re-sampling to determine the root cause. The findings are to be used to justify if the results found is invalid. Every investigation is followed by corrective action to prevent recurrence of similar deviation.

To provide safety, efficacy, quality of drug substance and drug product, data integrity responsibilities are frequently made understood, trained, audited at all personnel level in the company. BioKey commits to control data from their creation to long-term archive to ensure compliance with regulatory requirements

For Stability/Shelf Life services, we require sponsor to submit at lease 200 mg of the analyte reference standard for SIM. The amount of sample required to cover the entire length of stability studies will be determined by study proposal. Turnaround time of SIM and stability protocol is about three weeks from singing the Work Order and PO received.

Pricing for early phase HPLC Method Verification is competitive (compendial method). Negotiable if non-compendial method is requested. Cost of stability studies is charged per strength / per lot number / per condition /per time point for all the characteristics mentioned above.

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Product Testing Services
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Consumer Product Testing Services

Consumer Product Testing Services

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HPLC-PDA-ELSD
High performance liquid chromatography photodiode array evaporative light scattering detection
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