At Biotest Pharmaceuticals, our advantage is the flexibility to produce antibody products that exceed the quality criteria demanded by our customers and our stringent regulatory environment. The company effectively identifies, collects, produces and supplies quality antibody products using our network of FDA licensed Plasma Centers, laboratory operations and integrated logistical computer systems.
EXTENDING AUTOMATION TO OUR CUSTOMERS
The Electronic Shipment Information (ESI) file is available to our customers as part of our product package. The ESI contains each unit's test record history, including donor number, donation date and unit volume. This feature reduces data entry and expedites the product processing.
PARTNERING FOR QUALITY AND SAFETY
In addition to the standard serology tests performed on each unit (HIV, HBV and HCV), we have partnered with our customers and as a result, most of our donor population is currently screened by Nucleic Amplification Testing (NAT) or Polymerase Chain Reaction (PCR) methodology. We also perform additional testings in accordance with customer requirements.
EFFECTIVE MANAGEMENT OF OUR PLASMA DONORS
Our Donor Management System (DMS) is a proactive approach that ensures the Company's compliance with current Good Manufacturing Procedures (cGMP), enhances product quality and assists in the management of our plasma donors and their donations in our Plasma Centers.
System capabilities include:
- Automated Lookback Program
- Automated Product Titer Management
- Automated Product Packaging and Shipment
- Continuous Donor and Unit Suitability Assessment
This automated electronic system is FDA 510k cleared and is tailored to meet the industry's continually evolving requirements, along with those of our customers. The system has been successfully implemented at our Plasma centers since the end of 2000.
- We specialize in customized products.
- Proprietary Anti-D Stimulation and high titer program.
- Geographically situated plasma collection centers allow high volume collection programs.
- We pride ourselves on being the industry leader providing high quality products, on-time delivery and specified titer strength.
