bbi solutions - enzymes

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BBI is the leading supplier of high quality enzymes to the diagnostic and research markets Over 50 years of enzyme expertise Urine Test Strips GO/GDH Biosensors Immunoassays HRP/ALP Clinical Chemistry RNase Nucleic Acid Extraction Kits Chymotrypsin and Trypsin

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Page 1: BBI Solutions - Enzymes

BBI is the leading supplier of high quality enzymes to the diagnostic and research markets

Over 50 years of enzyme expertise

Urine Test Strips

GO/GDH Biosensors

ImmunoassaysHRP/ALP

Clinical Chemistry

RNaseNucleic Acid Extraction

Kits

Chymotrypsin and Trypsin

Page 2: BBI Solutions - Enzymes

“Our Glucose Oxidase is tried, tested and proven to perform in blood glucose

monitoring 5 BILLION times every year”

BBI’s Glucose Oxidase is the key component in over 5 billion blood glucose monitoring test strips every year

But what makes it so good?

Highest levels of activity and purity –increase speed and accuracy

Multiple high purity grades available – optimise your assay, save money

Proven performance – meeting latest FDA accuracy guidelines (+/- 15%)

Batch to batch reproducibility and consistency – essential in high volume strip production

Number 1 supplier of Glucose Oxidase

Page 3: BBI Solutions - Enzymes

Why use our FAD-GDH?

Not affected by variations in oxygen levels

Optimised purification method - fewer contaminants, reduced backgrounds = better sensitivity

Improved performance for hospital based systems

Good stability 70% of activity remaining after 90 days at

50ºC Stable below -20ºC for at least 24 months

No additives or animal derived materials present

“Did you know we also supply an FAD dependent Glucose Dehydrogenase

(FAD-GDH)?”

FAD dependent Glucose Dehydrogenase

Page 4: BBI Solutions - Enzymes

Better sensitivity with FAD-GDHOur FAD-GDH’s high purity leads to a lower background signal, which enables you to measure lower glucose concentration levels – resulting in better sensitivity

Page 5: BBI Solutions - Enzymes

Our next generation FAD-GDH is ideal for customers looking to develop a product of greater accuracy to meet tightening regulatory requirements.

But what makes it so good?

Increased accuracy through improved specificity to glucose

Higher reactivity, providing a faster signal

Improved stability, enhancing reliable strip performance

Cost savings, requiring fewer units of enzyme per strip

NEW FAD-GDH – reduced xylose interference

“We offer a service and range of products

unique to the biosensor market”

Page 6: BBI Solutions - Enzymes

Improved specificity using GLD3

  GLD1 GLD3

D (+)-Glucose: 100% 100%

D (+)-Galactose: 0.41% 0.27%

D (+)-Maltose: 0.30% 0.67%

D (+)-Mannose: 4.50% 1.73%

D (+)-Xylose: 12.40% 1.60%

2-deoxy-D-glucose: 43.20% 39.8%

Specificity was measured by substituting different sugars (concentration 200mM) for glucose in the BBI FAD-GDH assay.

Page 7: BBI Solutions - Enzymes

Highest quality enzyme labels

Use the highest quality Alkaline Phosphatase and be confident in the results

Highest activity ALP on the market: >2200 glycine U/mg protein and >7000 DEA U/mg protein

High stability: less than 10% activity lost over 48 months

Benchmarked data: showing proven performance against the competition

Page 8: BBI Solutions - Enzymes

Highest quality enzyme labels

Be confident in achieving better and consistent HRP conjugation

High isozyme C content (available above 90%)

High activity levels ~280 U/mg with some batches achieving >300 U/mg

Highly available amino groups for clean conjugation

Planned purchase of horseradish roots gives a controlled and consistent supply

Page 9: BBI Solutions - Enzymes

Urease for clinical chemistry and biosensorsBBI is the leading manufacturer of Urease for diagnostic applications

Proven performance in liquid and powder reagents

High purity for biosensor applications

Manufactured in high volumes to reduce costs

Batch to batch reproducibility enabling consistent formulations

Page 10: BBI Solutions - Enzymes

Clinical Chemistry

Catalase

Cholesterol Esterase

Cholesterol Oxidase

Creatinase

Creatininase

Glucose-6-Phosphate DH

Glucose Dehydrogenase (FAD)

Glucose Oxidase

Beta Glucosidase

Beta Glucuronidase

Glutamate Dehydrogenase

Lactate Dehydrogenase

Malate Dehydrogenase

Mutarotose

Our diagnostic enzymes

Peroxidase

Phosphoenolpyruvate Carboxylase

Sarcosine Oxidase

Urease

Uricase

Xanthine Oxidase

Immunoassay

Alkaline Phosphatase

Peroxidase

Biosensor

Cholesterol Esterase

Cholesterol Oxidase

Glucose Dehydrogenase (FAD)

Glucose Oxidase

Urease

Uricase

Urine Test Strips

Glucose Oxidase

Peroxidase

BBI flagship product

Page 11: BBI Solutions - Enzymes

“Our team has been manufacturing

chymotrypsin for over 40 years”

Over 40 years enzyme extraction experience

Large scale extraction facility

Our optimised process delivers the highest quality material

Well controlled procedure ensuring batch to batch consistency

Direct relationship with raw material suppliers offering secure supply

True bovine origin - piece of mind on origin of material

Certificate of suitability/EDQM approved raw material – we only source from BSE-free countries

Leading manufacturer of bovine chymotrypsin

Page 12: BBI Solutions - Enzymes

Chymotrypsin – consistent, high quality material

1900180017001600150014001300

LSL

LSL 1250Target *USL *Sample Mean 1532.03Sample N 160StDev(Within) 98.1849StDev(Overall) 122.037

Process Data

Cp *CPL 0.96CPU *Cpk 0.96

Pp *PPL 0.77PPU *Ppk 0.77Cpm *

Overall Capability

Potential (Within) Capability

% < LSL 0.63% > USL *% Total 0.63

Observed Performance% < LSL 0.20% > USL *% Total 0.20

Exp. Within Performance% < LSL 1.04% > USL *% Total 1.04

Exp. Overall Performance

WithinOverall

Process Capability of Chymo (U/ mg)

Page 13: BBI Solutions - Enzymes

Chymotrypsin – batch to batch consistency

Dec-12 Jan-13 Jan-13 Mar-13 Apr-13 May-13May-13 Jun-13 Jul-13 Aug-13 Aug-13 Oct-13 Nov-13 Jan '14 Feb '14 Feb '14 Mar '140.0

200.0

400.0

600.0

800.0

1000.0

1200.0

1400.0

1600.0

1800.0

2000.0

Chymotrypsin Activity (U/mg)

Page 14: BBI Solutions - Enzymes

“Our bovine trypsin has been produced at the

same facility for more than 40 years by enzyme extraction experts”

Leading manufacturer of bovine trypsin

Over 40 years experience extracting pancreatic enzymes

Our optimised process delivers the highest quality material

Well controlled procedure ensuring batch to batch consistency

Direct relationship with raw material suppliers offering secure supply

True bovine origin - piece of mind on origin of material

Certificate of suitability/EDQM approved raw material – we only source from BSE-free countries

Page 15: BBI Solutions - Enzymes

Trypsin – consistent, high quality material

450042003900360033003000

LSL

LSL 3000Target *USL *Sample Mean 3943.95Sample N 83StDev(Within) 197.744StDev(Overall) 332.217

Process Data

Cp *CPL 1.59CPU *Cpk 1.59

Pp *PPL 0.95PPU *Ppk 0.95Cpm *

Overall Capability

Potential (Within) Capability

% < LSL 0.00% > USL *% Total 0.00

Observed Performance% < LSL 0.00% > USL *% Total 0.00

Exp. Within Performance% < LSL 0.22% > USL *% Total 0.22

Exp. Overall Performance

WithinOverall

Process Capability of Trypsin (U/ mg)

Page 16: BBI Solutions - Enzymes

Trypsin – batch to batch consistency

Jan-

13

Feb-1

3

Feb-1

3

Mar

-13

Mar

-13

Mar

-13

Apr-1

3

Apr-1

3

May

-13

May

-13

Jun-

13

Jun-

13

July-

13

July-

13

July-

13

Aug-1

3

Aug-1

3

Sept-1

3

Oct-1

3

Nov-1

3

Dec-1

3

Feb-1

4

Feb-1

4

Mar

-14

0

500

1000

1500

2000

2500

3000

3500

4000

4500

5000

Trypsin activity (U/mg)

Act

ivit

y (U

/mg

)