22 Mar Top Contract Manufacturer for Exosomes
Are you looking for a contract manufacturer for your exosome product? If so, then Bello Bio is your best exosome contract manufacturing option.
Bello Bio of Scottsdale, Arizona is FDA registered. The tissue processing lab is ISO Certified to ISO 7 standards. But actually, the lab uses real time monitoring and operates to ISO 5 standards. There are two cleanrooms with Level 2 Biosafety cabinets, CO2 incubators and a top of the line Bioreactor. Lab tours are encouraged.
Bello Bio is fully cGMP, which stands for current Good Manufacturing Practices. This means ALL of the reagents, products, etc are GMP Certified. There are no animal reagents used in processing. Even if there is only ONE cGMP reagent available globally for a particular product and it costs 10 times more than a non-cGMP brand, Bello Bio uses it. No cutting corners!
To get started, contact Bello Bio today for a free consultation at (888) 598-0909.
When it comes to manufacturing exosomes, there are several key steps that should be taken to ensure a top of the line product. Culturing mesenchymal stem cells with first rate cells is critical, and then properly sequestering the supernatant is vital to ensuring high counts of exosomes.
Bello Bio utilizes umbilical cord tissue, and uses flow cytometry to analyze for first rate mesenchymal stem cells. The only way to truly achieve the highest numbers of exosomes is to use a bioreactor, and Bello Bio has a Terumo top of the line piece of equipment.
Along with utilizing a bioreactor, Bello Bio also implements tangential flow filtration. This concentrates the exosomes dramatically, and then Bello Bio’s PhD’s use a Nanosight to make sure the exosome counts exceed 20 billion per cc for quality control.
For more information or to speak with one of our experienced specialists, call now at (888) 598-0909.
Whether you are seeking contract manufacturing for liquid exosomes or lyophilized exosomes, Bello Bio can help you. The lab is able to white label your products and use either plastic cryovials or glass. We have graphic designers to assist with labeling, and it can be either black and white or full color.
There are significant requirements the FDA has in place for exosome labeling, inserts, IFU, Certificate of Analysis, and tissue tracking to meet requirements. Bello Bio’s contract manufacturing includes ALL of these necessities to make it easy for you to get all the product needed. Bello Bio can ship to you for warehousing, or can drop ship to your clients if desired as well!
When it comes to donor selection, screening and tracking for umbilical cord tissue, Bello Bio has a quality assurance program that is replicable and thoroughly reviewed prior to batch release. A third party screens the products for communicable diseases, endotoxin, bacteria, virus, fungus as required by the FDA. A Medical Director reviews all the data prior to release.
For your extracellular vesicle contract manufacturing needs, Bello Bio is your best option!
Lab tours are encouraged. Schedule yours today at info@bello.bio or call us at (888) 598-0909.
Bello Bio is a multi-national tissue processing lab focused on research, clinical and contract manufacturing of umbilical cord tissue allografts. Our labs in the USA and Pakistan are ISO Certified, cGMP Compliant and fully registered with the FDA and DRAP.
Call today for any of your allograft needs!
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