#USA #Avid Bioservices #Costa Mesa #Early Phase Center

Avid Bioservices Unveils New Early Phase Center in Costa Mesa

Avid Bioservices, Inc., a leading contract development and manufacturing organization (CDMO) specializing in biologics, has officially opened its latest facility, the Early Phase Center of Excellence, located in Costa Mesa, California. This state-of-the-art center spans 78,000 square feet and is meticulously designed to support early clinical programs, significantly expanding Avid’s developmental capabilities.

Facility Purpose and Design

The Early Phase Center will facilitate and streamline early drug development processes, ensuring a smoother transition from early clinical trials to full-scale commercial manufacturing. This innovative facility combines Avid’s core scientific and technical expertise, providing comprehensive services that include:

• - Cell Line Development
• - Upstream and Downstream Process Development
• - IND Enabling Analytical Methods
• - Early Formulation Development and Testing
• - Integrated Technology Transfer to cGMP Facilities

This center is strategically crafted to enhance the efficiency of Avid's operations, supporting a collaborative environment for clients, and maximizing the potential for successful outcomes in their developmental programs.

Responding to Industry Needs

In his opening remarks, Kenneth Bilenberg, CEO of Avid Bioservices, emphasized the importance of this facility as a response to industry demands for a U.S.-based manufacturing and development powerhouse. 'Our new Early-Phase Center of Excellence is tailored to help both established pharmaceutical companies and innovative biotech firms expedite their transition to clinics in a predictable manner, ensuring quality and stability throughout the process,' he stated. Avid's mission is clear: to bolster early drug development efforts across the U.S., moving swiftly from scientific innovation to tangible patient benefits.

The facility is equipped with experienced personnel trained in both scientific inquiry and manufacturing processes. Established workflows and harmonized quality systems are in place, safeguarding consistency and facilitating a seamless advancement of programs from preclinical stages through to commercial supply.

Expansion of Capabilities

This new center is set to significantly bolster Avid's capacity to manage a broad array of biologics, including monoclonal antibodies, recombinant proteins, and complex therapeutic modalities. By optimizing integrated workflows and leveraging advanced technology platforms, the Early Phase Center aims to minimize project risks, shorten timelines, and guarantee that development is appropriately aligned with various phase requirements right from the onset.

Fully operational now, Avid's Early Phase Center is prepared to accept new programs, further enhancing its reputation and capabilities within the biopharmaceutical industry.

About Avid Bioservices

Avid Bioservices operates as a global CDMO focused on mammalian cell-culture manufacturing. Based in the United States with an impeccable FDA record, Avid is a trusted partner for biopharmaceutical innovators worldwide, recognized for its adaptability, commitment to quality, and adeptness at navigating complex regulatory environments. The company’s extensive experience spans collaborations with both emerging biotech enterprises and established multinational pharmaceutical corporations, offering end-to-end solutions starting from development and extending through to commercial supply.

Avid by the Numbers:

• - Over 600 batches manufactured
• - Beyond 275 commercial batches dispatched globally
• - 6+ approved commercial products
• - Successful pre-approval inspections from various global regulatory agencies

The opening of the Early Phase Center underscores Avid’s dedication to supporting innovative biopharmaceutical initiatives, ensuring that scientific advancements can swiftly transition into impactful health solutions.