QCL is a privately owned Contract Development and Manufacturing Organization co-founded by Dr. Yousry Sayed in 1998. Continuously led by Dr. Sayed, QCL has grown organically to encompass raw material and compendial testing, finished product testing, large molecule testing, product development, and clinical trial material manufacturing and packaging. Our sweet spot is pre-formulation, product development, and getting clinical trial materials to the clinic on aggressive timelines. We provide all the analytical development and validation, execution of stability studies, and testing of APIs, Finished Products and Raw Materials.
QCL currently employs over 250 people within a 90,000 ft², six-building “campus” maintaining one FDA registration and multi-disciplinary DEA registrations. The addition of a newly constructed 110,000 ft2 facility brings expanded laboratory space and a sterile fill/finish capability which will launch in 2024. Some of our Subject Matter Experts may also be found HERE.
Quality Chemical Laboratories provides R&D and GMP analytical testing services for a variety of finished dosage forms, APIs and raw materials to include method development/validation/qualification and transfers as well as release and stability testing. QCL houses over 100 HPLCs with a variety of detectors, Dissolution Apparatus 1 and 2, UPLCs, LC-MS, GC-MS, ICP-MS, IC, and XRPD along with a variety of specialized equipment.
Raw Material Testing
QCL was founded on raw material testing and continues as a core competency with expertise in multiple compendia (USP, EP, JP, BP, ACS, FCC, etc.). Experience with the nuances of compendial testing has resulted in QCL as a trusted and reliable resource for clients delivering high quality and hitting aggressive timelines.
QCL maintains a full-service microbiology laboratory – Microbial Examination, Endotoxins, Sterility, Particulate Matter, Antibiotic Assays, Water activity, Antimicrobial Effectiveness, and Water System Validations.
Large Molecule/ Biotechnology Testing
Quality Chemical Laboratories provides large molecule analytical method development, validation and testing. QCL’s capabilities include protein identity, potency, stability, and concentration as well as enzyme assays and host cell contamination. Current equipment includes SpectraMax i3x, Ella, Maurice, and Applied Biosystems.
Elemental Impurities Testing
QCL performs method development/validation and routine testing for Elemental Impurities per USP <231>, <232> and ICH Q3D. Our Metals experts work with our clients to decode testing requirements per USP and perform risk assessments determining metals or catalysts which may be present in the finished product. Once identified, a method is validated, and routine testing may begin.
Quality Chemical Laboratories provides formulation development services on a variety of oral dosage forms- tablets, minitablets, capsules, gels, films, and oral solutions with expertise in taste masking, enteric coating, aqueous film coating, as well as immediate or controlled release tablets. We can also provide formulation development services for parenterals. QCL provides pre-formulation studies, prototype development/ dosage determination, process/ scale up development linking to our early phase Clinical Trial Material manufacture in a cGMP environment. We pride ourselves on being flexible, nimble and responsive while allowing science to drive decisions.
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Quality Chemical Laboratories maintains a 6,000 ft² GMP facility for early-phase CTM manufacture. The GMP facility boasts 7 suites with negative pressure, a GMP warehouse, and a controlled substances vault. GMP packaging capabilities include thermoform blistering, blistering with Nitrogen overlay, and bottling with induction seal. These suites are in close proximity to the analytical development and testing labs. Capabilities include an automated encapsulator, bi-layer compatible tablet press, cold form blister packaging along with supporting tablet dedusters, and capsule polishers. Additional capabilities can be added to meet customer needs.
Stability Storage and Testing
Quality Chemical Laboratories performs stability studies at standard ICH conditions. The 12,000 ft³ chambers are validated, have backup power generators, and continuous temperature and relative humidity monitoring with a 24/7 response team should excursions occur. Additionally, QCL supports Analytical and Formulation Development through Photostability Studies.
Dr. Sayed provides custom synthesis services on an mg to kg scale. Impurities and degradation products can be identified throughout a product’s lifecycle. QCL routinely synthesizes impurities, reference standards, and markers while characterizing them to support analytical development and product development. Dr. Sayed is available to suggest improvements to synthetic pathways to improve purity and/or increase yields.
Quality Chemical Laboratories has the technical knowledge, flexibility, and integrity to advance our clients’ product development goals to clinic. Most often, clients feel they are getting more than what they have paid for.
“We do what is scientifically right and treat our clients as partners or extensions of QCL. If a client has a problem, QCL has a problem.”
-Dr. Yousry Sayed, President Quality Chemical Laboratories