Fill and finish is the final step in biopharmaceutical production, where a purified drug substance is converted into its final, patient-ready dosage form under sterile conditions. While many contract service providers offer fill-and-finish solutions for large-scale manufacturing, options for small batches remain limited. White Raven, founded by CEO and co-founder Dimitri Woronoff, aims to respond to this need by providing innovative GMP-compliant aseptic filling services, through an automated solution for small quantities of drug product.
"When I was working for a CDMO in fill and finish, I noticed the lack of services for my clients producing small batches," says Woronoff. "The market was primarily built for large-volume manufacturing. Looking more closely, I realized this wasn't just an occasional issue. It was a structural gap." Recognizing the pain points and the need, he decided to establish White Raven to serve clinical-stage and other small-scale manufacturers.
Simplifying the process
To develop an efficient and cost-effective production process, White Raven took inspiration from large industrial filling lines while eliminating unnecessary complexity.
"Traditional manufacturing plants are highly complex," Woronoff explains. "They require extensive supporting equipment, all of which must be cleaned and sterilized between batches to prevent cross-contamination. Even minor changes to the production schedule can require significant time for verification and coordination."
For high-volume production, lengthy preparation times are acceptable. "If you're filling very large batches, spending 10 to 12 hours preparing equipment for the next run is not a major issue. But when the filling process itself takes only about 30 minutes, it makes little economic sense to spend another 10 to 12 hours cleaning, sterilizing, and preparing the equipment."
Smart design choices
A key design principle was to remove everything from the production process that was not essential. All product-contact equipment is single-use, eliminating the need for cleaning and sterilization after each batch.
"That makes a huge difference," says Woronoff. "We no longer need washing or autoclaving equipment. Because we work with small volumes, mainly for clinical-stage products, and production runs are infrequent, single-use technology is the most practical solution."
White Raven also purchases Water for Injection (WFI) rather than producing it on-site, further reducing equipment requirements and simplifying operations.
Digitalization and robotics
Digitalization has been a priority from the very beginning. White Raven has implemented a largely paperless management system, reducing the risk of human error while improving efficiency.
"It prevents mistakes, such as using the wrong materials during manufacturing, and it speeds up the process," Woronoff says. "We still use some paper documentation in the production area, but almost everything else is digital."
The aseptic filling process itself is performed in a Grade A isolator by robots, removing human intervention and therefore eliminating the biggest risk of contamination. Sensors automatically collect data from equipment throughout production and transfer it directly to the central IT system for continuous monitoring. If a deviation occurs, such as a temperature excursion, the system immediately identifies the affected batches, enabling rapid tracing and isolation. Finishing activities—including labelling, packaging, and preparing products for distribution—are outsourced to a specialized partner.
Expertise
Since 2025, White Raven has been fully compliant with Good Manufacturing Practice (GMP) requirements for manufacturing clinical trial materials and since this year also for commercial material. As demand continues to grow, more companies are turning to White Raven for specialized support.
"Fill and finish requires expertise that differs from the earlier stages of drug manufacturing, especially when it comes to regulatory requirements and the new modalities being developed," Woronoff concludes. "We help our clients navigate those challenges while providing a flexible solution for small-scale production."