High Volume hMSCs
A: Our human mesenchymal stem/stromal cells (hMSCs) are provided at a population doubling level (PDL) of 8-10 post-mononuclear isolation (Bone Marrow; Equivalent Passage 2) or 14-18 post-isolation from the perivascular region of Wharton’s Jelly (Umbilical Cord; Equivalent Passage 3). Due to variabilities of seeding and harvest densities we characterize our MSC “True Age” in terms of their PDL.
A: There is no need to feed cells between passages. Our media is engineered to be a batch culture media, where no media exchange or feed is necessary when following our suggested protocols.
A: No, we do not pool donors at any time during our production. Master Cell Banks (MCBs) are created from each donor source. Working Cell Banks (WCBs) are produced from our MCBs for general product sales.
A: We characterize our hMSCs by following ISCT criteria: cell identity (surface marker expression), functional potency (angiogenic cytokine and IDO secretion), and trilineage differentiation (adipo-, osteo-, and chondrogenesis). This information is provided to allow customers to choose the optimal hMSC tissue type and donor for their specific application or target indication.
A: We perform industry leading characterization of our hMSCs at time points post product to best analyze the customer experience.
A: Our hUC Working Cell Banks are sold at a starting population doubling level (PDL) of 14-18, and we recommend using the cells by a PDL of ~26 to maintain functional traits (Equivalent Passage 5).
A: RoosterBio’s hBM Ready-to-Print product line offers pre-expanded hMSCs which are at PDL ~16 (Equivalent Passage 4) for thaw and use applications. If you have more specific needs, please contact us to further discuss a customized solution.
A: Our cells are manufactured using standardized manufacturing platforms, resulting in high-volume product formats that are well-characterized, robust, and reproducible. With the lowest cost per million cells, our ready-to-use scalable products support a commercially viable path to clinic and market in a fraction of the time.
A: Our serum containing cells are exposed to animal-derived products, such as Fetal Bovine Serum, in the medium. Our Xeno-Free cells are not exposed to animal-derived components at any point during production, storage, or use.
A: We offer adult human mesenchymal stem/stromal cells (hMSCs) to propel the commercialization of regenerative technologies. These products are available in Research Grade (RUO), Xeno-Free (XF) Development Grade, and XF Clinical Grade (cGMP) CliniControl™ formats.
A: As part of our manufacturing process, we use BioLife Solutions CryoStor5 Freeze Media for cell cryopreservation, but any standardized cryopreservation technique would be applicable.
A: Both hBM-MSCs and hUC-MSCs should be stored immediately in liquid nitrogen, vapor phase. We do not recommend storage at -80C.
A: We do not recommend any surface coatings for use with our cell systems. Our serum containing hMSCs and media work well with any standard TC-treated plates. We do, however, highly recommend Corning CellBind™ surfaces to provide enhanced attachment for our Xeno-free hMSC and media systems.
A: Yes, this high-affinity surface is highly recommended for use with our XF product line.
A: RoosterNourish™-MSC (KT-001) is a traditional (serum-containing) medium. RoosterNourish-MSC-XF (KT-016) and RoosterNourish-MSC-CC (KT-021) are Xeno-Free media.
A: RoosterBooster-MSC (serum-containing) and -MSC-XF (Xeno-Free) are components which when combined with RoosterBasal™-MSC make up our RoosterNourish-MSC (KT-001) and RoosterNourish-MSC-XF (KT-016) complete bioprocess media, respectively.
A: RoosterBio cells are compatible in other media systems, but results may vary. It is strongly recommended to implement the RoosterBio media system (cell + media), which our cells are isolated in, for most repeatable and robust performance.
A: We do not sell media specifically for differentiation, and RoosterNourish is specifically engineered for expansion only.
A: Our RoosterBooster-MSC, RoosterBooster-MSC-XF and RoosterReplenish-MSC-XF supplements are not recommended for repeated thaw and freeze cycles. We cannot guarantee their effectiveness if aliquoted.
A: No, our media does not contain any antibiotics. We do not use antibiotics internally nor do we recommend their use. However, we realize that every workflow and environment is different and is, ultimately, a customer choice.
A: No, RoosterNourish-MSC-XF (KT-016) is a bioprocess medium developed for use in both 2D and 3D cell culture configurations. RoosterReplenish-MSC-XF (SU-023) is our concentrated bioreactor feed for use in a fed-batch 3D bioreactor process that enhances media productivity and circumvents the need for a ½ or full media exchange.
A: Our bioreactor bioprocess media system (RoosterNourish™-MSC-XF, KT-016; RoosterReplenishTM-MSC-XF, SU-023) has been tested in multiple bioreactor systems and provides flexibility for integration into your process flow. We can provide full support and recommendations for integrating these products into your system.
A: RoosterBio can supply information pertaining to our current donor available and assist customers in donor selection.
A: Our XF Bioreactor Starter Bundle (KT-056), XF Bioreactor Development Bundle (KT-057), and XF Bioreactor Scale-Up Bundle (KT-058) are supplied with recommended expansion protocols. Prior to scale-up to the 3L scale (KT-058), contact our bioreactor technical experts. We recommend Corning® Low Concentration Synthemax™ II Microcarriers (not included in kits) and can provide recommendations for alternative microcarrier types. Please contact us for technical expertise or more information.
Process Development Services
A: Yes, at RoosterBio, we utilize our strong foundation with stem cell manufacturing and application to provide custom services to fit our clients’ needs in MSC and EV therapy. Please reach out to our Process Development Services to discuss what RoosterBio can do to help accelerate your process.
A: RoosterBio has expertise in process design, process development capabilities with project infrastructure, and management to accelerate projects. The scope of those projects will help determine the timeframe, which can range from weeks to months.
A: Yes, we provide analytics services to further characterize custom products or our current products. Our Process Development Services can provide more information.
Buying & Shipping
A: RoosterBio products can be purchased directly through our website or via PO/Invoice system. We accept both credit card and PO for payment on website. We also accept US and international direct wire transfer.
A: Cells are shipped either by dry ice or LN2 Dewar. Media components are shipped on dry ice, unfrozen in ice packs, or at room temperature depending on product.