Medical Products Supplies Companies

37 Birch Street, 01757 Milford, MA
USA
Telephone +1 508 244-6400
Fax +1 508 634-3334
info@seracare.com
http://www.seracare.com

Product Categories

Product categories

02 Laboratory Technology
02.24 Other laboratory equipment

Other laboratory equipment

Controls & Reference Materials
Validation & Qualification Materials
Cell Culture Reagents
Plasma & Serum Diluents & Derivatives

Our products

Product category: Other laboratory equipment
Controls & Reference Materials
Highest-Quality Controls and Reference Materials for Infectious Disease and Genomic Testing
Clinical laboratories require consistent, stable, and reliable sources of materials to validate and monitor their assay’s performance. With increasing reliance on test results and decreasing reimbursement, “gold standard” reference materials and controls are a necessity for any lab to implement a best-in-class quality control program. SeraCare’s trusted controls and reference materials provide:

Patient-like performance for serology, molecular PCR, and sequencing-based assays
Precise titration and high lot-to-lot consistency with excellent signal-to-noise ratio
A wide range of important viral and bacterial pathogens including HIV, HBV and HCV, C.diff, and CT/NG
Highly-multiplexed NGS biosynthetic reference materials for tumor-profiling, cell-free DNA, NIPT, and germline testing

Trusted Brands:

ACCURUN® controls for molecular and serological infectious disease testing
Seraseq™ clinical NGS reference materials for somatic cancer, reproductive health, inherited diseases, and infectious diseases.

SeraCare’s controls and reference materials, along with iQ™ NGS QC Management quality control monitoring software, can aid in improving your quality assurance program while reducing costs from unwanted repeat procedures and saving your staff time in their daily workflow.

Product category: Other laboratory equipment
Validation & Qualification Materials
SeraCare’s validation and qualification materials are the ideal resource to develop, challenge, and confidently validate your assays, verify new lots of reagents, as well as train and evaluate your laboratory personnel. Our materials are thoroughly evaluated and highly characterized for targeted use by IVD manufacturers, clinical laboratories, and academic researchers.

Validation and lot qualification materials from SeraCare include a variety of products to help you meet your unique development and validation requirements. Natural donor samples, disease state panels, and formulated biological materials are readily available with detailed analyte data to help you develop, challenge, troubleshoot, verify, and validate your assays. Enjoy the reliability and experience of a company with a history of providing trusted validation materials to the diagnostic testing industry for over 30 years.

Disease State Panels
SeraCare has been a trusted provider of disease state panels for over 30 years. Assay developers and clinical laboratories worldwide have used our panel products in the ongoing development and validation of their assays. Found in many diagnostic assay package inserts and comparative test kit studies, our panels are a hallmark of our long-standing line of products for serology and molecular applications.

AccuVert™ Seroconversion Panels
AccuSet™ Performance Panels
AccuSpan™ Linearity Panels
AccuTrak™ Qualification Panels

Disease State Specimens
Collected through our worldwide network of sourcing partners, SeraCare offers a diverse, expansive inventory of characterized individual donor specimens. With small aliquots, full bulk units, and custom development services, we have the materials you need to help accelerate your assay development and validation projects.

Our expansive disease state inventory offers a wide array of materials available by disease and analyte type. Each batch and its test data are listed with a detailed certificate of analysis to provide you with the relevant information to confirm the specimens meet your needs.

Viral Isolates

High-titer viral isolates and purified RNA are critical components in the development workflow for infectious disease assays, and for HIV assays, diverse genotypes can be very difficult to find. AccuType™ viral isolates offer IVD manufacturers and clinical laboratories a high quality, high-titer source of material to challenge HIV genotype and viral load assays.

With genotypes spanning both group M and group O, SeraCare’s unique portfolio of HIV isolates offers a rare collection unlikely to be found anywhere else. Paired with our vast inventory of disease state specimens and performance panels, you will have abundant options to select from for genotype materials.

Product category: Other laboratory equipment
Cell Culture Reagents
Sourcing qualified materials to support your cell culture needs can be challenging. Count on SeraCare for a continuous supply of human plasma products with the consistent quality required for drug, vaccine, or diagnostic products. Our Male AB plasma (converted to serum) and human serum albumin (HSA) powders and solutions deliver the quality and reliability you need for cell culture applications.

Human serum albumin (HSA) is offered as diagnostic grade powder or solution formats, as well as therapeutic grade solutions. Various concentrations are available to meet your specific application needs. The human plasma used to produce the material is collected in FDA or EU-licensed facilities and tested on FDA-approved methods.

Male AB Plasma

Male AB plasma is considered an important media supplement for optimal cell culture growth. Our male AB plasma is converted to serum for use in cell culture applications. The human plasma is collected in FDA-licensed facilities and has tested negative for viral markers on FDA-approved methods. The product is sterile filtered and certified negative for mycoplasma and endotoxin.

Human Serum Albumin
HSA is offered in both diagnostic grade and therapeutic grade. Diagnostic-grade HSA is available in both powder and solution formats, while therapeutic grade is provided in solution format. Various concentrations are available to help meet your customized needs.

Product category: Other laboratory equipment
Plasma & Serum Diluents & Derivatives
Searching for critical reagents to expedite development of your assay?

SeraCare offers over 30 years of experience and innovation in the development of reagents for use as diluents in the design of test kit controls and calibrators, cell culture media supplements, blocking agents for ELISA methods, and excipient use in research products.

Our ability to optimize and customize essential test kit reagents has supported the development and commercialization of IVD assays around the globe. From human serum and processed plasma to derivatives such as human serum albumin (HSA), human gamma globulin (HGG), and bovine serum albumin (BSA), we offer a diverse range of products to meet your assay development needs.

Custom Processing Services
To support the scale-up and commercialization of your diagnostic assays, SeraCare offers custom processing services. We partner with our customers to develop client-specific product specifications to ensure you receive the materials that you need to effectively manufacture and commercialize your products.

Pre-screening
Processing – including filtration, heat and chemical treatments, and preservatives
Packaging

Flexible Portfolio Supports Evolving Test Methods
As a company proven to evolve with the needs of the diagnostic testing industry, we continue to support our clients with key components and raw materials to develop new test methods, including clinical genomics applications and advanced diagnostic testing applications such as next-generation sequencing. Partner with us as a trusted and experienced manufacturer to help you identify the best matrices for your diagnostic assays and accelerate your product development cycle.

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About Us

Company details
Company History

Founded in 1984, SeraCare has been a trusted partner and worldwide supplier to the diagnostic testing industry for over 30 years, advancing the development of clinical genomics, molecular, and serological diagnostics with innovative technology, quality controls, reagents, and biological materials.

As an ISO 13485-certified manufacturer with advanced technology including a complete QC solution and robust customization capabilities, SeraCare is a leader in reference standards to enable the promise of precision medicine and ensure correct results for NGS-based test providers, IVD developers and manufacturers, and clinical laboratories.

Our roots
Our early history in the 1980s shows our devotion to supporting diagnostics professionals when SeraCare developed the industry’s first seroconversion panels. SeraCare’s focus on serology continued into the 1990s, where we established our leadership in plasmapheresis and increased our focus on IVD raw materials.

Through strategic acquisitions and consolidations, we expanded our R&D capabilities, crucial for evolving with the demands of the molecular diagnostics industry during the early 2000s. Our expertise allowed us to recognize the increasing clinical applications of next-generation sequencing (NGS) and companion diagnostics.

Continuing advancements
In 2012, Linden Capital Partners acquired SeraCare and introduced our CEO, Charlie Mamrak, and a trusted leadership team who continues to expand SeraCare’s specialties for the overall goal of improving the quality of life through a global understanding of disease. The continued development of extreme quality, improved efficiency, and focus on meeting the demands of the evolving IVD industry has brought SeraCare to its trusted state today, serving more than 90% of the world’s top IVD manufacturers with an increasing client base every day.

2013 brought a strategic addition to SeraCare’s product portfolio with its acquisition of KPL, a trusted and experienced provider of primary and secondary antibodies for over 30 years, as well as reagents and reference materials needed for quality control applications. SeraCare also introduced its HIV-1 worldwide isolates in the AccuType portfolio, and launched our AccuPlex recombinant viral technology, enabling the development of custom recombinant controls and reference materials.

Supporting clinical genomics diagnostics
In 2015, we expanded our R&D facility in Gaithersburg, MD and launched a new clinical genomics business unit focused on the development of technologies and products to enable the safe and effective expansion of precision medicine-driven diagnostics. Understanding that our customers were transitioning to more data-intensive diagnostics methods and embracing new technologies, this business unit was formed to develop innovative solutions to support the accurate and precise use of advanced diagnostic platforms such as NGS and digital PCR.

Novel products for oncology, reproductive health, infectious disease, and inherited disease continually emerge from our pipeline in support of our clients’ development and validation efforts for clinical genomics diagnostics. During this time, our Seraseq technology was introduced to develop high-quality NGS reference materials. Additional and ongoing developments include reference materials for the molecular analysis of hematological malignancies, solid tumors, and liquid biopsy. 2017 saw the launch of our powerful, yet easy-to-use iQ™ NGS QC Management software that makes it simple for clinical labs to ensure optimal NGS assay performance and maintain compliance.

A pillar of support for our clients
Today, with more than 150 employees, SeraCare continues to operate out of our corporate headquarters in Milford, MA. With three facilities in Milford and our R&D facility in Gaithersburg, MD, our company is dedicated to ongoing commercial development, manufacturing, and distribution of quality control products for the industry. With an extensive global network and over 30 years of experience, we will continue to serve the needs of our clients – IVD manufacturers, clinical laboratories, and life science researchers – as technology and client needs evolve.

Company Culture

SeraCare employees enjoy a work environment that reflects our goal to be best-in-class. We strive for the highest standards of conduct in our relationships with each other, our customers, and our suppliers. Our performance management process engages people at all levels, and our professional development program emphasizes and supports continuing education and on-the-job training. The list below highlights some of our programs.

Diversity policy
We are committed to equal employment opportunity without regard to gender, race, religion, national origin, age, disability, citizenship, veteran or uniform service status, or any other status that is protected by applicable federal, state, and local laws.

Communication and education
SeraCare is committed to open and effective communication throughout the company. From quarterly town hall meetings to daily stand-up sessions, all employees are actively informed of day-to-day business operations.

Quarterly Town Hall – company-wide meeting where the CEO and senior leadership team communicate important updates, celebrate accomplishments, and present employee recognition awards
Lunch and Learns – presentations by employees and industry experts on relevant topics with complimentary lunch provided
Group Stand-Up Sessions – department meetings throughout the week to share updates within teams and across functions

Awards and recognition

Living Our Values Awards – given quarterly to individual employees and teams nominated by their peers for demonstrating one of SeraCare’s core values – curiosity, adaptability, relationships, and commitment
Spot bonus awards – peer-to-peer instant recognition for demonstrated performance above and beyond normal job duties
Service awards recognition – SeraCare takes pride in the longevity of our employees with service awards and recognition for employees, and we proudly have several employees celebrating more than 25 years!

Spirit committee events
The SeraCare Spirit Committee promotes team building and fun across the organization by planning functions, community support efforts, themed days, and more. Some of the events organized by our Spirit Committee include:

Red Sox home opener party
Earth Day recognition
Summer outings and cookouts
Summer ice cream truck visits
ALS Ice Bucket Challenge participation
Halloween costume contests
Saint Patrick’s Day and Valentine’s Day treats
Winter holiday party & ugly sweater contest
Big Brother Big Sister collections

Nature picture contest

Safety committee
SeraCare understands that a healthy and safe work environment is important to our employees and vital to the success of our company. Safeguarding the wellbeing of employees and visitors is a shared commitment of the entire SeraCare community.

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