Analytical Services
Beyond biomanufacturing: Analytical services
An in-house dedicated Quality Control laboratory for testing and release of raw materials, in-process control/testing, and release of Drug Substance (DS)/Drug Product (DP). Ability to provide stability and comparability studies along with critical environmental monitoring, cleaning validation support, management of sample and reference standard and supporting audits. The diverse team of specialists can assist clients address an array of analytical projects while staying up to date with GMP requirements and guidelines.
Raw Materials and
Chemicals
Chemicals
Microbilogy and
Environmental Monitoring
Environmental Monitoring
Laboratory
Analysis
Analysis
Stability
Studies
Studies
Method Validation
and Transfer
and Transfer
Raw Materials and Chemicals
The BMC can provide a wide range of general and physico-chemical analysis as well as perform analytical methods as per US Pharmacopeia (USP) and European Pharmacopeia (EP) guidelines.
Technique/Equipment/Analysis
Karl-Fisher: Colometric & Volumetric Titration
Density Measurement
FIR: Fourier-Transform Infrared Spectroscopy
Viscosimetry Measurement
Raman Spectroscopy
Turbidity Assessment
Melting Point Determination
Identification Assay
Osmolality: Aqueous solutions
USP & EP Method
Refractometry
Microbiology & Environmental Monitoring
Let it be for water, air or surfaces, our team can support you in the monitoring of quality indicator microorganisms, ensuring your facility meets environmental requirements.
Technique/Equipment/Analysis
LAL Endotoxin: Limulus Amebocyte Lysate Assay
Microorganisms Identification
Bioburden: Total Aerobic Microbial Count
Total Organic Carbon Analysis
Bioburden: Total Yeast Mold Count
Microscopy
Total Organic Carbon
Conductivity
Laboratory Analysis
With a cell culture platform for cell-based assays, our installations namely encompass biological/immuno-enzymatic assays, along with the standard assays of the industry (GC, HPLC, pH…).
Technique/Equipment/Analysis
SDS-PAGE: Gel Electrophoresis
Visual inspection according to defined standards
ELISA: Enzyme-Linked Immunosorbent Assay
Content or purity determination by RP-HPLC
pH: Aqueous solutions
Residual DNA Determination by Fluorescence Assay
Cell-based Assays & Cell Line Management
Conductivity Determination
Viral Titer
Gas Chromatography
Spectrophometry: Absorbance & Colorimetric Assay
Plate Assays
Stability Testing
The BMC can help you with your regulatory compliant stability strategy and offer stability testing for various biologics.
Stability Aspects
Long Term & Accelerated Program
Stability Protocol
Validated Stability Chambers
Stability Report
Temperature & Humidity Monitoring
Drug Substance
Stability Testing
Drug Product
Method Validation & Testing
Ensure that your analytical methods are validated as per industry standards. Our experts handle method validations and transfers as per regulatory guidelines such as ICH Q2(R1).
Validation Characteristics
Accuracy
Limit of Quantification
Repeatability
Range
Intermediate Precision
Robustness
Linearity
Stability-Indicating Property
Specificity
Inter-Laboratory Comparability
Limit of Detection
USP & EP Methods