Summary of Inventions

The bioprocessing industry has grown substantially in response to the diversity of products that are now produced using living entities as recently reported by Niazi in the European Pharmaceutical Review. The new challenges in GMP manufacturing have created a significant barrier to development and manufacturing of affordable biological products. Given below are the inventions that are available for licensing for

·      Reducing the COGS

·      Fast to market biologics

·      Accessibility of technology to smaller companies

·      Improved consistency in the quality of products

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Upstream Technology

Significant changes have come in upstream technology, even though the basic design of upright bioreactor remain in place for hundreds of years. The SUBs are one example where most changes are seen but these bioreactors are yet to be accepted in large commercial manufacturing. The innovative changes provided here include:

1.     Horizontal disposition of SUBs

a.     Removes height constraints

b.     Reduces breakthrough time for gases for improved pH control

2.     Unstirred mixing

a.     Moving container instead of introducing external stirrer

b.     Reduces stress to cells and protein

c.     Mode of mixing consistent in cell expansion to commercial manufacture

3.     Mixing platform

a.     Levitation, mechanical and magnetic

b.     Low energy, no limit on volume

c.     Readily accommodated in small spaces

4.     Gas temperature control

a.     Convective temperature control

b.     Reduces stress to cells

c.     Allows immediate changes in temperature

5.     Built-in non-blocking filter

a.     Perfusion systems

b.     No risk of contamination

c.     Unlimited time without blockage

6.     Gassing

a.     Full base gassing to improve KLa

b.     Reduce stress on cells and protein

c.     Improved quality of product

7.     DOE design

a.     Multiple bioreactors on one platform

b.     Different condition in each bioreactor

c.     Fast to market

8.     Exhaust

a.     Filter-free exhaust independent of flow

b.     Exhaust condensed, frozen prior to exhausting

c.     Recirculated exhaust after removing carbon dioxide

d.     Incineration

9.     Perfusion:

a.     Built-in, non-blocking, single-use filter to retain cells

b.     Removal of nutrient media

c.     Removal of proteins

d.     Removal of any combination thereof

10.  Continuous:

a.     Capture of protein and outflow of nutrient media and cells

b.     Novel age-optimized capture

c.     Improved yield

d.     Consistent quality from same age cells

Downstream Technology

Whereas upstream technology has grown significantly over the past decade, the downstream technology remains restricted to systems and methodologies that are decades old. The innovative changes provided here include:

1.     Capture column

a.     Porous pucks holding binding media arranged in a column

b.     Bind protein from drained contents of bioreactor

c.     Washing, elution and reuse, no loss of binding media

d.     Continuous manufacturing of proteins

2.     Porous pouch

a.     Containing binding media

b.     Connected to create needed binding capacity

c.     End cycle or during cycle to remove proteins and/or metabolites

d.     Washing, elution and reuse, no loss of binding media

3.     Floating porous pouch

a.     Buoyant pouches across vertical length of bioreactor

b.     Designed to rotate thermodynamically

c.     End cycle or during cycle to remove proteins and/or metabolites

d.     Washing, elution and reuse, no loss of binding media

4.     Float column

a.     Binding media floating in enclosed compartment

b.     Continuous flow of protein solution

c.     Automated control of binding efficiency

Filtration

Filters get blocked, filter breach and filters require costly validation. One way to streamline operations is to remove such filters. The innovative changes provided here include:

1.     Non-blocking filter

a.     Hard filter scrubbed by gas or by liquid

b.     Single-use disposed inside bioreactor

c.     Allows continuous perfusion without contamination

d.     Multiple uses in other many industries

2.     Liquid filter

a.     Gases sparged through a liquid medium such as 10% sodium hydroxide to remove all particles and biological contaminants

b.     Venturi and impact circulation to remove droplets

c.     Virus-free air for laminar hoods, clean rooms

d.     Application in many industries