BIOLYPH collects the information required to understand your company's requirements for reagent formulation and device so we may apply our experience, technology, and services to meet your specific needs.
The first step in achieving successfully lyophilized reagents is to optimize their formulation for lyophilization. The excipients serve to protect your reagents from the variety of in-process production stresses it will encounter.
Based on your specific formulation, BIOLYPH prepares excipients which serve to uniformly suspend your particles, protect your active ingredients from the lyophilization process, and optimize their complete rehydration and reactivation.
To create LyoSpheres™, BIOLYPH dispenses your solutions in aliquots ranging from 15 µL to 250 µL (generally less than 2% CV).
This is when lyophilization temperature, pressure, and time cycle requirements are established. These parameters affect the sensitivity and thoroughness of the lyophilization process.
BIOLYPH has developed cycles for meeting the needs of various reagent types and volumes.
Lyophilization is BIOLYPH's core competency.
BIOLYPH produces batches ranging from 1 to 1,000,000+ LyoSpheres.
Handling lyophilized reagents outside of an operational lyophilizer is virtually impossible without compromising the quality and performance of a properly lyophilized reagent.
BIOLYPH has innovated a solution to this our specialized packaging suites, which operate at below 3% relative humidity.
See our LyoSpheres page for examples of devices in which LyoSpheres are packaged.
BIOLYPH utilizes a variety of production documents that detail and track the processing of your products from receipt to shipment.
In support of our Clients who produce class regulated products, we model our Quality Systems after FDA and ISO requirements for In Vitro medical devices.
BIOLYPH's Quality Policy "Through training, communication and ongoing improvements, we strive to exceed our Client's expectations for quality, stability, consistency, value, and on-time delivery."
BIOLYPH has extensive experience assisting our Clients with optimizing the design and utility of their proprietary devices for the housing and rehydration of their lyophilized reagents. Our focus is to help you store the LyoSpheres in an atmospherically safe fashion, present the rehydration fluid properly, and allow mixing for their final use.