Quality Chemical Laboratories
Quality Chemical Laboratories (QCL) is a contract research, development, and manufacturing organization specializing in pharmaceutical and biopharmaceutical services. Founded in 1998 and led by President & CEO Dr. Yousry Sayed, QCL offers a wide range of services including analytical development, GMP manufacturing, formulation development, raw material testing, microbiology, elemental impurities testing, and custom synthesis. The company is committed to high-quality, cGMP-compliant services, continuous improvement, and supporting clients from early research through commercialization. With expanding facilities and a dedicated team of experts, QCL aims to be a leading partner in pharmaceutical development and manufacturing.
Industries
Nr. of Employees
medium (51-250)
Quality Chemical Laboratories
3400 Enterprise Drive, Wilmington, NC 28405
Products
Analytical Development
Provides R&D and GMP analytical testing services for various finished dosage forms, APIs, and raw materials, including method development, validation, qualification, and transfers, as well as release and stability testing.
Raw Material Testing
Offers comprehensive raw material testing services, including compendial testing, method development, qualification, and validation, ensuring compliance with multiple compendia such as USP, EP, JP, BP, ACS, and FCC.
GMP Manufacturing
Maintains a GMP facility for early-phase clinical trial material manufacturing, including capabilities for encapsulation, tablet pressing, blister packaging, and bottling.
Formulation Development
Provides formulation development services for various oral dosage forms and parenterals, including pre-formulation studies, prototype development, process scale-up, and stability studies.
Stability Storage and Testing
Conducts stability studies at standard ICH conditions with validated chambers, backup power, and continuous monitoring, supporting analytical and formulation development through photostability studies.
Microbiology
Maintains a full-service microbiology laboratory offering microbial examination, endotoxins, sterility, particulate matter, antibiotic assays, water activity, antimicrobial effectiveness, and water system validations.
Analytical Development
Provides R&D and GMP analytical testing services for various finished dosage forms, APIs, and raw materials, including method development, validation, qualification, and transfers, as well as release and stability testing.
Raw Material Testing
Offers comprehensive raw material testing services, including compendial testing, method development, qualification, and validation, ensuring compliance with multiple compendia such as USP, EP, JP, BP, ACS, and FCC.
GMP Manufacturing
Maintains a GMP facility for early-phase clinical trial material manufacturing, including capabilities for encapsulation, tablet pressing, blister packaging, and bottling.
Formulation Development
Provides formulation development services for various oral dosage forms and parenterals, including pre-formulation studies, prototype development, process scale-up, and stability studies.
Stability Storage and Testing
Conducts stability studies at standard ICH conditions with validated chambers, backup power, and continuous monitoring, supporting analytical and formulation development through photostability studies.
Microbiology
Maintains a full-service microbiology laboratory offering microbial examination, endotoxins, sterility, particulate matter, antibiotic assays, water activity, antimicrobial effectiveness, and water system validations.
Services
Method development, qualification/validation, transfers and routine analytical testing for APIs, finished products and raw materials.
Compendial testing to pharmacopeial standards for raw material acceptance and release.
Microbial enumeration, sterility testing, endotoxin testing, water system validation and antimicrobial effectiveness testing.
Protein and biologic analytics, potency and stability assays, enzyme assays, host-cell contaminant testing, residual DNA and cell-based assays.
Formulation design for oral and parenteral dosage forms, taste-masking, coating, controlled-release strategies and scale-up support to clinical manufacture.
Manufacture and packaging of clinical trial materials in dedicated GMP suites, including blistering, bottling, encapsulation and tablet press operations.
Method development, qualification/validation, transfers and routine analytical testing for APIs, finished products and raw materials.
Compendial testing to pharmacopeial standards for raw material acceptance and release.
Microbial enumeration, sterility testing, endotoxin testing, water system validation and antimicrobial effectiveness testing.
Protein and biologic analytics, potency and stability assays, enzyme assays, host-cell contaminant testing, residual DNA and cell-based assays.
Formulation design for oral and parenteral dosage forms, taste-masking, coating, controlled-release strategies and scale-up support to clinical manufacture.
Manufacture and packaging of clinical trial materials in dedicated GMP suites, including blistering, bottling, encapsulation and tablet press operations.
Expertise Areas
- Analytical development and validation
- Compendial raw material testing
- Microbiology and sterility testing
- Large-molecule/biopharmaceutical analytics
Key Technologies
- High-performance liquid chromatography (HPLC/UPLC)
- Gas chromatography (GC) and GC-MS
- Liquid chromatography–mass spectrometry (LC-MS)
- Inductively coupled plasma mass spectrometry (ICP-MS) for elemental analysis
News & Updates
QCL is planning to expand its facilities by the end of 2023, including a new structure to enhance testing, validation, and manufacturing capabilities.
The recently finished industrial facility for QCL is poised to create more pharmaceutical job opportunities in the region.
Unravel Biosciences partners with QCL for manufacturing and development of therapeutics.
QCL is planning to expand its facilities by the end of 2023, including a new structure to enhance testing, validation, and manufacturing capabilities.
The recently finished industrial facility for QCL is poised to create more pharmaceutical job opportunities in the region.
Unravel Biosciences partners with QCL for manufacturing and development of therapeutics.