BSA FRACTION V
B OVINE S E RUM ALB UMINBOV I NE SERUM
ALBUMIN
PRO LIA N T B S A
Proliant is the world’s largest and mostexperienced manufacturer of animal-derived
proteins, producing a variety of grades ofFraction V BSA in large volumes with thehighest level of consistency, traceabilityand quality. We are the only manufacturerof Bovine Albumin that controls the entire
process from collection, through transportand processing. Our computer-facilitated

FE AT URE S & B E NE FITS

manufacturing plant employs a modern,+ + High Purity, Low Interference,

efficent, closed system that closely parallels
the environmental and process controls foundin traditional human albumin manufacturing.
Our commitment to quality also extends wellLow Background+ + Virtually No Detectable IgG, Endotoxin,
Enzyme or Protease Activity+ + Assay Integrity, Component Stability

beyond facility and process design. Proliant

and Cell Culture Suitability

maintains an extensive Quality Assurance+ + Origin Traceability to Facilitate

Team that is fully commited to documentationand statistical process control. Standard
Operating Procedures are built into every stepin the process, from raw material, throughprocessing, packaging, testing and process
improvement.

Regulatory Approval+ + Closed Loop Manufacturing –Minimizes Contamination andMaximizes Reproduceability+ + Superior Solubility/Filterability
for Ease of Use

Proliant’s traceability and unparalleledattention to excellence in Good Manufacturing
Practices ensures that our BSA products
meet the exacting standards demanded bydiagnostic, biopharmaceutical and researchcustomers worldwide.

+ + Responsive Customer/Technical Services+ + Manufactured from USDA-inspected
Bovine Plasma (NZ/Australia also available)+ + Manufactured According to FDA BulkPharmaceutical Chemical cGMPs+ + Validated for Clearance of TSE agents

B SA P R O D U C T
I N F O R MAT I ON
Proliant Bovine Serum Albumin is a high purity
Fraction V protein derived from the plasma

RE AGE NT GRADE

of USDA-inspected healthy animals from

Proliant albumin is also available as anabattoirs located in the United States. The

essentially lipid and fatty acid free preparation,material is initially fractionated by a modified

with levels of non-esterified fatty acids

Cohn procedure – a proprietary heat-shock

typically < 0.01% (<0.1mg/g). Proliant Fatty

method, and is further isolated from other

Acid Free BSA is used where the presenceplasma proteins and lipids by extensiveof lipids and fatty acids may cause problems,

membrane dialysis and filtration. Typical purity

such as hormone and cholesterol assays. Fatty

levels are in excess of 99%.

acid free albumin also provides maximum

For typical analytical results, please see insidebinding sites for the additon of specific fatty
acids for cell culture applications.

cover of this brochure.

Protease-free IgG-free andReagant Grade has the lowestvirtually free of contaminants

levels of total lipids, fatty

that can result in backgroundacids and free fatty acids ofinterference.

any commercially availablealbumin.

Q UA L I T Y
AS S U R A N C E
B U I LT I N
COLLECTION

TRANSPORTPROCESSING

Overseeing andWe exercise

Our modern

operating thecomplete control

closed loop systemfacilities ensuresover the transport

virtually eliminates

quality from theof components tocontaminants forvery beginning.

our facilities.

guaranteed purity.

A PPL I CATIONSDIAGNOSTICS

Solubility is outstanding with

Blocking agent forexcellent clarity, filterability

immunoassays, preventing
non-specific binding

and low UV background evenat high concentrations.

VETERINARY
Increases viral yield duringveterinary vaccine andmedicine production

VACCINE
Cultivation of Leptospira,
Borrelia and mycoplasma;virus production

BIOPHARMACEUTICAL
Serum-free and serumreduced mammalian cell
culture/cell preservation

MEDICAL DEVICE
Component of topicaland ex-vivo medical
device formulations

DI AG N O S TIC
APP LICATION S
Proliant manufactures several grades ofalbumin that are ideally suited for sensitive
immunodiagnostic and protein chemistry
applications, as well as for automated clinicalanalysis. All lots are protease-free, IgG-freeand virtually free of contaminating enzymes,
salts, heavy metals and low molecular-weightcontaminants that can result in backgroundinterference. Solubility is outstanding, withexcellent clarity, filterability and low UVbackground even at high concentrations.

C E LL C ULT URE , ME DICALDE VIC E APPLICAT IO NS
Proliant’s BSA products are very low inendotoxin, low bioburdern, have undetectableamounts of IgG and are highly solubleTypical diagnostic applications for Proliant BSA

in media – critical characteristics forinclude:veterinary and biopharmaceutical cell culture+ + Blocking agent for immunoassays,applications. In addition, our traceability andpreventing non-specific binding+ + Protein standard, diluent, control

document trail facilitates our customers’
regulatory compliance. Proliant BSA is usedsuccessfully worldwide as a component of+ + Protein/Conjugate/antibody stabilization

vaccine, biopharmaceutical and medical device+ + Surface coating agent

manufacturing. In additon, our Research and+ + Detoxification and inactivation

Development team will assist our customers

of inhibitory analytes+ + PCR optimization/stabilization+ + Immunohematology and serology

in optimizing products to work with customer
cell lines and our other serum-free media
components, such as transferrin and LiPro™
lipoprotein supplement. Typical applications
include:+ + Serum-free and serum-reduced
mammalian cell culture/cell preservation+ + Cultivation of Leptospira, Borrelia
and mycoplasma; virus production.
+ + Compontent of topical and ex-vivo
medical device formulations

MANU FACTURING
Proliant’s proprietary collection system and“Closed Loop” manufacturing process ensure
the highest level of control and availability.
The material undergoes ante and postmortem inspections to ensure it is the highest
quality edible grade before it is loaded into
Proliant owned tankers.
The manufacturing facilities utilize a closed
membrane and centrifuge system, ensuring
there is no environmental exposure. It is also acomputer-assisted process control with 100%
stainless steel tanks, piping and is fully Clean
In Place (CIP).

FE ILDING, NE W Z E ALAND
Located on the southern portion of theNorth Island of New Zealand, the facility
is essentially a mirror image of the Boone
facility, in terms of manufacturing processes
and capacity.

R EGULATORYIN FOR MATION
The manufacturing of BSA by Proliant isdesigned to ensure that neither the raw
material collection, manufacturing process nor
the manufacturing environment introduce any

From the time our product enters our tankers,

contaminants into the product. Installation,

to the moment it is loaded into the dryers,

Operation and Process Validations have been

the product is never exposed to the external

performed to ensure that equipment andenvironment.

systems function as intended and produce aconsistent, reproducible product that will meet

BO O N E, IA U SA

established specifications. All SOPs and batch

Proliant’s state-of-the-art, Bovine Serumrecords demonstrating compliance with BPC

Albumin (BSA) production facility, is centrally

cGMPs are on file at the manufacturing site

located in the United States. Spanning 50,000

and are available for inspection at an audit.

square feet, including a 10,000 square footBecause of the strong level of control overlyophilization suite, allows for extensive

collection and processing, Proliant has been

production capacity.

granted a TSE Certificate of Suitability to theProliant’s Boone facility is FDA Bulk

Monographs of the European Pharmacopoeia.

Pharmaceutical Chemical GMP’s, USDA APHIS

Additionally, Proliant is recognized by theRegistered and Inspected.

International Serum Industry Association as
being “Traceability Certified”.

PROL I A NT B OVINE SER UM ALBU MIN
TY P ICA L A N A LYSI S Please call or email us to discuss specifications
Standard Grade pH 7.0 (68100)
or pH 5.2 (68500)

Reagent-Grade(Fatty-Acid Free) (68700)

Cohn Analog™
(68300)Protein≥ 99%≥ 99%≥ 99%

Purity (Albumin)

100%

100%

100%Moisture

≤ 3%

≤ 3%

≤ 3%Ash

≤ 2%

≤ 2%

≤ 2%

pH (H20)

6.8–7.2 or 5.0–5.4

6.8–7.2

6.8–7.2

Protease

Not detected*

Not detected*

N/A

Bovine IgG

Not detected

Not detected

Not detected

Endotoxin<1 EU/mg<1 EU/mg<1 EU/mg

Bioburder (APC)<100 cfu/g<100 cfu/g<100 cfu/g

Sodium

6 mg/g

5 mg/gNAPotassium< 1mg/g< 1mg/g

NAChloride

2 mg/g< 1mg/g

NACalcium< 0.5 mg/g

< 0.3 mg/g

NAPhosphorus< 0.3 mg/g

< 0.3 mg/g

NA

Heavy Metals (Pb)

< 1ppm< 1ppmNANEFA

NA< 0.01%NASolubility (H20)

PassPassPass*Not detected by our methods, sensitivitiy of 0.0001 units/mg
Mycoplasma and virus testing by USDA 9CFR 113.53(c) can be performed on request

A B OU T
PROL I A NT
BIOLOGICALSProliant Biologicals is part of the Proliant groupof companies, leading manufacturers of protein
ingredients for food, health, nutrition and biologicals.
Founded in 1981, Proliant along with AmericanProtein Corporation, BHJ Corporation and Boyer
Valley Corporation are privately held companies of theLauridsen Group Incorporated. With over$1 billion insales and over 50 locations worldwide, The Lauridsen
Group serves human, veterinary and industrial
applications with high quality , natural source proteins.
Proliant Biologicals manufactures and markets highpurity plasma fractions. The company markets products
into the diagnostic, veterinary, biopharmaceutical, andnutraceutical and life science research industries.

ww w. proliantbiolog icals.com

2425 SE Oak Tree Court
Ankeny, Iowa 50021-7102, USAPhone (515) 433-4740
biologicals@proliantinc.com