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Biologic Injectable Formulation

Injectable Formulation Development

Developing injectable formulations presents challenges in ensuring biologic stability at therapeutic doses and seamless compatibility with devices and administration. To overcome these obstacles, we prioritize safeguarding your biotherapeutics stability and solubility, creating a product that best serves your patient population and market opportunity.

Achieve targeted drug delivery with our team’s expertise in biologic injectable formulations. With extensive experience across different therapeutic areas and delivery technologies, we provide solutions for a seamless transition from research to clinical development.
After establishing method feasibility, our team optimizes the process to ensure appropriate resolution and achievable detection limits. Before testing begins, we also determine linearity, precision, accuracy, and specific method development to anticipate acceptance criteria and pre-validation method performance.
From the first step to the last, we provide the analytical implementation needed to advance your biologic with confidence.

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Routes Of Administration


The subcutaneous administration of biologics is gaining popularity for improved patient compliance and extended therapeutic patents. However, this method presents challenges in achieving sufficient dosage within volume limits and ensuring protein stability under pH, osmolality, and viscosity constraints. Device compatibility with commercial prefilled syringes and autoinjectors is also problematic. Our team offers valuable insights to overcome these obstacles and ensure smooth progress in formulation development.


Many targeted delivery biotherapeutics are administered intramuscularly because the deep injection into muscular tissues ensures rapid adsorption. This method is commonly used for vaccines.


Most biologics are administered systemically through intravenous infusion. Biologics must be compatible with the diluent and administration materials to ensure safe dosing and limited immunogenicity. As new safety guidelines emerge, clinical entry of biotherapeutics requires assessments of additional administration components like closed system transfer devices (CSTDs).

Integrated Laboratory Services

Our experts provide comprehensive support across drug and device development functions including CMC, drug delivery, device development, pharmacokinetics, bioanalytics, new product planning, commercial supply, and expert strategic consulting.

Our teams ensure development, manufacturing, and clinical success by focusing on the unique physicochemical properties of each biotherapeutic API and their target product profiles.

Our scientific staff specializes in high-concentration biologic formulation development for subcutaneous administration and intramuscular administration, including aggregation-prone peptide development.

Comprehensive Support

When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts can add power to your project.