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LPV™ Thermostability Platform

For improving the stability of vaccines and biologics

LPV Platform Overview

The LPV Platform is a proprietary formulation and process that allows vaccines and biologics to preserve stability, potency, and safety.

Many vaccines and biologics are highly sensitive to temperature and physical stress, and many must be stored between 4° C and 8° C to preserve their integrity. Without proper storage, exposure to elevated or freezing temperatures can lead to a loss in potency or reduced safety, limiting protective benefits or therapeutic effects.1

With its partners, VBI seeks to develop a next generation of vaccines and biologics which preserve stability and allow for consistently safe and effective administration in both established and emerging markets.

LPV Platform Highlights
  • Long-lasting stability across a variety of conditions: Demonstrated potency in multiple preclinical animal models, including non-human primates; demonstrated efficacy in mice and ferrets with aged vaccine formulations stored at 4° C and 40° C for up to one year.2
  • Suitable for a variety of vaccines and biologics: Can be used for either new or existing vaccines; has been used to preserve stability and potency of several classes of vaccine antigens and biologics, including protein-based, monoclonal antibodies, whole-inactivated, and live-attenuated vaccines and viral vectors.3
  • Simple and scalable process: Successfully tested in a GMP-compliant production plant at pilot levels; data demonstrates product consistency across batches.4
  • Based upon well-established lipid components: Uses novel, fully synthetic lipid combinations with well-established safety profiles; LPV lipids reduce protein aggregation and reduce other process-related (sheer) stresses.5
Jeff Baxter, VBI's President and CEO, discusses VBI's LPV Thermostability Platform.
Proof of Concept

VBI has completed proof of concept studies on a number of vaccine and biologic targets that demonstrate the LPV Platform’s ability to preserve potency under stress conditions:

VBI is working with Sanofi Pasteur to explore reformulating a Sanofi Pasteur vaccine candidate to improve stability.

VBI has entered into a research collaboration with GSK, a leading global healthcare company, to evaluate the LPV Platform.

VBI seeks to explore partnership opportunities with leading life sciences companies, academic institutions, and governments.

The Importance of Stability and Thermostability

Vaccines and biologics vary greatly in their ability to remain viable during handling, storage, and administration. The stability of a particular vaccine formulation depends on many factors including the type of antigen (active ingredient) and the presence of other vaccine components such as adjuvants, stabilizers, and preservatives.

One factor that is known to affects characteristics of all vaccines over time is temperature. Without a constant temperature in a very narrow range above freezing, many vaccines lose their potency, become ineffective, or can become hazardous. Currently, more than 90% of all vaccines require shipment in a temperature controlled supply chain or “cold chain”.10

Reliance on a cold chain increases vaccine costs by up to 20%11 and is a significant barrier to patient access in many emerging markets. In addition to maintaining the cold chain, there is a separate challenge of verifying any lapses in the chain to ensure the viability of the vaccine before it is administered, particularly in poor or remote areas.

VBI believes its LPV Platform could provide manufacturers of vaccines and biologics with significant advantages. Moreover, the critical issue of public health safety and strict quality controls could drive demand for more stable vaccines and biologics by governments and global health organizations, even in areas where a cold chain already exists.

Multiple Links in the “Cold Chain”

Vaccine efficacy is the shared responsibility of all who handle the product from the time it is manufactured to the time it is administered. When breakdowns occur, the consequences can be costly and potentially harmful.

Production and Manufacturing

The LPV Platform has several unique attributes that may allow for advantages in multiple areas of development including speed, cost, flexibility, and consistency:

  • Simple and scalable production method.
  • Suitable for new or existing formulations across all major classes of vaccines and biologics.
  • Successful pilot scale manufacture has been achieved at a GMP compliant contract facility.12
  • A combination of synthetic lipids (MPG, DCP, and Cholesterol) in proprietary ratios and methods can be tailored for desired formulation properties.
  • LPV lipids reduce moisture content during lyophilization cycles and help prevent moisture ingress, a critical factor in providing stability and thermostability.13
Six Months Storage

The LPV Platform confers stability to lyophilized cakes beyond that conferred by lyoprotectants (sucrose).14

Preclinical Data

Eight weeks of stability at 37° C was achieved with an LPV formulation of the measles component of a commercial MMR vaccine. Potency was measured in quadruplicate in VERO cells in vitro after eight weeks of storage – LPV formulations provided greater stability than standard sucrose lyophilized control or off-the-shelf reference vaccine.15

Potency Loss After Exposure to 37° C for 8 Weeks (Log10 TCID50)

An LPV formulation of a HER-2 mAb reduces moisture, increases purity, and maintains potency under stress conditions.16

Liquid bulk drug substance (Her-2-mAb-liquid) was compared to lyophilization in sucrose in the absence (Her-2-mAb-lyo) or presence of the LPV™ lipids (Her-2 mAb-LPV™).

Six month of stability at 40° C was achieved for an LPV formulation of H3N2 seasonal flu vaccine formulated at pilot scale by a contract manufacturing organization.17

References

  1. CDC Vaccine Storage and Handling Recommendations and Guildelines (http://www.cdc.gov/vaccines/recs/storage/)
  2. VBI Studies: 12BC04, 12MK01, 12FE01, Undisclosed partner feasibility studies
  3. VBI Studies: 12BC04ABCDE, 07CH12, 07CH17, Undisclosed partner feasibility studies
  4. VBI Studies: 12BC04ACDE, Reports REP-IMM-034, REP-FORM-101
  5. VBI Studies: 07CH12, Undisclosed partner feasibility studies
  6. VBI Studies: 12BC04ACDE, Reports REP-IMM-034, REP-FORM-101
  7. VBI Studies: 07CH17
  8. VBI Studies: 07CH12
  9. VBI Studies: Undisclosed partner feasibility study
  10. Biopharma Cold Chain Sourcebook 2010
  11. World Health Organization (“WHO”)
  12. VBI Studies: 12BC04E
  13. VBI Studies: 12BC04ACDE, Reports REP-IMM-034, REP-FORM-101
  14. VBI Studies: 12BC04ACDE, Reports REP-IMM-034, REP-FORM-101
  15. VBI Studies: 07CH12
  16. VBI Studies: Undisclosed partner feasibility study
  17. VBI Studies: 12BC04ACDE, Reports REP-IMM-034, REP-FORM-101

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