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Our Services
Excipient Formulation The first step in achieving successfully lyophilized reagents is to ensure that the solutions have been optimally formulated for lyophilization. The excipient or matrix serves to protect the reagent from the variety of in-process production stresses it will encounter. BIOLYPH is very experienced at optimizing excipients for our clients’ reagents. Cycle Development This is the step in which lyophilization temperature and time cycle requirements are established. These parameters affect the sensitivity and thoroughness of how well our clients’ reagents are stabilized. BIOLYPH has developed a comprehensive variety of cycle parameters dependent on the reagent, dispense volume, batch size, etc. Dispensing In order to create LyoSpheres™, BIOLYPH dispenses each client’s reagents at the precise volume required (generally less than 2% CV). LyoSpheres™ can be dispensed in aliquots ranging from 13 µL to 250 µL. If more volume per device is required, multiple LyoSpheres™ can easily be packaged inside a single device. BIOLYPH is in the process of developing the equipment and processes required to dispense aliquots from 1 µL to 12 µL with great precision. Lyophilization Lyophilization is BIOLYPH’s passion and core competency. BIOLYPH has created equipment and procedural innovations which optimize all of the steps required to yield successfully stabilized reagents. BIOLYPH produces batches ranging from 1 to 1,000,000+ LyoSpheres™. BIOLYPH maintains a minimum of 50% more lyophilization capacity than is required to meet our clients’ annual requirements. This ensures unexpected production demands can be promptly satisfied. Packaging Handling lyophilized reagents outside of an operational lyophilizer is almost impossible to do without compromising the quality and performance of a properly lyophilized reagent. All handling of our clients’ lyophilized reagents is performed inside packaging suites operating at below 2% relative humidity (RH). BIOLYPH has created and continues to innovate the equipment and processes required to package and seal LyoSpheres™ inside whatever type of reaction device is best suited for our clients’ products. Documentation BIOLYPH is capable of meeting whatever level of procedural and documentation requirements our clients specify. BIOLYPH has created a variety of documents it utilizes from the beginning of each client relationship. These include, but are not limited to:
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