Reagent Manufacturing Capabilities
It’s your breakthrough technology, developed to improve lives, and realized through painstaking research, perseverance and resolve. It’s time to move your product forward. For that, you need a partner.
AmBio understands the complexity and business of launching new technologies, as well as supporting current products and product lines. We begin with discovery, assess your needs and goals, work toward deep collaboration, and establish trust. Our common goal is to heighten product quality and performance. This has been our commitment, and why our customers rely on us, year after year, launch after launch, product after product.
Our core capabilities include formulating, filling and finishing with many ancillary supporting resources in place. We plan on using YOUR supply chain so you don't need to revalidate unless you need help with risk strategies or alternate suppliers.
FORMULATING From pilot lots and validation through commercial lots of material, we have the equipment, state of the art water system, facility and personnel to support benchtop small scale manufacturing up to 1200L lot sizes.NO MINIMUM QUANTITIES.
FILLING Capturing your Design Inputs, we will fill containers of your choice whether it is vials, collection tubes, bottles, bags, plates or cartridges. Since we have no minimum batch size, we can do small manual or semi-automated fills all the way up to high speed automation on one of our filling lines. Our automation has application torque and labeling capabilities. We can even autoclave at this point if necessary. Some of our customers choose to manufacture their own product and we are simply dosing. There are many options here that we can discuss with you.
FINISHING After your product is made and filled, we will finish your product in our finished good area. Activities could include shrink banding, heat sealing, kitting, or a number of other finishing activities.
All operations are competed in our ISO 13485:2016 registered facility in Canton, MA. Our Quality Management System is Master Control and together with our ERP system, we have the process and the systems in place to integrate your product seamlessly into our operation.
Have questions? Call Heidi at 508-314-8575 or Stacey at 508-654-1841.
With unwavering commitment, expertise and infrastructure, we fuel and strengthen the life science market with reagent manufacturing services for our visionary partners. As a trusted and reliable resource, our goal is to set the standard for partnership excellence in life science.