image
image
image

BEVS Platform Technology

Baculovirus Expression Vector System (BEVS)

We have developed and patented a Baculovirus Expression Vector System (BEVS) that we use in all of our products and services. This platform leverages the natural infection process of insect cells by baculoviruses. We re-engineer the baculovirus such that it programs the infected insect cells to generate large quantities of desired recombinant protein(s). Our proprietary expresSF+ cell line has been optimized for this purpose. The end result is the production of large amounts of pure protein, generated more quickly and less expensively than other production systems.

BEVS Advantages:

Low-cost, rapid production of proteins

Correctly folded and biologically active

cGMP-qualified master virus banks and cell line

Extensive clinical use and regulatory history

Scalable to large volumes and high cell densities

FDA-qualified cell line and baculoviruses

cGMP clinical materials at an affordable price




TOP



Applications

Our BEVS platform has been successfully used for the development of a wide range of vaccines and therapeutics:

Prophylactic vaccines - for the prevention of infectious diseases

  • Influenza (seasonal and pandemic)

  • Human papillomavirus

  • Emerging pathogens (SARS)

  • Biodefense (Ebola)
Therapeutic vaccines
  • Oncology (prostate and breast cancer)

  • Diabetes
Gene therapy - using rAAV (recombinant adeno-associated virus)
  • Muscular dystrophy

  • Genetically-based lipid disorders

  • CNS disorders (Alzheimer's and Parkinson's diseases)
Biologics
  • Wound healing

  • Tissue repair

  • Antivirals (hepatitis C)

  • Anti-inflammatory diseases/arthritis
Three BEVS-generated products have progressed through Phase III clinical development:
  • Flublok - seasonal influenza vaccine; Protein Sciences Corporation

  • Diamyd - therapeutic vaccine for type I diabetes; Diamyd Medical AB

  • Glybera - gene therapy for lipoprotein lipase deficiency; uniQure
TOP



expresSF+ Cells

We have created and patented a unique Spodoptera frugiperda insect cell line, expresSF+ cells, to optimize protein production using our BEVS technology. These cells have been extensively characterized and products manufactured from them have received regulatory clearance for human clinical testing in the United States, Japan, Australia, Europe, Canada and elsewhere. A veterinary PCV-2 vaccine produced in our cells is being marketed worldwide, including in the United States, Europe and Japan.

expresSF+
Uninfected expresSF+ cells
expresSF+
AcNPV infected expres
SF+ cells


expresSF+ Advantages:

FDA-qualified

Serum-free, low cost growth media

High density growth and gene expression capability

Produces high titer AcNPV (108 PFU/ml)

Infected with low MOI

Stable for > 50 passages

18-24 hour doubling time

Do not clump or aggregate

Scalable for cGMP manufacturing


Our expresSF+ cell line has been characterized and qualified for:
  • Identity and stability

  • Freedom of mycoplasma, spiroplasma and other adventitious organism contamination

  • Freedom of retrovirus-like particles

  • Non-tumorgenicity in mice

Serum-free: expresSF+ cells do not require serum for growth or storage, and double about every 24 hours in our proprietary serum-free media. Unlike other serum-free insect cells, expresSF+ cells generate high titers of baculovirus. Therefore, a single cell line can be used for production of large quantities of protein.

High density: expresSF+ cells can be grown to a density of 108 cells/ml. At a density of 107 cells/ml, the cells are nearly 100% viable in standard suspension cultures. We have established and patented high density fermentation and fed-batch procedures to maximize protein yield. Under these conditions, cell growth is exponential from 1.5X106 to more than 70X106 cells/ml in serum-free media, and viability remains at least 98%.

Licensing agreements are available to use our expresSF+ cells. Please contact Daniel Adams, Executive Chairman and Global Head of Business Development, at 1-203-686-0800 x303.

TOP




image