About BioLife Solutions

BioLife Solutions, Inc. operates as a life sciences company. The company develops, manufactures, and markets bioproduction tools and services, which are designed to improve quality and de-risk biologic manufacturing, storage, distribution, and transportation in the cell and gene therapy (‘CGT’) industry and broader biopharma markets. The company’s products are used in basic and applied research and commercial manufacturing of biologic-based therapies. Customers use the company’s products to maintain the health and function of biologic material during sourcing, manufacturing, storage, and distribution. The company operates as one bioproduction tools and services business, which supports several steps in the biologic material manufacturing and delivery process. The company has a diversified portfolio of tools and services that focuses on biopreservation, cell processing, frozen biologic storage products and services, cold-chain transportation, and thawing of biologic materials. The company has in-house expertise in cryobiology and continues to capitalize on opportunities to maximize the value of the company’s product platform for its extensive customer base through both organic growth innovations and acquisitions. The company offers products that integrate into the critical steps of preservation, thawing, fixed storage, and transportable storage under controlled conditions. Products The company’s bioproduction tools and services are consisted of three revenue lines that contain seven main offerings: cell processing (biopreservation media and human platelet lysate media (‘hPL’), cryogenic vials, and automated cell-processing fill machines); freezers and thaw systems (ultra-low temperature freezers, cryogenic freezers and accessories, and automated thawing devices); and storage and cold chain services (biological and pharmaceutical material storage, and cloud connected ‘smart’ shipping containers). Cell Processing Biopreservation Media The company’s proprietary biopreservation media products, HypoThermosol FRS and CryoStor, are formulated to mitigate preservation-induced, delayed-onset cell damage and death, which result when cells and tissues are subjected to reduced temperatures. The company’s technology can provide its CGT customers with significant shelf-life extension of biologic source material and final cell products and can also greatly improve post-preservation cell and tissue viability and function. The company’s biopreservation media are serum-free, protein-free, fully defined, and manufactured under current Good Manufacturing Practices (cGMP). The company strives to source wherever possible, the highest available grade, multi-compendium raw materials. The company estimates its cell processing products have been incorporated in nearly 700 customer clinical applications, including numerous chimeric antigen receptor (CAR) T cell and other cell types. The company’s scientific research activities over the last 20+ years enabled a detailed understanding of the molecular basis for the hypothermic and cryogenic (low-temperature induced) damage/destruction of cells through apoptosis and necrosis. This research led directly to the development of the company’s HypoThermosol FRS and CryoStor technologies. The company’s proprietary biopreservation media products are specifically formulated to minimize cell and tissue swelling; reduce free radical levels upon formation; maintain appropriate low temperature ionic balances; provide regenerative, high-energy substrates to stimulate recovery upon warming; avoid the creation of an acidic state (acidosis); and inhibit the onset of apoptosis and necrosis. A key feature of the company’s biopreservation media products is their ‘fully-defined’ profile. All of the company’s cGMP products are serum-free, protein-free and are formulated and filled using aseptic processing. The company strives to use USP/Multicompendial grade or the highest quality available synthetic components. All of these features benefit prospective customers by facilitating the qualification process required to incorporate the company’s products into their regulatory filings. The company’s CryoStor formulations incorporate multiple permeating and non-permeating cryoprotectant agents, which allow for multiple mechanisms of protection and reduces the dependence on a single cryoprotectant. The results of independent testing demonstrate that the company’s biopreservation media products significantly extend shelf-life and improve cell and tissue post-thaw viability and function. The company’s products have demonstrated improved biopreservation outcomes, including greatly extended shelf-life and post-thaw viability, across a broad array of cell and tissue types. Human Platelet Lysate Media, Cryogenic Vials and Automated Cell-Processing Fill Machines In September 2021, the company acquired Sexton Biotechnologies, Inc. (‘Sexton’), a producer of bioproduction tools. Sexton's bioproduction tools portfolio includes human platelet lysates for cell expansion, which reduces risk and improves downstream performance over fetal bovine serum, human serum, and other chemically defined media, CellSeal closed system vials that are purpose-built rigid containers used in CGT that can be filled manually or with high throughput systems, and automated cell processing machines that bring multiple processes traditionally performed by manual techniques under a higher level of control to protect therapies from loss or contamination. Freezers and Thaw Systems Ultra-low Temperature Freezers In May 2021, the company acquired Global Cooling, Inc. (‘Global Cooling’), a manufacturer of class defining ultra-low temperature freezers. Global Cooling carries a portfolio of freezers that range in size from portable units to stationary upright freezers to accommodate a wide variety of use cases. Users can configure these freezers to achieve temperatures between -20°C and -86°C. The portfolio was designed to be environmentally friendly and energy efficient, using as little as 2.8 kWh/day at temperatures of -80°C. The freezers do not use compressor-based or cascade refrigeration systems. Instead, they use patented free-piston Stirling engine technology that uses fewer moving parts. Cryogenic Freezers and Accessories The company’s line of cryogenic freezers offer leading design and manufacture of state-of-the-art liquid nitrogen laboratory freezers, cryogenic equipment and accessories. The company’s Isothermal LN2 freezers are constructed with a patented system, which stores liquid nitrogen in a jacketed space in the walls of the freezer. This dry storage method eliminates liquid nitrogen contact with stored specimens, reduces the risk of cross-contamination, and provides increased user safety in a laboratory setting. To accommodate customer requirements, the company offers customizable features, including wide bodied and extended height models. The company’s high-capacity controlled rate freezers (‘HCFR’) are designed for large volume storage with customizable freezing programs and the ability to monitor conditions in real time. To accompany the offerings of cryogenic freezer equipment, the company supplies equipment for storing critically important biological materials. This storage equipment includes upright freezer racks, chest freezer racks, liquid nitrogen freezer racks, canisters/cassettes and frames, as well as laboratory boxes and dividers. Due to the company’s onsite design and manufacturing capability, racks and canisters can be customized to address customers’ varying requirements. Automated Thawing Devices The ThawSTAR line includes automated vial and cryobag thawing products that control the heat and timing of the thawing process of biologic material. The company’s customizable, automated, water-free thawing products use algorithmic programmed heating plates to consistently bring biologic material from a frozen state to a liquid state in a controlled and consistent manner. This helps reduce damage during the temperature transition. The ThawSTAR products can also reduce risk of contamination versus using a traditional water bath. Storage and Cold Chain Services Biological and Pharmaceutical Storage In October 2020, the company acquired SciSafe Holdings, Inc. (‘SciSafe’), a premier provider of biological and pharmaceutical storage. In addition to providing storage services, SciSafe provides cold chain logistics that ensures materials are kept at target temperatures from the moment that the materials leave the customer’s premises to their ultimate return. Monitoring systems employed by SciSafe allow for customers to monitor the storage temperatures of their materials throughout the entire logistics chain. The company operates six storage facilities in the U.S.A. and one facility in the Netherlands. Cloud Connected ‘Smart’ Shipping Containers The company is a leading developer and supplier of next generation cold chain management tools for cell and gene therapies. The company’s cloud-connected shipping containers and evo.is cloud app allows biologic products to be traced and tracked in real time. The company’s evo platform consists of rentable cloud-connected shippers that include technologies enabling tracking software to provide real-time information on geolocation, payload temperature, ambient temperature, tilt of shipper, humidity, altitude, and real-time alerts when a shipper has been opened. The company’s internally developed evo.is software allows customers to customize alert notifications both in data measurements and user requirements. The evo Dry Vapor Shipper (‘DVS’) is specifically marketed for use with cell and gene therapies. The evo DVS has an improved form factor and ergonomics over the traditional dewar, including extended thermal performance, reduced liquid nitrogen recharge time, improved payload extractors, and ability to maintain temperature for longer periods if tilted on its side. The company utilizes couriers who already have established logistic channels and distribution centers. The company’s strategy greatly reduces the cash need to build out specialized facilities around the world. The company’s partnerships with several white glove couriers allow the company to scale its sales and marketing effort by leveraging their salesforce. The company’s courier partnerships market its evo platform to their existing cell and gene therapy customers as a cost effective and innovative solution. The company also markets directly to its existing and prospective customers who can utilize the evo platform through the company’s courier partnerships. Strategy The company focuses on the development, production, and commercialization of differentiated, best-in-class products and services that facilitate the manufacturing, delivery, and storage of cell and gene therapies and biologic materials. The company’s products are designed to increase its customers’ product yield and the company is committed to supporting its customers with strong customer service and applications expertise. The company leverages its numerous relationships with the leading cell and gene therapy companies that use the company’s expanded product portfolio of bioproduction tools and services to cross-sell the company’s other parts of the portfolio. The company’s products are designed to increase its customers’ product yield and functionality, and the company is committed to supporting its customers with strong customer service and expertise in the clinical applications of the company’s products. Sales and Marketing The company markets and sells its products through direct sales and third-party distribution. The company has experienced field-based sales employees who market its growing product portfolio on a direct basis. The company’s products are also marketed and distributed by STEMCELL Technologies, MilliporeSigma, VWR, part of Avantor, Thermo Fisher and several other regional distributors under non-exclusive agreements. Product Regulatory Status To support the company’s prospective clinical customers, the company manufactures and releases its products in compliance with cGMP and other relevant quality standards. To assist customers with their regulatory applications, the company maintains Type II Master Files at the FDA for CryoStor, HypoThermosol FRS, BloodStor 27, Stemulate, nLiven PR, T-Liven PR, CellSeal Closed System Cryogenic Vials, and the company’s Cell Thawing Media products, which provide the FDA with information regarding the company’s manufacturing facility and process, its quality system, stability and safety, and any additional testing that has been performed. A group of isothermal, standard, and carousel LN2 freezers in the company’s freezers and thaw systems product line is regulated as Class 2 medical devices in the EU. History BioLife Solutions, Inc. was founded in 1987. The company was incorporated in Delaware in 1987.