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From donation to finished product

Human-based biologicals company offers closed loop

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Plasma is the single largest component of human blood, and it's the essential starting point for a range of medicines. As such, its collection and subsequent change into new life-saving materials is an integral piece of the biomedical field -- and San Marcos-based Access Biologicals LLC plays its own important role.

While those in the traditional consumer goods arena may find it strange to label human plasma a "product," it is just that. Access Biologicals' product list includes human-based products such as disease-state plasma and serums as well as the manufactured products from plasmas. And these are sold in a way similar to more traditional business products as well. For instance, albumin (largely used to treat patients who have endured trauma, severe burns, or major surgery) is sold in either a powder or liquid selection. The manufacturing unit produces human serum, which is derived from plasma and can be provided in nearly any custom form requested. The markets for these products are primarily biopharmaceutical, in-vitro diagnostic manufacturing and diagnostic research and development.

The company's donor recruitment offices and production facility are located in San Marcos, and it oversees a donation facility in Carlsbad. Overall, it uses a "closed-loop" approach: from the recruitment of donors, to the collection of the plasma or serum, to the laboratory testing, to the final manufacturing of products from these materials.

Access Biologicals' manufacturing facility, Access Manufacturing, is itself a closed-loop system as well. That is, it controls both the starting biological materials, which are collected and screened internally, as well as the manufacturing stemming from those materials. Many facilities today also manufacture and store products created from animal materials, but Access Manufacturing does not.

Donations of plasma have long stemmed from the stereotypical college student on a shoestring budget, but individuals of all types can and do donate. Locally, Access Biologicals' trained donor recruiters oversee donations such as the specialty donor and anthrax donor programs. Donors are paid or volunteer, and they are screened both verbally and physically to comply with the FDA's regulations. Access Biologicals notes that each product is traceable back to the donor, with age, gender and other information available at buyer request.

The company also encourages doctors to identify their patients who might be eligible for one of the specialty antibody programs, which seeks individuals who've received positive diagnosis for certain conditions; in turn, their donations are those that can act as a control supply. Also, in addition to its own donor center, Access Biologicals works with other plasma donor centers across the country, and in turn has access to roughly 8 million plasma collections.

According to the Plasma Protein Therapeutics Association, 20 million liters of plasma are used worldwide every year to manufacture plasma protein therapies for patients with a range of deficiencies and disorders. In the United States, donations have been steadily increasing over the past few years, with more than 15 million source plasma donations in 2007 -- perhaps signaling welcome positive growth potential for both this industry and the patients it ultimately serves.

Blackford is a Los Angeles-based freelance writer.

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