Drug Product Development Services
We support our partners by de-risking the development of novel therapies. Leukocare is an expert in sterile formulation development and supporting analytical and data-science services. Our approach combines our formulation expertise with data science to achieve superior drug product formulation. We can also extend your scientific workbench utilizing our team, expertise, and vast analytical methods to speed up your development timelines.
Accelerate drug product development with our flexible, modular SMART formulation services. Covering traditional to cutting-edge modalities like ATMPs, we provide different service options, from buffer screening to fully tailored, comprehensive formulation development.
Drug Substance Characterization
Gain deeper insights into your Drug Substance and assess its CMC developability to pinpoint the optimal lead candidate, identify degradation sites, assess stability, and define your development strategy.
Optimize candidate selection with Leukocare's multifaceted in silico and in vitro characterization, enabling faster, data-driven decisions while minimizing the use of drug substance. We assess potential therapeutic candidates for drug-like properties, formulability, manufacturability, and administrability profiles.
Supporting your root cause analysis by categorizing the particles and then identifying their nature and potential origin. Our wide range of methods identify and characterize particles from submicron to visible.
Data Science Services
Speed up your drug product development with advanced data science, maximizing insights per wet lab experiment, enhancing drug substance understanding, and enabling more comprehensive conclusions compared to the wet lab alone. Our data science services expedite timelines through in silico analysis, even with limited drug substance.
Leukocare offers comprehensive stability testing services, from early stages of development to data-science-based shelf life prediction to in-use stability studies. This supports your stability data package, facilitating informed shelf-life assessment and regulatory filing. Our robust analytics methods assist in defining and evaluating the Critical Quality Attributes (CQAs) of your Drug Product.
Forced Degradation Studies
Improve your formulation development with ICH Q1A testing services to determine the stability of your drug substance and its degradation products under harsh conditions. Incorporating forced degradation testing thoroughly assesses product stability, degradation pathways, and kinetics.
Primary Packaging Assessment
Maintain stability and ensure customer acceptance by carefully selecting primary packaging materials. We evaluate the stability, sterility, and potency of complex biopharmaceuticals and drug products which can be affected by the primary packaging.
Non-GMP Processing & Manufacturing
Flexible small-scale production options for various modalities (up to BSL-2) to assist your drug product process development or supply toxicology studies. Our services range from early-stage evaluations to late-phase development and transfer.