ASI and Chemic Laboratories, Inc. recently announced a three year Joint Cooperation Agreement that will enable the two companies to collaborate on a number of product development projects in the pharmaceutical and biopharmaceutical markets particularly in the areas of leachable and extractable analytical data supporting Single-Use Systems (SUS).
Under the terms of this agreement, the two companies can now leverage their collective expertise in polymer film analytics, development and commercial manufacturing to make a positive impact in their client’s business performance. The impacts will be through the reduction of time needed to bring products to market while mitigating risk during the pharmaceutical and biopharmaceutical development process by providing deep comparative studies and extensive polymer profile data.
Carl Martin, Chief Executive Officer for ASI, commented that "Given the need for analytical data within the Life Sciences and Healthcare markets, we are confident that the collaboration with Chemic Laboratories will further enhance the support we provide to our customers. Additionally, this collaboration will facilitate the understanding of SUS in terms of impact and regulatory guidance.”
"Chemic is very pleased to establish this formal working relationship with ASI, which is poised to become a global leader in the area of Single-Use Technology,” said Joseph St. Laurent, President and CSO of Chemic Laboratories Inc. "This Joint Agreement places our two firms at the forefront of the rapidly expanding marketplace of companies that are seeking to further understand their pharmaceutical and biopharmaceutical products and the impact the SUS can have on these processes."
The cooperation model between the two companies will consist of ASI developing film products and SUS systems for use by pharmaceutical and biopharmaceutical customers while Chemic will utilize well established and developed analytics to provide extractable data assessing material compatibility with model bioprocessing solutions as typically employed in pharmaceutical and biopharmaceutical processes. Developing detailed informational packages will allow SUS users to 1) Streamline their processes, 2) Predict material compatibility, and 3) Move directly into leachable, migration and simulation investigations as applicable.
ASI is a leading global provider of advanced single-use systems for the Healthcare and Life Sciences Industries. ASI’s fully customized systems and high-quality services offer the flexibility to maximize efficiencies, minimize costs and alleviate risks in the production of bio-pharmaceutical processes and patient-care devices. ASI’s manufacturing and corporate headquarters are in Pennsylvania, United States with an additional production facility in Matamoros, Mexico. ASI’s ISO Class 7 and ISO Class 8 Clean Rooms are rigorously monitored through in-house Quality Management and Third Party Audits. ASI single-use systems are manufactured in compliance to the ISO 13485:2003 Certification and FDA Regulations.
About Chemic Laboratories, Inc.
Chemic Laboratories is a privately held full service FDA registered and DEA licensed, cGMP/ GLP Contract Chemistry Organization (CCO) founded in 1998. Chemic offers unparalleled contract Analytical, API Synthesis, and Formulation Development, to the Pharmaceutical, Biotech, and Medical Device industries. Chemic Laboratories offers these services by providing a strategically designed, highly technical facility, equipped with state of the art instrumentation. All programs can be conducted under the strict auspices of FDA and EMEA guidelines.
SOURCE: ASI Life Sciences