Biologics and Biosimilars: Enabling Innovation Through Advanced Formulation Development
Biologics and biosimilars are transforming modern medicine, offering targeted, effective therapies for a wide range of conditions — from autoimmune diseases to cancer and rare genetic disorders. Unlike traditional small-molecule drugs, biologics are complex, large-molecule therapeutics derived from living cells. Their development and formulation present unique scientific and technical challenges, requiring specialized expertise and innovation.
With deep knowledge in biopharmaceutical formulation and a robust data science backbone, we provide state-of-the-art formulation development services tailored to the demands of modern biologics — including cutting-edge high-concentration formats, liquid and lyophilized formulations, and the rapidly evolving field of biosimilars.
Formulation Development Services: Precision Meets Performance
Leukocare’s formulation services are designed to accelerate development while optimizing quality, stability, and manufacturability. Our platform integrates advanced formulation know-how with a systematic, data-driven approach that goes beyond trial and error.
Key focus areas include:
High-Concentration Biologics
Biologics with high dosage requirements often demand high-concentration formulations to enable subcutaneous administration and improve patient convenience. However, increased protein concentrations pose risks of viscosity, aggregation, and instability. Leukocare specializes in developing stable, manufacturable high-concentration formulations that maintain efficacy while minimizing immunogenicity and process challenges.Liquid and Lyophilized Formulations
We offer tailored solutions for both liquid (ready-to-use) and lyophilized (freeze-dried) biological products. While liquid formulations are preferred for ease of administration, lyophilized formulations provide superior long-term stability, especially under stress conditions or for global distribution. Our deep understanding of excipients and stabilization strategies allows us to balance shelf life, reconstitution time, and product integrity for each target molecule.Data-Driven Formulation Design
Leveraging our proprietary Data Science Formulation Platform, we systematically identify optimal excipient combinations and predict formulation behavior under various conditions. This rational, model-based approach improves success rates, reduces development timelines, and minimizes resource usage — all critical factors in a competitive biologics market.
Biosimilars: Formulation as a Strategic Advantage
The biosimilar landscape is becoming increasingly competitive, with formulation emerging as a key differentiator. While biosimilars must closely mirror the reference product in efficacy and safety, their formulations may differ — offering opportunities for innovation and improvement.
Leukocare supports biosimilar developers in addressing critical formulation questions:
How can we improve stability or shelf life compared to the originator?
Can we enhance usability by creating a pre-filled syringe or auto-injector format?
What excipients allow patent-space freedom while maintaining compatibility and performance?
Our deep understanding of formulation-patent landscapes and regulatory expectations enables us to help biosimilar companies not only match but potentially outperform reference products — through better patient convenience, manufacturability, and global market readiness.
Partner with Leukocare: Formulation-First. Science-Led. Future-Ready.
Biologics, high-concentration biologics and biosimilars require more than formulation – they demand precision science, regulatory foresight, and a deep appreciation for complexity. At Leukocare, we combine all these capabilities under one roof. Whether you're advancing a novel monoclonal antibody, reformulating a legacy product, or building a competitive biosimilar, our experts work as an extension of your team — to turn formulation into a strategic advantage.
Let’s move your biologic forward — with the power of intelligent formulation.
Case Study
Up-concentrating an antibody using a standard formulation does not always result in a stable drug product. The up-concentrated commercially available formulation (red) is significantly less stable as it results in a drastically increased rate of aggregation. In comparison, Leukocare’s HighCon antibody formulation (blue) achieved a 2-fold higher concentration while stably preventing any increase in aggregate formation over time.
