Thousand Oaks Biologics maintains a robust formulation development platform producing liquid vials, prefilled syringes (PFS) and lyophilized vials. The formulation team develops stable low- and high-concentration formulations for mAbs, bispecifics, fusion proteins and ADCs, and supports protein co-formulations with targeted stability assessment.
screening is guided by the protein’s physicochemical profile. Preliminary screening (two rounds) evaluates pH/buffer systems and excipient classes (stabilizers, surfactants), followed by a confirmatory round to finalize formulation and primary packaging.
convert the selected formulation into a manufacturable process to support tech transfer and scale-up, including bulk freeze/thaw, bulk mixing, sterile filtration, fill/finish parameter studies and lyophilization cycle development for GMP pilot/commercial runs.
using QbD and risk-based tools, we assess CPPs via experimental designs (OFAT, DoE, worst-case) for mid-to-high-risk parameters (formulation factors; freezing/thawing, mixing, filtration, filling parameters). Post-study risk assessment produces a process characterization report and risk-control strategy.
primary packaging is selected from platform materials and subjected to container compatibility and container-closure integrity testing per client requirements.
