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Bioanalytical Services

ACDIMA BioCenter a full-service Clinical Research Organization (CRO), is a leading provider of excellent scientific expertise with capabilities of handling challenging studies. ACDIMA BioCenter has a highly experienced team of scientists in the bioanalytical department, who are capable of taking on the difficult tasks which in turn enable us to provide customized sponsor/study requirements for method validation and sample analysis.

 

ACDIMA BioCenter’s mission is Science with Integrity.

 

The services are the product of the utilization of our bioanalytical laboratory advanced technology mentioned below:

Bioanalytical lab is GLP compliant and equipped with world class equipment:

1. Instrumentation room (LC-MS/MS systems):

  • AB Sciex API Triple Quad 4500 (Three).

  • AB Sciex API Triple Quad 4000 (Five).

  • AB Sciex API Q-trap 4500 (Four).

  • AB Sciex API Triple Quad 6500 (Two).

 

2. Sample processing laboratory:

  • Milli-Q water.

  • Refrigerated centrifuges.

 

3. Freezer rooms:

Freezer which have capacity of storing study samples in freezers (-20 °C and -70 °C) with continuous temperature monitoring and equipped with alarm system which triggers email and SMS when temperature is out of range supported by standby generator and UPS.

 

4. Balance rooms:

  • Microbalance

  • Ultra microbalance

 

Major functions:

  • ACDIMA BioCenter provides a progressive discipline for which the future holds many exciting opportunities to further reduce sample volumes, analysis cost, and environmental impact, as well as to improve sensitivity, specificity, accuracy, efficiency, assay throughput, data quality, data handling and processing.

  • ACDIMA’s Bioanalytical Department has been supporting client projects in the areas of bioanalytical method development and validation, sample analysis, reporting, and submission since the company's inception.

  • The combination of qualified members and sophisticated instrumentation enables our team to effectively carry out LC-MS/MS based bioanalytical method development and validation. 

  • Maintain high-quality standards as required by GLP principles.

  • Method development, method validation and sample analysis are done as per regulatory requirement (USFDA, EMA, GCC etc.) to serve the best quality.

  • Our ability to deliver high quality data in a timely and cost-effective manner has earned us an excellent reputation with our clients, especially with difficult assays and challenging bioanalytical methods (like 4 components of ANTI-TB).

  • Quantitative sample analysis in human matrices (blood, plasma, serum) with a throughput capacity of a large volume of samples/year. Expertise in complex bioanalysis:

- High sensitivity assays with pg/mL LLOQ

- Long-acting injectable

- Endogenous compounds

- Light and temperature-sensitive analytes

- Orally inhaled drugs

- Chiral compounds

- Steroid hormones

- Nasal Spray

  • Provide Pharmaceutical analysis service for NDMA/NDEA impurities for raw material and finished products like Metformin, Ranitidine, Candesartan, Valsartan by using LC-MS/MS.

Infrastructure and instruments:

 

Our bioanalytical laboratories are equipped with leading systems and technologies that are compliant with the Good Laboratory Practice (GLP)

Bioanalytical Department contain,

1. Instrumentation rooms

(LC-MS/MS systems):

  • AB Sciex API Triple Quad 4000

  • AB Sciex API Triple Quad 4500

  • AB Sciex API Q-trap 4500

  • AB Sciex API Triple Quad 6500

Instrumentation rooms (LC-MS/MS systems)

3. Freezer rooms:

Capable of storing study samples in freezers (-20 °C and -70 °C) with continuous temperature monitoring that is equipped with an alarm system which triggers email and SMS when the temperature is out of range supported by standby generator and UPS.

Freezer rooms

2. Sample processing laboratories:

  • Milli-Q water.

  • Refrigerated centrifuges.

Sample processing laboratories

4. Balance rooms:

  • Microbalance

  • Ultra microbalance

Balance rooms
 Bioanalytical Services | ACDIMA Center | Bioequivalence and Pharmaceutical Studies | Contract Research Organization (CRO)
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Validation and Qualification

 

All equipment and analytical instruments in ACDIMA BioCenter are valid and qualified in compliance with:

  • Good Laboratory Practices (GLP) regulations.

  • Good Clinical Practices (GCP) regulations.

  • USP chapter (1058) “Analytical Instrument Qualification”.

  • US FDA 21 CFR 211 guidance for current Good Manufacturing Practice for finished pharmaceuticals (cGMP).

  • European Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annex 15: Qualification and Validation.

  • Pharmaceutical Inspection Convention Scheme (PIC/S).

 

The type, level, and the number of qualification activities of equipment and analytical instruments depend on their nature. Based on that, there are three main groups: A, B, and C. Group A includes equipment with no measurement capability, group B includes equipment and instruments providing measured values, group C includes analytical instruments integrated with a computerized system. 

The conformance of instruments in each group with the user requirements specifications is determined according to visual observations for group A, specific function test for group B, and specific function and performance tests for group C.

 

The equipment and analytical instruments during their lifecycle are undergoing through a 4Q model; Design Qualification (DQ) Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) that covers the equipment from its order to its retirements and it consists of:

 

  • Plans: User Requirements Specification (URS), Functional Requirements Specifications (FRS), and Vendor Qualification.

  • Specifications: DQ, IQ, OQ, and PQ protocols.

  • Tests: Execution of the protocols, Standard operating procedures (SOPs), and personnel training records.

  • Maintaining the validated state: configuration management and change control, procedure, operation support, and maintenance.

  • Retirement: Retirement plan and memos.