A finished batch of medicine can’t go anywhere until someone proves it’s clean. Under the standard sterility method in the U.S. Pharmacopeia, that proof takes two weeks. Technicians put samples into growth media, incubate them for 14 days and then look at the containers by eye for cloudiness, the sign that something is growing. The long incubation exists for a reason. Some organisms grow slowly, and the method has to give them time to show up. Until that inspection is done, the batch sits in quarantine.
For decades, that wait was simply part of the job. Sapho Bio, the San Carlos, California company Abraham Chaibi co-founded with John McSpedon, sums up its pitch in a single line: “Sterility testing results in 2 days.” Its RNA-based test returns an answer in about 20 hours.
The company’s mission statement puts the goal broadly. “We believe pharmaceutical release testing should match the speed and precision of modern medicine,” it reads. The faster test is what the company is known for. What Chaibi is actually building is broader, and he describes it plainly. “Our objective is to automate third-party testing,” he said.
Why regulated products need an outside check
Third-party testing is the independent work that sits between making a regulated product and selling it. Before a drug, a medical device or plenty of other technologies reach the public, someone has to demonstrate that they meet specifications.
Chaibi explains the logic in a sentence. “There’s so many new technologies now, and they can be dangerous,” he said, so regulators want proof that each product does what it’s supposed to do and nothing it isn’t. Pharmaceuticals are an obvious case. He also points to phones and self-driving cars, products that are useful and can still hurt people if something goes wrong.
Much of the testing itself is slow and heavily manual. Chaibi has spent his career on exactly that kind of problem, the work people do by hand over and over because nobody has built a system to do it for them. Before Sapho, he automated NFL schedule creation as an operations engineer, automated petabytes of file transfers at LiveRamp and spent eight years as co-founder and CTO of Dexterity Capital, a high-frequency trading firm whose systems ran research thousands of times a day. In each job the question was whether code could take that work over.
The difference at Sapho is that the work involves living organisms and lab instruments instead of spreadsheets and order books.
A sterility test built around RNA
Sapho started with lot release, the testing a batch has to pass before it can ship. The company needed a faster sterility test to make that work, so it built one. “For lot release testing, which was our original product, we developed a new kind of sterility test, which was able to unblock this,” Chaibi said.
The method looks for RNA. Living bacteria and fungi make RNA constantly, so detecting it is a way to find organisms that are alive in a sample, the ones that matter for sterility. Sapho uses reverse transcription quantitative PCR, or RT-qPCR, which converts RNA into DNA and amplifies it until it can be measured. Nobody has to watch a container for cloudiness.
Two design choices shaped the product. The first was to build on equipment labs already own. Sapho’s brand materials describe it as a platform that “works with your existing qPCR equipment,” and the company says its approach needs no proprietary hardware. The second was to meet the industry’s own bar for new methods. USP<1223> sets out how a lab proves that an alternative microbiological method performs at least as well as the traditional one. In April 2026, Sapho announced that its assay had completed that validation, showing accuracy, precision and a defined limit of detection across hundreds of samples. The same announcement disclosed $5 million in new funding.
The lab delivers certificates of analysis for its rapid sterility service in as little as two business days. By the company’s count, testing through Sapho has saved customers more than 10,000 days in total compared with the traditional method.
A faster test is only useful if a quality team trusts it enough to release product on its result. When the validation was announced, McSpedon’s point was that every test leaving the lab is statistically non-inferior to the 14-day method. For a manufacturer weighing a switch, that comparison with the old method is likely to be the first question.
Speed matters most for products that don’t keep. Cell therapies, biologics and other patient-specific products can have short shelf lives. Sapho’s own materials put it bluntly. “Every hour in quarantine is an hour of usable product life lost.” For a therapy made for a single patient, a two-week hold can eat a large share of the time that product is usable at all.
From one test to a testing menu
A single fast test doesn’t automate an industry. Sapho’s lab now runs a menu of release and quality tests, most of them on a two-business-day turnaround. Alongside rapid sterility, the list includes:
- Endotoxin testing under USP<85>
- Potency testing under USP<621>
- Container closure integrity testing under USP<1207>, using a vacuum decay method
- Particle counting, visual inspection, fill volume and pH testing
Each answers a different question about a batch. Endotoxin testing looks for fragments of bacterial cell walls, which can cause fever and other reactions if injected even when no living bacteria remain, so a product can pass sterility and still fail here. Container closure integrity testing checks the package rather than the drug. In the vacuum decay method, a sealed container goes into a test chamber under vacuum, and any rise in pressure points to a leak that could let contamination in after the product has shipped.
It also offers slower work where the standards require it. A traditional compendial sterility test under USP<71> takes 18 calendar days, antimicrobial effectiveness testing takes 30 business days, and stability studies start at $10,000. The lab’s ISO/IEC 17025 accreditation assessment is scheduled for the fourth quarter of 2026.
A manufacturer that needs a batch released usually needs several tests, not one, and a lab that can run them together saves it from coordinating between vendors.
Chaibi describes the compounding effect of that work. Every time Sapho solves a testing problem, the solution stays with the team, and “we’re able to more and more quickly solve these kinds of problems,” he said. The first version of a test is slow to build. The tenth similar one goes much faster.
That model has carried the company to 30 enterprise customers, and its lab now handles thousands of tests a month.
Software that moves things
Abraham Chaibi has automated a lot of things over the years, and he says this platform is different in one way. Early in his career, automation lived inside computers, because physical equipment was so much harder to control. He calls the change a “huge unlock.” Code can now drive lab instruments directly. At Sapho, the team writes custom software for its machines as a matter of routine, work that would once have taken weeks.
Sapho’s team reflects that mix of lab science and systems work. McSpedon, the CTO, was the first employee at the AI technology group Merantix and has worked in protein materials and metagenomics. The company’s operations research scientist, Cameron Bravo, spent 15 years as a particle physicist and contributed to equipment at CERN. Its research scientists include Santhosh Karanth, who has a decade of assay development experience, and Ali Palla, who holds a biochemistry PhD from UCSF and has worked in RNA biology.
The company lists “Love to Read” and “Own and Ship” among its core values, which fits its CEO. Chaibi reads widely and loves science. Before he ever worked in trading, he did laser research at South Africa’s Council for Scientific and Industrial Research and designed a leak-warning circuit at the Princeton Plasma Physics Laboratory.
What comes next
One product in development would move the test into customers’ own labs. The company is working on a GMP-ready sterility testing kit based on the same technology, meant for manufacturers that want to run rapid testing in-house rather than send samples out. Sending samples to an outside lab means packaging, shipping and waiting on a report. A validated kit would let the same test run down the hall, on qPCR machines the manufacturer probably already has. The company describes the broader plan as “a rapid microbiology release platform for precision medicine, starting with sterility testing and expanding across multiple applications.”
That is a lot of ground to cover, and Chaibi has a view on how to cover it without losing focus. Everyone in his market is under pressure to move quickly, customers included. His rule is to keep “a clear purpose, a clear reason that you’re doing what you’re doing,” and then to “identify the thing that you need to deliver” before spreading effort across everything at once.
At Sapho, the first thing was a 14-day wait. Abraham Chaibi’s bet is that the rest of third-party testing has plenty more waits like it, and that each one his team clears makes the next one easier.
