Product Services Team has technical expertise in analytical
development & quality control (QC). The analytical development & QC
team offers specialized contract laboratory services including:
QC release and stability testing is supported by analytical method development
and cGMP Drug Product stability testing according to ICH guidelines. The Drug Product
QC Team can help to define shelf-life, specifications and develop a drug product
control strategy for IND/IMPD or BLA/MAA, and design Quality-by-Design and
Breakthrough therapy submissions.
state-of-the-art particle lab is able to characterize submicron and subvisible
particles using complementary methods covering the entire nano- and
micro-particle ranges: DLS, SLS, AF4, NTA, RMM, CC, MFI, LO, SEM, and visual
inspection. The particle lab can help design an adequate subvisible particle
control strategy including specification setting to meet current health
authority requirements and beyond.
forensic chemistry group offers extractable/leachable studies for container
closure systems and process & manufacturing equipment. The team has exceptional industry experience in the design and execution of drug product extractable/leachable
control strategies and risk assessments. Together with the particle lab, the
forensic chemistry group offers fast-track particle contamination root cause
investigation in drug product processing and manufacturing.
For more information, please contact our Drug Product Services Experts at: firstname.lastname@example.org