
|

|
We have established our technology leadership position through research, development, and design activities coupled with a substantial investment in manufacturing technologies and equipment. The return on this investment has come in the form of improved productivity, quality, yields, and throughput and also insights that have led to new products and features. For example, the development of our
gene-based therapeutics arose from our recognition of the need for a more
efficient process of immunizing the populations that do not respond to the
prophylactic vaccines or are increasingly resistant to conventional
pharmaceutical based treatments.
We've successfully maintained our leadership position through multiple technological transitions in the
prophylactic and therapeutic vaccine development. We've accomplished this by staying on the leading edge of product and process development and continuing to excel at our core competencies.
Development Center
Process and product development work is done in a state-of-the-art Development Center located
within our AT-GC divisions. By focusing product and process development work at this dedicated center, we are able to test and tune processes and designs before they transition to high-volume production. Through the efforts of our Development Center, we have shortened our
drug development cycles and accelerated transitions to high-volume production. The benefit to our customers is faster time-to-market which is the key to profitability in the
biopharmaceutical industry.
Product Development
We strive to deliver product solutions that help our customers reduce costs, improve efficiencies, and address their unique and rapidly changing
product quality requirements. We link our product development efforts with those of our customers' through close working relationships as well as through joint development agreements.
Through our joint development efforts, we gain an understanding of personalized
medicine technology trends and technical issues. We develop product concepts which can be customized to meet the needs of specific customer
drug development applications.
Process Development
Our products require several manufacturing processes, each dependent on different technical disciplines, to ensure the high degree of precision and process control necessary to meet tight customer tolerances and other requirements. We have developed proprietary manufacturing processes and controls and related equipment which are essential to the precision and reliability of our products. We continuously focus on providing leading-edge process capability. Our manufacturing processes include:
- Quality by Design manufacturing
-
Molecular fingerprinting
-
Endotoxin and bioburden management
-
real time analytics
We monitor and control these processes through real-time statistical process analysis to track critical parameters and take corrective action as required.
our process development is optimized for manufacturing products with consistent
quality-fast and reliably.
|

|