#USA #Avid Bioservices #Costa Mesa #CDMO #Biologics

Avid Bioservices Opens New Early Phase Center

Avid Bioservices, Inc., a leading Contract Development and Manufacturing Organization (CDMO) specializing in biologics, has officially inaugurated its state-of-the-art Early Phase Center of Excellence in Costa Mesa, California. This expansive facility spans 78,000 square feet and is meticulously designed to support early clinical programs. This strategic expansion reinforces Avid's commitment to enhancing its development capabilities while allowing it to offer comprehensive end-to-end services—from cell line development to commercial manufacturing.

Facility Features and Capabilities

The new center serves as a crucial resource aimed at expediting the development timelines for clients. It houses Avid's core scientific and technical capabilities, which include:

• - Cell Line Development
• - Process and Analytical Development (both upstream and downstream)
• - IND-enabling Qualification and Analytical Method Testing
• - Early Formulation Development and Characterization
• - Technology Transfer aligned with Avid's cGMP manufacturing facilities

This innovative center is strategically designed to streamline early development activities, ensuring a seamless transition to large-scale, cGMP operations. The facility is staffed with experienced scientific teams and manufacturing personnel, employing established platform processes and quality systems that align seamlessly with Avid’s commercial manufacturing facility. This alignment not only guarantees consistency but also minimizes rework, enabling a smooth progression of programs from preclinical phases to commercial supply.

Commitment to Accelerating Drug Development

Kenneth Bilenberg, the President and CEO of Avid Bioservices, stated, "Our new Early Phase Center of Excellence is crafted to enable established pharmaceutical companies and innovative biotech firms to enter clinical stages swiftly and predictably, focusing on quality and stability. Our mission is to elevate early drug development in the U.S., accelerating the journey from scientific discovery to patient impact.” This facility is part of Avid's response to industry demands for a U.S.-based development and manufacturing hub that embodies speed, quality, and scientific rigor.

As a result of this expansion, Avid is now better equipped to support a wide range of biological products, including monoclonal antibodies, recombinant proteins, and other complex modalities. The integrated workflows and technological platforms within the center aim to mitigate program risks, shorten timelines, and ensure proper development right from the initial phases.

Operational Launch and Future Endeavors

The Early Phase Center of Excellence is now fully operational and ready to accept new programs from clients. Avid Bioservices has solidified its reputation as a trusted partner for biopharmaceutical innovators worldwide, attributing its reliability to agility, quality service, and the ability to navigate complex global regulatory landscapes.

Avid’s track record speaks volumes:

• - Over 600 manufactured batches
• - 275 commercial batches delivered across 90+ countries
• - 6 approved commercial products
• - 10 successful pre-approval/license inspections from global regulatory agencies

This facility's launch marks a significant advancement in Avid’s operational capacity, aligning with the company's commitment to support biotechnology firms in their quest to bring groundbreaking therapies to market efficiently and effectively. The new center signifies Avid’s dedication to filling the existing gaps in early-phase drug development in the biopharmaceutical industry, ultimately leading to better patient outcomes across the globe.