Manufacturers with the skill, willingness, and production capacity to make small, custom batches of cell culture and process liquid solutions are hard to find. Many manufacturers don’t make the smaller batches needed for clinical trials, can’t meet cGMP requirements, or simply lack the manufacturing capacity.
“That leaves a segment of companies with nowhere to go,” says Justin Henson, executive vice president–chief strategy and marketing officer, GeminiBio. Henson politely stops there, but he leaves no doubt that “small batch” and “custom batch” companies should see GeminiBio as a good destination. GeminiBio’s customers include academic laboratories and biotechnology companies, as well as large manufacturers that outsource production of some of their smaller or more complex cell culture and process liquid products.
“Our focus is on liquids,” says Brian Parker, who recently joined the company as CEO. “We’ve recently reorganized to bring clarity around our two verticals: cell culture solutions and process liquid solutions.
“For process liquid solutions, customers require material manufactured under cGMP conditions and in batch sizes ranging from 10 to 1,000 L. During Q3 2022, we are scheduled to be able to scale to 10,000-L batches.”
The cell culture solutions business offers fetal bovine and human serums as well as the Orflo Moxi family of cell analyzers. “Importantly, our animal-origin-free manufacturing operations are located in separate facilities,” Parker notes. “They are more than a block away from our animal-origin manufacturing facilities.” This physical segregation minimizes the risk of cross-contamination.
Serum solutions and instrumentation
One of GeminiBio’s most recent cell culture solutions products is GemCell Plus Xeno-Free Human Serum, which is developed from healthy male AB serotype donors in the United States. The product is manufactured without using bovine materials.
The company plans to continue to build out its human serum solutions with ancillary products that work alongside human serum, such as human platelet lysates, growth factors, and cytokines. Parker adds that the company plans to offer “both research-use-only and cGMP-grade products to help customers meet regulatory demands as they grow toward commercialization.”
GeminiBio expanded into cell analysis instruments by acquiring Orflo Technologies in 2019. At the time, Orflo’s marquee products were the Moxi Z cell counter and Moxi Go benchtop flow cytometer. Recently, GeminiBio launched—for research use only—the Moxi V for precise, plug-and-play cell counting and viability applications. The company claims that the Moxi V is between 50 and 100 times more sensitive than vision counters, accurately counting cells as small as 3 µm, in concentrations low as 10 cells/µL. It can count 23,000 cells in less than 15 seconds.
“The Moxi Go II, however, is the most exciting,” Henson remarks. “It puts multiple capabilities into one portable, less expensive instrument that performs as well as two standalone instruments.”
“Customers who use it need to monitor cell viability and cell count, as well as size, GFP expression, CD phenotyping, etc.,” Parker details. Various combinations of those capabilities reside in other Moxi family members. For example, the Moxi Z detects the size and number of cells, whereas the Moxi V adds a laser to detect cell viability.
Because the Moxi Go II combines these capabilities, it is more flexible, a quality valued by cell therapy developers, especially those working with chimeric antigen receptor T cells. “Previously, customers have had to use two relatively large, rather expensive instruments,” Henson points out. With the Moxi Go II, he continues, samples needn’t be prepared twice, and certain maintenance requirements can be eliminated.
Staking out a leadership position
“We’re small, but we’re growing significantly,” Parker states. “We’re not necessarily a leader in the human serum market, but we’re looking to take the lead. In fetal bovine serum, we’re a historic player, though not a large one. We differentiate ourselves by being agile and enabling scalable solutions that simplify our customers’ workflows.”
With respect to process liquids, the company aims to stake out a leadership position around providing scalable, cGMP-compliant manufacturing of custom solutions. Soon, these will range not just from 10 L to 10,000 L, but from 10 L to 10,000 L. “Not a lot of companies can do that,” Henson observes.
GeminiBio, like a startup company, is driven to build a leadership position by addressing customers’ unmet needs. “In some respects, GeminiBio is a 35-year-old startup,” Henson suggests. “As our customers evolved, we evolved.” And the company is growing quickly. “We built a new 25,000-square-foot cGMP facility in 2020 during the height of the pandemic,” Henson says. “And we are building out into a third facility to meet additional demand.”
Contributing to market stability
In 1985, Bert Polan founded the company in Calabasas, CA, to remove the volatility around the market for fetal bovine serum, which was directly affected by the price of cattle. “A drought that made cattlemen thin their herds could cause a glut of serum that season and a shortage the next,” Henson explains. (A similar situation occurred in human serum. During COVID-19, people were less likely to donate plasma, thus making human serum and platelet lysates less available.)
“Bert carved out a niche in what was somewhat of a commodity market,” Henson relates. “If a customer had a need, he found or created a way to fill that need. That philosophy is still the core of the company.”
Because GeminiBio manufactures its products in the United States, it has avoided some of the COVID-19-triggered supply chain shortages that have affected many in the biotechnology industry. Also, GeminiBio’s proximity to customers has translated into lower shipping costs and shorter delivery timelines.
GeminiBio plans to continue growing its process liquid and cell culture product lines. For example, the company is working to add lysates and other differentiated products. GeminiBio also plans to continue expanding its custom manufacturing capabilities.
“Part of our vision is to solve customers’ pain points when making process liquids for upstream and downstream use,” Henson explains. “Eventually, we may explore the manufacture of trusted weight dry powders for customers for whom a liquid product simply isn’t the best solution to their non-core manufacturing needs. We’d like to explore salts aliquoted to certain sizes to support plug-and-play operations, so customers could use them without the need to weigh or test them.”