Mammalian cell culture drug substance manufacturing & lab expansion

Facility expansion increases manufacturing capacity

Avid Bioservices, a leading biopharmaceutical CDMO, partnered with CRB on the design to expand the manufacturing capabilities at its existing Myford facility located in Tustin, California. The goal for this expansion, Drug Substance Line 3 (DS 3), was to augment Myford’s existing Drug Substance Line 2 (DS 2) to meet the surging demand for mammalian cell culture production of clinical and commercial biologics in the market, reaffirming the client’s commitment to being a trusted partner for delivering innovative and high-quality biopharmaceuticals.

The project not only involved increasing manufacturing capacity but also encompassed several critical components. These components include quality control labs, standardizing equipment platforms, walkable ceilings, warehouse reconfiguration, loading dock expansion, and the construction of a new central utilities plant.

Enhancing bioprocessing capabilities while de-risking operations

Designed to process up to 20kg of bulk protein per batch, DS 3 is one of the largest fully disposable, CGMP cell culture manufacturing suites in California. From start to finish, the production process utilizes a variety of single-use technologies, including single-use bioreactors (SUBs), single-use mixers, and tubing sets, which eliminates the risk of cross-contamination.  This capacity expansion project includes the build-out of a ballroom design for SUBs in the upstream area supported by two identical harvest downstream processing suites. Additionally, the media and buffer prep suites are integrated within the cleanroom space creating safe and efficient operations for the manufacturing formulation employees.

The SUBs in DS 3 include 3 x 100L, 3 x 500L, and 6 x 2,000L systems. All bioreactors at Avid Bioservices, spanning from process development to DS 2 and DS 3, employ identical hardware, control systems, and bag designs. This uniformity aims to enhance not only process reproducibility but also streamline operator training and vendor management programs. These versatile bioreactors increase manufacturing flexibility and enable Avid Bioservices to meet diverse production requirements. For instance, they can use a 100L SUB for small-scale production or combine multiple 2,000L SUBs (multiplexing) for large-scale commercial projects.

Modular cleanroom technology for flexible and quality manufacturing

The facility integrates approximately 33,000 square feet of prefabricated modular cleanroom panels from AES technology, creating ISO 7/8 cleanroom space. The facility layout prioritized a functional and efficient interior, strategically placing rooms and processes to minimize personnel, production, and material movement. The use of prefabricated modular panels for the cleanrooms represents an innovative design approach to ensure optimal manufacturing conditions. This underscores the client’s commitment to upholding the highest cleanliness standards and rapid delivery of space to the market.

Central utilities plant to enhance infrastructure and reliability

In addition to the capacity expansion, the Myford facility integrated a central utilities plant. This plant includes a 1,000-ton chiller plant, two microbulk tanks for process gases, backup generators, and hot water boilers. The design and installation of these utilities incorporate N+1 redundancy, considering equipment maintenance. This ensures the Myford facility’s capability for continuous 24/7, 365-day operation—an essential aspect to accommodate heightened production needs and provide comprehensive facility support.

The finished facility

The final facility is purpose-built with cutting-edge, single-use technologies and backed by redundant utilities. Its design facilitates clinical and commercial biologics production, providing over 20,000L of single-use bioreactor capacity to meet current market demands. Drug Substance Line 3 advances the client’s vision to be a dependable and trusted partner for biologics development and manufacturing services.