Your Molecule
Your Molecule
Gene Therapy
Gene Therapy
Advanced Formulation and Stabilization for Viral Vector–Based Products
Early risk identification to design stable, patient-ready drug products
Protecting vector integrity and potency from bench to bedside.
Cell and gene therapies are transforming medicine, delivering curative options for diseases once thought untreatable. Viral vectors—such as AAV, Lentivirus, and HSV—are at the forefront of this revolution, but their fragility presents enormous formulation challenges. They are sensitive to shear, freezing, pH changes, and temperature stress. To ensure patient safety and treatment efficacy, formulations must protect viral integrity, preserve infectivity, and extend stability.
Why gene therapy requires special attention
Why gene therapy requires special attention
Gene therapy programs often hinge on small batches of highly valuable material. Every step of development must conserve vector integrity and functionality while generating data robust enough for regulatory review. Unlike proteins or small molecules, viral vectors can lose potency from subtle environmental changes, including freeze-thaw cycles, agitation, or minor pH shifts. They are also prone to aggregation, capsid instability, and loss of infectivity.
These sensitivities make early formulation development critical. By designing protective excipient systems and optimizing buffer conditions, we can prevent degradation and extend usable shelf life. Incorporating data-driven design and structured DoE reduces trial-and-error and ensures more reliable outcomes, enabling programs to move faster with less risk.
Explore our full modalities hub
Gene therapy programs often hinge on small batches of highly valuable material. Every step of development must conserve vector integrity and functionality while generating data robust enough for regulatory review. Unlike proteins or small molecules, viral vectors can lose potency from subtle environmental changes, including freeze-thaw cycles, agitation, or minor pH shifts. They are also prone to aggregation, capsid instability, and loss of infectivity.
These sensitivities make early formulation development critical. By designing protective excipient systems and optimizing buffer conditions, we can prevent degradation and extend usable shelf life. Incorporating data-driven design and structured DoE reduces trial-and-error and ensures more reliable outcomes, enabling programs to move faster with less risk.
Explore our full modalities hub
Our expertise
Our expertise
Leukocare brings extensive experience across multiple viral platforms:
● Non-enveloped DNA viruses (e.g., AAV, Adenovirus, Polio): require excipient support to prevent aggregation and protect capsid integrity.
● Enveloped DNA viruses (e.g., HSV, HBV, EBV, MVA): fragile lipid envelopes prone to disruption; protection strategies maintain infectivity.
● Enveloped RNA viruses (e.g., VSV, Measles, Influenza): highly pH- and temperature-sensitive; stabilization prevents envelope degradation and RNA hydrolysis.
● Virus-like particles (VLPs): particle integrity and conformational stability are critical for immunogenicity and manufacturing feasibility.
Leukocare brings extensive experience across multiple viral platforms:
● Non-enveloped DNA viruses (e.g., AAV, Adenovirus, Polio): require excipient support to prevent aggregation and protect capsid integrity.
● Enveloped DNA viruses (e.g., HSV, HBV, EBV, MVA): fragile lipid envelopes prone to disruption; protection strategies maintain infectivity.
● Enveloped RNA viruses (e.g., VSV, Measles, Influenza): highly pH- and temperature-sensitive; stabilization prevents envelope degradation and RNA hydrolysis.
● Virus-like particles (VLPs): particle integrity and conformational stability are critical for immunogenicity and manufacturing feasibility.
Ready to talk about your bispecific formulation strategy?
Ready to talk about your bispecific formulation strategy?
Turning complex molecules into robust drug products
Key Focus Areas
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Let’s Build the Right Formulation — Together
Partner with Leukocare for tailored, data‑driven solutions that bring your biologics closer to patients.
Let’s Build the Right Formulation — Together
Partner with Leukocare for tailored, data‑driven solutions that bring your biologics closer to patients.
How we support you
Expertise across AAV, Lentivirus, HSV, and other viral vectors.
Freeze-thaw optimization strategies that preserve vector integrity during storage and transport.
Formulations designed to maintain biological activity, potency, and infectivity across the full product lifecycle.
Stability programs tailored to regulatory and clinical expectations.