Greiner Bio-One and Haematologic Technologies Announce a Collaboration to Provide Complete Development and Manufacturing of Customized Blood Collection Tubes in Support of New IVDs, Clinical Diagnostics, and Large Volume Production
MONROE, N.C. and ESSEX JCT., Vt., Aug. 20, 2020 /PRNewswire/ — Greiner Bio-One and Haematologic Technologies (HTI) are pleased to announce a collaboration to provide end-to-end development and custom manufacturing of blood collection tubes for IVD and clinical diagnostic device developers. The collaboration will marry HTI’s unique capability of producing pilot scale and small-to-medium sized batches of customized blood collection tubes with Greiner Bio-One’s custom blood collection tube manufacturing services, which excels at GMP-level manufacturing of high-volume batches. Through this collaboration, Greiner Bio-One and HTI will offer IVD and clinical diagnostic device developers a vertically integrated solution spanning from early development to large scale production of their custom collection tubes.
Linking the chain: An End-to-end solution
IVD and clinical diagnostic manufacturers designing new reagents to stabilize blood or other samples in a collection tube will now have a one-stop-shop to design, develop, and manufacture all necessary batch sizes of collection tubes to meet their needs throughout the entire process. What once would require the engagement of various vendors to fulfill different aspects of the development and marketing process can now be performed with one group.
“We’ve helped numerous diagnostic companies develop and manufacture small batches of customized collection tubes for evaluation purposes over the years. However, when those customers needed to scale up to large-batch, GMP manufacturing, we could not accommodate them. Having sourced our empty tubes and caps from Greiner Bio-One for many years, we have an excellent relationship with them, and this collaboration is a natural progression to a stronger partnership. Along with Greiner Bio-One, we will now be able to offer diagnostic developers a complete manufacturing service from development through to marketing, which allows them to focus more on their product and less on the details of the process,” said Robert Myers, HTI’s Vice President of Business Development.
“Greiner Bio-One’s OEM services division focuses on large-volume, GMP manufacturing of blood and specimen collection tubes and other plastic consumables. Our expertise is rooted in providing customers with large-scale manufacturing of the products they need in the healthcare, biotech, and pharma sectors. Historically it has been challenging to assist diagnostic developers with small, pilot-scale batches for evaluation purposes easily. Our collaboration now allows us to connect those customers to HTI while remaining involved to consult on the process to ensure that the technology transfers to high volume production seamlessly at the appropriate time for launch into the commercial market,” said A.C. Marchionne, President of Sales and Marketing for Greiner Bio-One.
About Haematologic Technologies, LLC
Haematologic Technologies (HTI) is the leading provider of biological products and analytical services to support the research, development, and commercialization of IVDs, clinical diagnostics, and large molecule biotherapeutics. Building on its 30+ years of expertise in plasma proteins, hemostasis, and blood coagulation, HTI manufactures research reagents (plasma proteins and antibodies), custom formulated IVD/POC device reagents, and customized blood collection tubes for clinical trials and for the development of novel diagnostics.
HTI has deep expertise in protein biochemistry including the purification and characterization of plasma proteins and other large molecules, and performs highly advanced assay development and GMP testing in the areas of immunoassays, thrombin generation assays, assessment of hemostatic risk, anti-drug antibody testing (immunogenicity), host cell protein mitigation, stability and release testing, as well as a variety of other specialized assays for biotherapeutics supporting discovery through commercial release. The company’s biopharma services are performed in fully compliant, FDA-inspected GLP, GMP, and CLIA facilities.
About Greiner Bio-One
Greiner Bio-One North America, Inc. is a privately held plastic manufacturing company located in Monroe, NC whose three divisions manufacture a variety of products for the medical and research fields. The manufactured products include plasticware for the cultivation and analysis of cell and tissue cultures, microplates for high-throughput screening related to drug screening, products for blood and specimen collection, tests for the detection of bacteria and viruses, as well as, custom-made products. As an international manufacturer with global reach, Greiner Bio-One provides the manufacturing, distribution logistics and product application support to the world’s largest hospitals, pharmaceutical and biotechnology corporations.
For more information about Greiner Bio-One North America, Inc. please visit http://www.gbo.com.