 |
ขน U.S. BIO-TECHNOLOGIES
INC(FBS)
ขน SOUTH PACIFIC SERA LIMITED(DBS)
|
|
| U.S. Bio-Technologies Inc. has become
a major supplier to the global biotechnology industry. Founded
in 1999 in the United States, U.S. Bio-Technologies Inc. has
rapidly grown to its current position in the cell culture industry.
The company's products are available to the research and the
biopharmaceutical industry worldwide. U.S. Bio-Technologies
Inc. provides all animal serum, in compliance with GMP pharmaceutical
standards. In the development of serum,
U.S. Bio-Technologies Inc. has built a world-wide network
for the collection of raw material that is directly supervised
by Quality Assurance staff. Each batch must meet the specifications
of U.S. Bio-Technologies Inc.'s test parameters before it
is released for customer testing and sale.
Contributing to U.S. Bio-Technologies Inc.'s
success has been its ongoing commitment to research and development,
which has led to a range of proprietary, safe products of
uncompromising quality.
|
| |
| As a global supplier of cell culture products,
U.S. Bio-Technologies Inc. is committed to providing our customers
with a comprehensive range of carefully tested and approved
products. We strive for long-term customer relationships by
placing emphasis on delivering excellent service and maintaining
flexibility. |
| Our vision is to provide quality products complimented
by our pursuit of research activities that meet the needs of
today's biotechnology industry and ultimately improves the quality
of life for all mankind.
Our continued success depends on the cooperation
and efforts of our employees, their commitment to the organization
and our customers, and their active participation in future
innovations.
|
| U.S. Bio-Technologies Inc. takes pride in offering
a comprehensive range of tissue culture grade serum. Our production
facilities are designed to meet the demands of processing biological
and blood based products in strict compliance with current Good
Manufacturing Practices (cGMP's) guidelines and USDA regulations.
Each aspect of production and testing is performed and monitored
by a highly trained professional staff. All our products meet
the highest standards of performance prior to our release for
sale.
All processes are performed according to written
documents covering every aspect of each procedure involved.
Verification of origin, processing and testing, are the factors
that control the quality of each batch, enabling U.S. Bio-Technologies
Inc. to offer only products of the highest quality.
A lot document indicates the source, manufacturing
and testing details of each product lot, for which U.S. Bio-Technologies
Inc. confidently offers a certificate of analysis.
|
| Approving USDA authority constantly inspects
the animals from which our serum is collected. Blood collection
is by cardiac puncture, venipuncture, or abattoirs open collection
technique, depending on the type of serum. The blood is obtained
from inspected, disease free animals and processed with no added
preservatives, utilizing our proprietary bag to bag closed system
of collection and centrifugation methods. Donor serum is collected
from veterinarian inspected controlled herds.
The material from which the blood bags are
fabricated meets USP Class VI requirements for plastics and
is biologically compatible and durable.
|
| The temperature is carefully controlled during
the processing in order to maintain the integrity of the serum.
Prior to pooling, all raw serum is routinely tested for bioburden,
endotoxin and hemoglobin levels, and only those containers which
meet our stringent criteria are released for further processing.
The serum is filtrated through a series of
varying porosity filter to 0.2µ and, in the case of
Fetal Bovine Serum, triple 0.1µ filters, using true
pooling techniques. Maintenance of low temperature is strictly
adhered to during all processing steps. After sterile filtration
in a validated Class 100 environment, serum is immediately
frozen and maintained at, or below, -20?. The complete procedure
is conducted in an environmentally controlled area.
|
| All serum is packaged in manufacturer validate,
gamma irradiated polyethylene terephthalate copolyester(PETG)
plastic bottles, meeting USP Class VI requirements, for complete
assurance of bottle sterile, materials and integrity. Serum
is routinely packaged in 100? and 500? bottles, although other
sizes are available upon request.
To maintain frozen conditions, serum products are shipped
in insulated boxes with dry ice.
|
|
| Tests for sterile filtered serum are listed
below and are performed according to the guidelines listed in
the Code of Federal Regulations(CFR) issued by the Food and
Drug Administration(FDA) and the United States Department of
Agriculture(USDA), pertaining to animals, and the United States
Pharmacopoeia(USP). U.S. Bio-Technologies Inc.'s Quality Control
testing is performed in strict compliance with current Good
Manufacturing Practices(cGMP) with complete documentation and
quality assurance. Each serum product tested must fulfill or
exceed the expectations of U.S. Bio-Technologies Inc.'s test
parameters before being released for sale. |
|
| ph is measured utilizing standard techniques
at 25? for hydrogen ion concentration. A specific ph range characterizes
each product. |
| Osmolality is determined by freezing point depression
analysis and expressed as milliOsmoles/kilogram of water(mOsm/kg). |
| Sterility is satisfied according to the methods
described in the Code of Federal Regulations(CFR) Title 9, Part
113.26 and the United States Pharmacopoeia XXIII. |
| Mycoplasma testing is by both the direct (or
large volume) method of Barile, CFR Title 9, part 113.28 and
the indirect DNA staining technique using Hoechst(bisbenzamide)
stain. |
| Bacteriophage is determined by plaque assay
using host sensitive strains of E. coli. |
| Endotoxin levels are assayed using the Limulus
Amoebocyte Lysate(LAL) gel clot method and reported in nanograms
per milliliter(ng/ml). |
| Hemoglobin concentration in the serum is determined
by a colorimetric assay and results documented in milligrams
per deciliter(mg/dl). |
| Biochemistries are routinely performed on all
batches of sera, by multiple assays using automated clinical
analyzers, to provide a characteristic profile. |
| Electrophorectic identity profile is characterized
for age and species and is quantified for albumin and globulin
factions as percentages of the total protein. |
| Total Protein is also determined spectrophotometrically
at 540nm by the Biuret colorimetric method and expressed in
grams per deciliter(g/dl). |
| Growth promoting performance of sera is assessed
measuring effectiveness in cell culture systems, including diploid
cell line, through several (three or more) subcultures to eliminate
any carryover residual effects from the stock medium previously
used. The cells are observed for evidence of nutritional deficiency,
cytotoxicity and other morphological aberrations indicating
the presence of toxic components. Such performance is measured
using a constant inoculum and permitting growth over a period
of time and the increase in cell number is determined. The growth
promoting performance is measured in comparison with a validated
reference control. |
|
| This assay determines the capacity of the test
serum to support the attachment and the growth of adherent cell
culture systems. The adherent continuous cell line used for
this assay is chosen for its sensitivity to small variations
in the serum. Reduces inoculum size is used to provide for clone
development. This assay is performed for a duration of 10-12
days. Plating efficiency of test serum is compared with a validated
reference control. |
| Cloning efficiency demonstrates the ability
of sera to promote proliferation of clones from very low inocula
and is selectively important for supporting growth and cloning
capabilities of myeloma cellsand resultant hydridomas. Ninety-six(96)?well
plates are used for this procedure, the incubation time is 10-15
days and the results are reported as a percentage compared with
a validated reference control. |
|
| Absence of adventitious viruses is confirmed
in accordance with modified CFR Title 9, Part 113.53: |
| Bovine species derived sera are tested for the
presence of Bovine Viral Diarrhea virus(BVD), Infectious Bovine
Rhinotracheitis(IBR) and Parainfluenza virus Type 3(PI 3) by
both florescent antibody for cytopathogenic effects(CPE). Positive
controls are prepared in parallel with these tests.
Ubiquitous presence of BVE virus in bovine
sera has been recognized for many years as a problem particularly
for those engaged in production of human and animal vaccines.
Additionally, the presence of antibodies to
BVE in bovine sera are determined.
|
| Horse Serum is tested for the presence of Equine
Infectious Anaemia(EIA) by the Coggins tests. EIA exists worldwide
and is even endemic in some areas. Transportation of infected
horses is restricted as the mode of transmission of EIA is by
biting insects. Only EIA seronegative horse blood is processed. |
|
| Porcine serum and porcine derived products used
as components of cell culture are tested for the presence of
Porcine Parvovirus(PPV). PPV is a very stable virus, is readily
transmissible and even survives the process used to prepare
porcine trypsin.
*ANY SERUM EXHIBITING THE PRESENCE OF ANY OF THESE SPECIFIC
VIRUSES IS REJECTED AND WILL NOT BE INCORPORATED INTO ANY
U. S.. BIO-TECHNOLOGIES, INC.'S SERUM POOLS.
There is no known Bovine Spongiform Encephalopathy(BSE)
in the USA. The United States has been free from foot and
mouth disease and swine vesicular disease for the past 2 year;
it has been free from rinderpest, peste des petits ruminants,
contagious bovine pleuropneumonia, lumpy skin disease, rift
valley fever, sheep pox, African swine fever for the past
3 years; it has been free from bovine spongiform encephalopathy
for the past 5 years. There has not been any vaccination against
any of the above diseases.
|
Fetal Bovine Serum - (Samples available
upon request)
1) "US ORIGIN" Premium Quality Fetal Bovine Serum
2) "USDA ORIGIN" Premium Quality Fetal Bovine Serum
Serum included in this category has
been taken from its country of origin via the USA, where it
is virus tested and approved by the United States Department
of Agriculture(USDA). Prior to the manufacturing of USDA serum,
U.S. Bio-Technologies, Inc. checks with all health regulatory
agencies of each country of origin.
Primarily this category includes serum from
Australia and Mexico.
Serum Treatments
Heat Inactivation - Fetal Bovine Serum is heat-inactivated
by a thermostatically controlled procedure at 56? over 30
minutes.
Dialization - For this purpose, the Fetal Bovine
Serum is dialyzed against physiological saline until a glucose-level
of 10 mg/? is reached. The cut-off of the membrane is at 10,000
Dalton.
Embryonic Stem Cells Pretested - This type
of Fetal Bovine Serum supports the growth of undifferentiated
colonies of ES-cells. This application is recommended for
many types of primary cells, but is very limited. Approximately
2-3 batches of this serum are produced per year. The reserve
period is strictly held to a period of 6 weeks from the time
samples are received. |
Newborn Bovine Serum Age: 3-7 days old
Bovine Calf Serum Age: 6-9 months old
Adult Bovine Serum Age: Greater than 1 year old |
Horse Serum
Donor Horse Serum
Porcine Serum
Rabbit Serum
Goat Serum
Lamb Serum
Chicken Serum
Guinea Pig Serum
Rat Serum
Mouse Serum
Hamster Serum
Dog Serum *Additional variety
of other animal serum is available upon request.
|
|
1) Human Serum "Off the Clot"
Human Serum "Off the Clot" is processed from blood
collected in single-use blood bags without any anticoagulant.
After natural clotting, the blood is stored overnight at +4?
to allow full clot retraction. It is then centrifuged, the serum
collected into a satellite bag and then frozen at -20?.
2) Human Serum "Converted"
Human Serum "Converted" is processed from human
plasma to which calcium chloride and thrombin solutions are
added in excess. After the removal of the clotted plasma,
the "converted" serum is pooled.
Note : Human Serum "Converted" is
generally slightly cloudy, especially after freezing and thawing
due to the conversion process from plasma.
Reagents
U.S. Bio-Technologies Inc. provides a range of the most frequently
used cell culture reagents.
All reagents are manufactured under strictly
controlled conditions using pretested raw materials from approved
sources.
Liquid solutions are sterile filtered down
to 0.2? and dispensed into sterile PETG bottles under laminar
air flow.
1) G-418
2) Trypsin
*Additional reagents are available upon
request.
|
