Medical Products Supplies Companies

995 Park Center Drive, 92081 Vista, CA
USA
Telephone +1 760 931-8444
info@accessbiologicals.com

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02 Laboratory Technology
02.24 Other laboratory equipment

Other laboratory equipment

IVD Products
Cell Culture Products

Our products

Product category: Other laboratory equipment
IVD Products
FOR IVD MANUFACTURERS
Access Biologicals has built a reputation for providing a comprehensive portfolio of diagnostic sera, plasma-derived reagents and strategic services tailored to meet our customers’ needs.

Disease State Plasma & Serum
Human Blood Products
Processed Serum Production
Analytical Testing

Product category: Other laboratory equipment
Cell Culture Products
Human AB Serum
Access Cell Culture, a division of Access Biologicals, is the only company to directly collect and process human AB serum at FDA-licensed facilities located in the US.
Collections are IRB approved
Donors sign consents and are screened for compliance to 21CFR 640
Full FDA viral testing
Lot sizes from 1L to 500L available.
Available with Human Thrombin.

Human AB Serum: Converted
Our human serum is collected from donors meeting the health requirements established by 21CFR 640, subpart G via plasmapharesis. These individual units are converted to serum and then pooled, filtered, bottled and cell culture tested for mycoplasma, endotoxin, and USP sterility. Each individual unit is tested and found negative for all required viral markers via FDA-approved methods as well as HTLV I/II and West Nile Virus.

Human AB Serum: Off the Clot
Our Off the Clot AB serum is collected from healthy male donors in the United States at FDA licensed facilities. It has been allowed to coagulate naturally and contains no anticoagulants or preservatives.

Human AB Serum Heat-Inactivated
Our heat inactivation protocol brings the temperature of the material to 56° C and maintains this temperature for 30 minutes. Some precipitate may be evident, which can be removed by filtration, if desired.

Animal Sera Products
Access Cell Culture offers a variety of animal sera collected under strict USDA protocols.
As a member of the International Serum Industry Association (ISIA), we pride ourselves on full traceability and products of consistent quality.

Fetal Bovine Serum
Collected aseptically at USDA licensed facilities, produced under cGMP guidelines in an ISO certified, FDA licensed facility.
Each lot is fully traceable by collection date/location and is 9CFR 113.53 tested.
Triple 0.1 µm filtered, Endotoxin <10 EU/mL, Mycoplasma negative, low IgG.
Lot sizes up to 2,000 Liters.

Mouse Serum
Collected from healthy mice of the KM strain in China.
0.2 µm filtered, Mycoplasma, sterility and virus tested.
No preservatives added.

Donor Horse Serum
Collected from controlled donor herds located in the USA.
0.2 µm filtered, Mycoplasma, sterility and virus tested.

Calf Serum
Collected from calves less than 12 months old.
0.1 µm filtered, sterility, Mycoplasma, 9CFR 113.53 & virus tested.
Manufactured under cGMP guidelines in an FDA licensed facility.

Human AB Serum (lot A18049)
Human AB Serum is the serum of choice for work involving human cells: Tissue Engineering, Transplantation of T Cells & Cell therapy applications

Fetal Bovine Serum USDA (lot A18051)

Fetal Bovine Serum US (lot A18045)
Collected aseptically at USDA licensed facilities, produced under cGMP guidelines in an ISO certified, FDA licensed facility. Triple 0.1 µm filtered, Endotoxin <10 EU/mL, Mycoplasma negative, low IgG.

Donor Horse Serum (lot A18064)
Collected from controlled donor herds located in the USA. 0.2 µm filtered, Mycoplasma, sterility and virus tested.

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About Us

Company details
A leader in the collection & manufacture of human biological products, ACCESS BIOLOGICALS LLC supports in-vitro diagnostic manufacturing, biopharmaceutical and Life Science businesses. Comprised of donor recruitment, >50,000 plasma donations, manufacturing operations, cell culture products and clinical study collections these business elements provide a closed-loop supply of the highest quality biological products with total traceability.

Our Company History
Founded in 2006, Access Biologicals quickly established itself in the diagnostic and life science industries as a reliable and consistent source of high quality plasma and serum products. Subsequent acquisitions of strategic industry providers coupled with targeted expansion has allowed Access Biologicals to continue to anticipate and meet the needs of our customers. Starting in 2008, the company established manufacturing, analytical testing and cell culture divisions to further enrich the closed-loop response to our customers’ needs.

Our Business Divisions
Access Biologicals LLC is comprised of business divisions that provide a comprehensive closed-loop response to our customers’ product requirements.

Access Plasma – plasma donation center, which includes collection and donor recruitment
Access Biologicals – processed plasma and serum manufacturing, sales and marketing
Access Cell Culture – portfolio of quality human and animal sera.

Locations
Our headquarters, manufacturing facility and comprehensive donor recruitment office is located in Vista, CA. Sales offices are located in Dartmouth, MA, Atlanta, GA and Philadelphia, PA. Saturn Biomedical, our state-of-the-art plasma and blood collection center in Indianapolis, IN, is uniquely positioned as the largest and newest specialty donor center in the United States.

FDA/CLIA/ISO licenses

FDA Registration # 307234900 – Access Manufacturing
FDA Registration # 3006118943 – Access Biologicals
CLIA Certification ID # 15D0891286 – Access Plasma dba Saturn Bio
FDA License # 1193 – Access Plasma dba Saturn Bio
ISO 9001 Certified

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