Boston BioProducts Receives ISO 13485:2016 Quality Certification
6.4.2023 16:03:00 EEST | Business Wire | Press release
Boston BioProducts, a longstanding manufacturer of fundamental reagents for the life sciences, today announced that its quality management system (QMS) has achieved ISO 13485:2016 certification from TÜV SÜD America for the medical device manufacturing and supply of buffers, solutions, media, and reagents serving research, diagnostics, and therapeutics applications. Achieving this certification signifies Boston BioProducts’ commitment to high-quality standards across the entire reagent manufacturing process.
ISO 13485:2016 is considered the industry standard for QMS systems designed for medical devices and related services. It sets a robust and reproducible framework for the design, development, and manufacturing of products that meets customer and regulatory requirements. The International Organization for Standardization (ISO) is a global, independent publisher of standards governing the safety, reliability, and quality of manufactured products. TÜV SÜD America is among the most respected and accomplished certification bodies in the market serving thousands of registrations worldwide.
“This major company milestone further supports Boston BioProducts’ path to becoming a premier partner for contract reagent development and manufacturing across research, diagnostics, and therapeutics”, said Neil Sharma, General Manager of Boston BioProducts. “Scientists, assay developers, and manufacturing engineers can rely on a single source for the customization, testing, and supply of their process-critical buffers, solutions, and media reagents whether starting from innovation to publication, RUO to IVD, or preclinical to GMP.”
With the ISO 13485:2016 certification, Boston BioProducts is better positioned to support a range of growing regulated applications such as in vitro diagnostics, clinical trial assays , and cell and gene therapy manufacturing. This elevated quality management system complements the company’s flexible custom reagent manufacturing and rapid product delivery.
About Boston BioProducts
For nearly 30 years, Boston BioProducts (BBP) has manufactured and supplied fundamental reagents (buffers, solutions, media, and more) to researchers, diagnostic and technology platforms, and drug developers worldwide. With its custom reagent manufacturing services, BBP becomes an extension of your lab with flexible parameters to design the ideal research and manufacturing tools. Its mission is to increase the reproducibility of product- and process-critical reagents that keep your science consistent and moving forward. For more information, please visit www.bostonbioproducts.com and follow us on LinkedIn.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230406005030/en/
Contact information
Boston BioProducts Marketing
marketing@bostonbioproducts.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Galderma Receives U.S. FDA Approval for Differin ® Epiduo ® Acne Gel Prescription-to-OTC Switch22.5.2026 19:25:00 EEST | Press release
Galderma (SIX: GALD), the pure-play dermatology category leader, today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved Differin® Epiduo® Acne Gel (Adapalene 0.1% and Benzoyl Peroxide 2.5% Acne Treatment) for over-the-counter (OTC) use in ages 12 years and older, marking a significant Prescription-to-OTC transition in acne care. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260522074280/en/ The U.S. FDA approves Differin® Epiduo® Acne Gel Prescription-to-OTC switch This milestone represents yet another example of Galderma’s unique Integrated Dermatology strategy, demonstrating how proven innovations from its Therapeutic Dermatology portfolio can further strengthen its Dermatological Skincare offerings. The Prescription‑to‑OTC transition highlights Galderma’s scale and expertise in successfully commercializing dermatology innovations across the full spectrum of acne care. With the appro
Avanzanite Bioscience’s Partner Agios Announces PYRUKYND® (mitapivat) Approval in the European Union for Adults with Thalassaemia22.5.2026 17:18:00 EEST | Press release
Avanzanite Bioscience B.V., a rapidly growing commercial-stage European specialty pharmaceutical company focused on rare diseases, today reported that its partner, Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company headquartered in Cambridge, Massachusetts focused on delivering innovative medicines for patients with rare diseases, announced that the European Commission has granted marketing authorisation for PYRUKYND® (mitapivat), an oral pyruvate kinase (PK) activator, in adults for the treatment of anaemia associated with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassaemia, with an orphan medicinal product designation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260522186975/en/ Adam Plich, CEO and Co-Founder of Avanzanite Bioscience. “Thalassaemia is a complex, chronic and multisystem disease characterised by anaemia, ineffective erythropoiesis and haemo
ICE Brent and ICE WTI Perpetual Futures to Launch on OKX22.5.2026 15:30:00 EEST | Press release
OKX, a blockchain technology and trading company serving more than 120 million customers globally,and Intercontinental Exchange (NYSE: ICE), one of the world's leading providers of financial market technology and data powering global capital markets including the New York Stock Exchange, today announced plans for OKX to launch perpetual futures based on ICE's Brent Crude and WTI Crude energy benchmarks. The products are expected to be available to trade on OKX’s platform in jurisdictions where OKX is licensed to offer perpetual futures products. The new OKX contracts represent a major step forward in expanding regulated access to global commodity markets through digital asset infrastructure. This first product collaboration between OKX and ICE comes after the companies established a strategic relationship in March 2026. ICE operates some of the world’s leading exchanges, clearing houses and market data services across energy, commodities, fixed income and equities markets. ICE’s future
Enhertu ® Recommended for Approval in the EU by CHMP for Patients with Previously Treated HER2 Positive Metastatic Solid Tumors22.5.2026 15:00:00 EEST | Press release
Enhertu® (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment and who have no satisfactory treatment options. Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from patients with HER2 positive (IHC 3+) tumors in three phase 2 trials including DESTINY-PanTumor02,DESTINY-Lung01 andDESTINY-CRC02 where Enhertu demonstrated clinically meaningful responses across a broad range of tumors. The recommendation will now be reviewed by the European Commission, which has the authority
Future Health Challenge Awards USD 300,000 to Early Detection and Population Health Sensing Tools on Sidelines of World Health Assembly22.5.2026 14:45:00 EEST | Press release
Three global teams developing early detection and real-time population health monitoring solutions have secured a total of USD 300,000 on the sidelines of the 79th World Health Assembly. The winning solutions address critical challenges in early detection, continuous population insight and more timely decision making, signalling a shift in health systems from late-stage treatment to earlier intervention. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260522587414/en/ Selected from 393 submissions across 68 countries, the winning teams were recognised through the inaugural ‘Future Health Challenge 2026: Building Anticipatory Health Systems through Population Sensing’, delivered by Future Health – A Global Initiative by Abu Dhabi in collaboration with MIT Solve. Health systems globally are facing rising costs and persistent delays in diagnosis, with many conditions still identified only after symptoms become severe. At the sam
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom