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Offering End-to-End Solutions
Formulation and Drug Product Development
End-to-End Services for a Wide Variety of Bioconjugates
We offer extensive end-to-end services for formulation/process development for a wide variety of bioconjugates. Our team assists from early-stage molecular assessments to development of First-in-Human (FIH) formulations to enable clinical trial starts. Additionally, we further provide commercial formulations lock and process/device development in preparation for product launches.
We are experts in developing liquid, frozen or lyophilized dosage forms filled into vials as well as special dosage forms for products containing nanoparticles and other advanced molecular complexes.
Our services include, but are not limited to:
Formulation development technical platform
Bioconjugate products developability studies, pH/buffer screening, excipients screening, formulation confirmation, forced degradation studies, and clinical in-use studies are conducted to develop the most robust formulations. The lab is equipped with all required instruments including Malvern DSC, Big Tuna, MFI, HIAC, DLS, viscometer, Stunner, Solo VPE, etc.
Lyophilization process technical platform
The lab is equipped with professional experimental instruments, including freeze drying microscope and mDSC, which are used for key thermal parameters characterization (Tg, Tc). The labs also contain a pilot lyophilizer with a variety of advanced PAT technologies consisting of wireless temperature probe, online weighing, MTM, and ControlLyo which support the accurate monitoring of the lyophilization process and guide the establishment of the design space.
Manufacturing process technical platform
Freeze thaw, mixing, filtration, filling process development and in process compatibility studies ensure optimal manufacturability. The lab is equipped with all required instruments including TFF system, mixing system, peristaltic pump, V-max, filling pump, TOC, etc.
Additionally, we provide commercial formulations lock and process/device development in preparation for product launches and the concept of QbD is utilized in every process development program.
Our instruments include, but are not limited to: