USP and ISO Extractables & Biocompatibility Testing Underway for Single-Use Biopharmaceutical Containers & Tubing

We have initiated coordinated extractables and biocompatibility testing on our Tubing and Container products used in biopharmaceutical fluid processing and single-use applications. We contracted with a leading institute to coordinate independent extractables and biocompatibility testing, according to current industry standards and practices. These include USP <665> and USP Class VI, as well as ISO 10993 and BPOG Extractables protocols.

Product Under Test Include:

• CellGyn^™ TPE Tubing – manufactured by TBL Performance Plastics
• PharmaTainer^™ PET or in Polycarbonate containers – manufactured by CELLON S.A
• Altimed^™ Platinum-Cured Silicone Tubing – manufactured by Silicone Altimex
• Pharm-A-Clear^™ Platinum-Cured Silicone Tubing – manufactured by TBL Performance Plastics

PRESS RELEASE:

Camarillo, CA, August 2020 - CTS Bioprocessing (“CTS”), a leading vertically-integrated player in the single-use bioprocessing technology space, is pleased to announce the acquisition of Sani-Tech West, Inc. (Sani-Tech West & subsidiaries SaniSure^® and SureTech, together “STW”). Founded in 1991 and headquartered in Camarillo California, STW designs, develops, and manufactures single-use solutions for the bioprocessing industry including customized bottle assemblies, aseptic transfer systems, caps, flasks, tubes, and clamps. The business has c. 170 employees and operates two facilities in Southern California. STW has longstanding customer relationships with leading biopharma and biotech customers, exhibiting an impressive reputation for high-quality solutions and customer service. In addition to its assembly offerings, STW provides customers several unique, IP-backed manufactured solutions to address customers’ unique applications.

The combined CTS and SaniSure^® platform creates a strong operational footprint across North America and Europe, enabling the company to serve customers on a more global basis. With vertically integrated manufacturing & assembly operations in both North America and Europe, the business can offer its customers enhanced supply chain assurance for a combined portfolio of leading solutions, supported by a leading network of global distribution partners. Together, CTS and STW will offer its customers leading solutions for critical fluid path technologies, including PharmaTainer^™ bottles & carboys, Cap2v8^® solutions, aSURE^® fittings, Bio-Ease^™ clamps, Mixed4Sure closed Carboy Mixing system, Gama stable stir bars together with a wide range of extrusion capabilities of silicone tubing and other elastomeric solutions such as the Cellgyn^® TPE tubing.

As part of the combination, the group is changing the parent company name from CTS BioProcessing to SaniSure^®. However, each of the Cellon, TBL, Silicone Altimex and the Sani-Tech West companies will continue to utilize existing brand and trade names.

Richard Fry, founder and CEO of Cellon, commented: “The addition of Sani-Tech West to the CTS platform is very exciting. Their capabilities and product portfolio are highly complementary to those of CTS. Additionally, their strong North American presence will enable the combined organization to better serve the needs of our customers on a more global basis, including bringing more PharmaTainer™ based products & assemblies to North American customers.”

Richard Shor, founder and CEO of Sani-Tech West, said: “We are excited to work with 3i and the CTS team. We have a shared vision for the future, which was critical to our decision to join the group. Together, our expanded portfolio of innovative product offerings, extensive design & manufacturing capabilities, and our broadened geographic footprint will help us to become an even stronger partner to our customers.”

Bob DuPont, CEO, TBL, said: “We are delighted to welcome Sani-Tech West to the CTS platform. We have known Richard Shor and his team for quite some time and there is a strong cultural fit between our organizations. We are excited to offer additional capabilities and supply chain assurance to our partners, and our collective resources will enable us to further shorten lead times and strengthen our quality leadership position.”

The company will continue to experience strong growth supporting key customers in the fast-growing biologics market, and in particular, customers working on the development and commercialization of monoclonal antibody, vaccine, and cell and gene therapy modalities with single-use technologies in a variety of upstream and downstream applications.