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

Avid Bioservices Launches New Early Phase Center

In a significant move to bolster its capabilities in the biopharmaceutical sector, Avid Bioservices, Inc. has officially opened its new Early Phase Center of Excellence in Costa Mesa, California. This advanced facility spans 78,000 square feet and is dedicated to supporting early clinical developments. The establishment of the center marks a pivotal expansion of Avid's operational presence in the market.

The Early Phase Center of Excellence is engineered to streamline and enhance the development timelines for clients by merging essential scientific and technical expertise within Avid. This includes various critical services:

• - Cell Line Development: Crafting high-performance cell lines that serve as the backbone of biotherapeutics.
• - Process Development: Tailoring upstream and downstream processes to optimize yields and quality.
• - Analytical Method Qualification: Ensuring processes meet industry standards through IND-compliant validations.
• - Formulation Development: Early-stage formulation efforts aimed at maximizing drug stability and effectiveness.
• - Integrated Technology Transfer: Seamlessly transferring developed technologies to Avid’s CGMP production facilities for scale-up.

Kenneth Bilenberg, the CEO of Avid Bioservices, highlighted the objective behind this modern facility: “Our new Early Phase Center of Excellence is specifically designed to assist established pharma companies and innovative biotech firms in entering clinical phases much faster, based on reliability and quality. Our mission is to enhance early drug development in the U.S., expediting the journey from scientific discovery to patient impact.”

This facility not only aims to support the needs of its clients but also addresses a recognized gap within the industry for a development and manufacturing center that brings together speed, quality, and scientific rigor within the United States.

Moreover, the Costa Mesa expansion has amplified Avid’s overall capacity to cater to a broad spectrum of biologic products, encompassing monoclonal antibodies, recombinant proteins, and other intricate modalities. By establishing integrated workflows and technological platforms, Avid aims to mitigate program-related risks, curtail timelines, and secure phased development from the very initial stages.

Fully operational, the Early Phase Center is now welcoming new programs with the promise of providing a comprehensive suite of end-to-end services, showcasing Avid's robust dedication to quality and innovation in drug development.

About Avid Bioservices

Avid Bioservices stands as a globally recognized contract development and manufacturing organization (CDMO), primarily focusing on mammalian cell culture processes. With its headquarters in the U.S., Avid maintains an impeccable record with the FDA and has earned the trust of biopharmaceutical innovators worldwide, thanks to its agility and expertise in navigating complex regulatory landscapes. Whether it’s supporting budding biotech firms or major multinational pharmaceutical entities, Avid provides seamless end-to-end solutions, ensuring quality from development through to commercial delivery.

Key Statistics

• - More than 600 batches manufactured.
• - Over 275 commercial batches delivered across 90 countries.
• - 6+ approved commercial products.
• - Successfully passed 10 advance audits from global regulatory agencies.

With this significant development, Avid Bioservices continues to lead the charge in the biopharmaceutical ecosystem, ensuring that they meet the ever-evolving demands of their clients with unwavering quality and efficiency.