RoosterBio Launches New cGMP Stem Cell Product Portfolio, Maintaining Unwavering Commitment to Driving the Explosive Regenerative Medicine Industry

RoosterBio Inc, today, proudly announces the launch of its CliniControl™ (CC) product portfolio, clinically-relevant starting and ancillary materials that generate unprecedented efficiencies in adult stem cell manufacturing, accelerating clinical translation of human Mesenchymal Stem/Stromal Cell (hMSC)-based therapies. The CliniControl product portfolio will radically simplify major steps in product development and clinical translation, improving the likelihood of commercial success for RoosterBio customers.

The first in the CliniControl line of products, RoosterNourish™-MSC-CC bioprocess medium sets the new standard of industry-leading performance. RoosterNourish-MSC-CC is a first-in-class, standardized, xeno-free (XF) bioprocess medium engineered to support not only 2D (plastic adherent), but also 3D suspension culture of hMSCs in allogeneic and autologous therapeutic manufacturing. Formulated specifically for clinical research process and product developers, RoosterNourish-MSC-CC yields superior media productivity, leading to drastically reduced cost of goods as compared to other hMSC culture media. The highly productive RoosterNourish medium is designed for batch 2D and fed-batch 3D cultures and seamlessly translates between culture platforms enabling scalable hMSC culture, delivering robust, reproducible and standardized results at a commercially-viable cost of goods.

RoosterBio CliniControl bioprocess media are manufactured with methods and controls that conform with current good manufacturing practices (cGMP) for medical devices, 21 CFR Part 820 and will be supported by Quality documentation that significantly reduces customer time spent preparing investigational new drug (IND) submissions. CliniControl products are analogous to RoosterBio’s Development Grade (RUO) products, but adhere to more stringent quality regulations appropriate for their intended use. RoosterBio’s Quality Assurance Team is committed to providing the highest quality products in compliance with applicable regulatory requirements to satisfy customers’ needs and meet or exceed their expectations.

Of the new product portfolio, Director of Business Development and Strategic Marketing, Dr. Priya Baraniak said: “RoosterBio was founded on the…

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