Healthcare manufacturers are well aware of the importance of microbiological testing to ensure their product's safety and efficacy. The constant threat of product or plant contamination requires ongoing vigilance.
At AAIPharma we can provide you with the microbiological expertise developed over almost 30 years in serving the biotech, pharmaceutical and medical device industries. At AAIPharma, we not only perform this testing for our customers, but as a contract manufacturer, we perform the testing ourselves on products we make for our customers. This truly differentiates us from those who only test on behalf of 3rd parties. This also keeps us on the leading edge of global compliance standards as we constantly upgrade our capabilities to meet the increasing needs of our global customer base. The strictest attention to every detail ensures the performance of the methods used to test and/or monitor the conditions of your GMP manufacturing environment and the quality of products produced. Our capabilities enable you to free resources to focus on internal programs as we become an extension of your organization. We offer a wide range of compendial and non-compendial testing services. Our core strengths include disinfectant qualification, antibiotic assays, non-sterile product evaluation (microbial limits testing) and sterile product testing including barrier isolation technology.
Our services include:
Technical definition and protocol generation
Method development and method validation
Testing of formulations, Active Pharmaceutical Ingredients (APIs) and excipients; finished products; in-process and stability samples
Flexible service arrangements customized to your methodologies
Support for new products from concept to filing
Consulting services to guide testing needs based on relevant regulations
Troubleshooting of product or in-plant contamination problems
Our Microbiology Laboratory in Wilmington, N.C., also has extensive experience in the evaluation of contamination of down-stream (purification) processes for the biotechnology industry and in the evaluation of column storage solutions for effective microbial control. Evaluation of these processes has been crucial for improved contamination control of biotechnology-derived products.
We offer fast turn around times, competitive pricing and excellent customer service. We have a fully staffed and experienced laboratory operation to serve your testing needs.
