The first phase of the expansion project will add up to seven cleanroom suites for large-scale autologous and allogeneic cell therapy production, says Cellipont.

Cellipont Bioservices, previously known as Performance Cell Manufacturing, has expanded rapidly since its acquisition by private equity firm Great Point Partners earlier this year.

In May, the San Diego-based contract development and manufacturing organization (CDMO) announced plans to expand cell therapy development and manufacturing capabilities at its Poway, California facility, and now Cellipont is planning a 76,000 square-foot commercial-ready plant in The Woodlands, Texas.

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“The facility is being designed for the manufacture of cell therapies and gene-modified cell therapies utilizing the latest analytical equipment for in-process and release of mid-to-late phase and commercial clinical products,” CEO Deborah Wild told BioProcess Insider.

“The [undisclosed] investment will focus on quality, safety, and technology. We will be designing a facility that meets and exceeds industry and regulatory standards of the US, Europe and other world markets. Our technology investment will focus on larger scale cell quantities for autologous and allogeneic therapies. This will include new innovative technologies in manufacturing and also critical quality control assays.”

The facility will be equipped with process improvement products such as cGMP pre-packaged liquid/powder media, incoming patient material processing equipment such as apheresis, and downstream fill/finish technologies that are faster and improve safety and ultimately lower cost of goods, she continued.

“The purchase of equipment will be based on cell therapy workflows: Cell Preparation, Cell Washing, Cell selection, Electroporation, Expansion, Harvest, formulation, and filling. Since the type of cells, processes and amount of cells needed can determine what equipment is needed, we will be flexible on the technologies we will use. Cellipont will strive to develop fully-closed automated processes in order to reduce costs and reduce risk of contamination using equipment from Miltenyi, Cytiva, Wilson Wolf, Terumo and other leaders in the industry.”

Cellipont will undertake a phased approach to the facility buildout with up to seven large, single-pass air, cleanroom suites for multi-product/multi-line production set to come online in the first half of 2023.

“A phased approach allows us to meet the needs of our clients for capacity in the quickest way possible. Our second phase design will include additional cleanroom capacity and will be designed to meet the specific production needs of our strategic partners.”

California and Texas

The facility, located in cell and gene therapy hub Houston, will work hand-in-hand with the Poway plant, currently undergoing an expansion to increase capacity for process development and Phase I/II programs.

“The redundancy between sites offers a business continuity strategy that our clients need to ensure that if one site is at capacity or a testing device is down, we have backup,” said Wild. “It also provides an expansion plan to bridge their growth requirements. The redundancy also means that we can transfer tests and processes between sites with the same quality system, manufacturing staff, training programs and other like-for-like aspects to ensure reproducibility of the client’s process.”

She added the Poway facility will focus on process/analytical development and early phase cell therapy manufacturing. “We will also have development capacity at The Woodlands facility to aid in tech transfer but also offer customers additional development capacity. The Woodlands facility will be Cellipont’s headquarters as well as its flagship for commercial manufacturing.”