PRESS RELEASE: Empirical Bioscience Upgrades to ISO 13485:2016 Certification

Empirical Bioscience, a privately-held developer and manufacturer of enzymes, polymerases, and reagents for Molecular Biology applications, announced that it has achieved ISO 13485:2016 certification for Medical Device and Quality Management Systems, this is an upgrade from their ISO 13485:2003 certificate. This certification more closely aligns with FDA regulatory guidelines and is an international standard that outlines the requirements for a quality management system specific to the medical device industry.

ISO 13485:2016 is an internationally recognized quality standard intended to provide a quality framework focused on the consistent design, development, servicing and sale of medical devices that are safe and effective for their intended purposes. To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer expectations and regulatory requirements.

“This certification is further evidence of our commitment to quality and ensures every Empirical Bioscience customer – from research institutions to an OEM customer who purchases custom reagents and complete test kits – receives products and services of the highest standards for product performance, quality, consistency, and reliability,” said Beth Lowe, Quality Systems Manager of Empirical Bioscience. “With a focus on maintaining a world-class quality management system and as one of the few privately-owned companies in our market space, Empirical Bioscience is an organization that customers can confidently rely on to meet and exceed expectations,” said Des O’Farrell, President of Empirical Bioscience.

Empirical Bioscience produces high-grade PCR reagents and enzymes in its ISO 13485 certified facility in Grand Rapids, MI, USA and is a Registered Small Business Company.

LAB BULLETIN: New RNA Kits from Empirical Bioscience Offer Swift and Extensive Purification

Empirical Bioscience announce that they have introduced the EB Pure Total RNA Kit and the EB Pure DNase 1 Digestion Kit for the fast and reliable purification of RNA from cells or soft tissue.

The High-Bind configuration of the EB Pure Total RNA Kit specifically, but reversibly, binds RNA under optimized conditions allowing proteins and other contaminants to be removed. It also allows for the binding of RNA in high-salt and elution in a low-salt buffer, and each column can bind up to 100 µg of RNA, so no organic extractions or additional precipitations are necessary. This helps to guarantee high and stable recovery rates in 20 minutes or less. Extracted RNA is suitable for use in applications such as RTPCR, Northern blotting, poly A+ RNA (mRNA) purification, nuclease protection, and in vitro translation.

Continue reading at LabBulletin…

GENOMEWEB: Empirical Bioscience’s New EB Pure Plasmid Mini-Prep Kit Offers High-Quality DNA in 30 Minutes or Less

Empirical Bioscience has announced the launch of its new EB Pure Plasmid Mini-Prep Kit, which combines the firm’s High-Bind technology with alkaline-SDS lysis of bacterial cells. The kit’s High-Bind technology reversibly binds DNA or RNA under optimized conditions, removing proteins and other contaminants. The kit requires one to five milliliters of bacterial culture and delivers results in less than 30 minutes. It also isolates high-quality plasma or cosmid DNA for extraction up to 10 kilobases and yields up to 20 micrograms per preparation, the firm said.

Continue reading at Genomeweb…

GENOMEWEB: Empirical Bioscience EB Pure PCR Purification Kit

Empirical Bioscience has launched the EB Pure PCR Purification Kit to streamline DNA purification and recover high-quality DNA in 10 minutes. The kit uses silica-based technology, binding DNA in high-salt and eluting in a low-salt buffer, with no organic extractions or additional precipitation steps required. It includes binding buffer, activation buffer, elution buffer, washing buffer, spin columns, and collection tubes, and provides maximum recovery of DNA bands from 100bp to 10kb that are free of oligonucleotides, nucleotides, and polymerase, with yields exceeding 80 percent from DNA amounts of up to 20 µg.

Continue reading at GenomeWeb.com

GENOMEWEB: Empirical Bioscience Unveils New EB Pure PCR Purification Kit

Empirical Bioscience has launched the EB Pure PCR Purification Kit to streamline DNA purification and recover high-quality DNA in 10 minutes. The kit uses silica-based technology, binding DNA in high-salt and eluting it in a low-salt buffer without requiring organic extractions or additional precipitation steps. The kit includes binding buffer, activation buffer, elution buffer, washing buffer, spin columns, and collection tubes. In addition, the firm said it provides maximum recovery of DNA bands from 100bp to 10kb that are free of oligonucleotides, nucleotides, and polymerase, with yields exceeding 80 percent from DNA amounts of up to 20 µg.

Continue reading at Genomeweb…

BIOSPACE: EB Pure Agarose Gel Extraction Kit Offers Rapid Recovery of Fine Molecules

Empirical Bioscience announced today that they have introduced the EB Pure Agarose Gel Extraction Kit. The set is designed to quickly isolate small DNA fragments (70 bp to 20 kb) from Agarose Gel in just 15 minutes.

The system’s high-binding configuration specifically, but reversibly, binds DNA or RNA under optimized conditions allowing proteins and other contaminants to be removed. This helps to guarantee high and consistent recovery rates in excess of 85 percent, while simultaneously removing primer-dimers, primers, nucleotides, proteins, salt, agarose, ethidium bromide, and other impurities. The extracted DNA is suitable for use in most applications including ligations, PCR, sequencing, restriction digestion, or various labeling reactions.

“The enhanced filtration offered by our EB Pure Agarose Gel provides researchers with better resolution and allows them to recover more delicate molecules,” said Des O’Farrell, President of Empirical Bioscience.

Continue reading at Biospace…

PRESS RELEASE: EB Pure Agarose Gel Extraction Kit Offers Rapid Recovery of Fine Molecules

Empirical Bioscience announced today that they have introduced the EB Pure Agarose Gel Extraction Kit. The set is designed to quickly isolate small DNA fragments (70 bp to 20 kb) from Agarose Gel in just 15 minutes.

The system’s high-binding configuration specifically, but reversibly, binds DNA or RNA under optimized conditions allowing proteins and other contaminants to be removed. This helps to guarantee high and consistent recovery rates in excess of 85 percent, while simultaneously removing primer-dimers, primers, nucleotides, proteins, salt, agarose, ethidium bromide, and other impurities. The extracted DNA is suitable for use in most applications including ligations, PCR, sequencing, restriction digestion, or various labeling reactions.

“The enhanced filtration offered by our EB Pure Agarose Gel provides researchers with better resolution and allows them to recover more delicate molecules,” said Des O’Farrell, President of Empirical Bioscience.

Empirical Bioscience produces high-grade PCR reagents and enzymes in its ISO 13485 certified facility in Grand Rapids, MI, USA and is a Registered Small Business Company.

PRESS RELEASE: New RNA Kits from Empirical Bioscience Offer Swift and Extensive Purification

Empirical Bioscience announced today that they have introduced the EB Pure Total RNA Kit and the EB Pure DNase 1 Digestion Kit for the fast and reliable purification of RNA from cells or soft tissue.

The High-Bind configuration of the EB Pure Total RNA Kit specifically, but reversibly, binds RNA under optimized conditions allowing proteins and other contaminants to be removed. It also allows for the binding of RNA in high-salt and elution in a low-salt buffer, and each column can bind up to 100 µg of RNA, so no organic extractions or additional precipitations are necessary. This helps to guarantee high and stable recovery rates in 20 minutes or less. Extracted RNA is suitable for use in applications such as RTPCR, Northern blotting, poly A+ RNA (mRNA) purification, nuclease protection, and in vitro translation.

While DNase 1 digestion is typically not required for RNA purified with High-Bind RNA Mini Columns which remove most of the DNA without enzymatic digestion, some RNA applications may require further DNA removal. EB Pure DNase 1 Digestion Kit was designed to be used with EB Pure Total RNA Kit for those instances.

“Together, these two kits have allowed us to develop a system that efficiently, and more fully, removes DNA,” said Des O’Farrell, President of Empirical Bioscience. “This is critical, especially for those working on sensitive RNA applications,” he added.

Empirical Bioscience produces high-grade PCR reagents and enzymes in its ISO 13485 certified facility in Grand Rapids, MI, USA and is a Registered Small Business Company.

PRESS RELEASE: New EB Pure Tissue DNA Kit Offers Rapid and Reliable Extraction of Genomic DNA

Empirical Bioscience announced today that they have introduced the EB Pure Tissue DNA Kit, a convenient system that allows for the purification of genomic DNA from animal tissue in 20 minutes or less.

The all-inclusive kit features binding buffer, activation buffer, elution buffer, washing buffer, spin columns, protease solution, and collection tubes. The system’s high-binding configuration specifically, but reversibly, binds DNA or RNA under optimized conditions allowing proteins and other contaminants to be removed. This helps to guarantee high and consistent recovery rates, while simultaneously removing primer-dimers, primers, nucleotides, proteins, salt, agarose, ethidium bromide, and other impurities.

“Our New EB Pure Tissue DNA kit allows researchers to extract genomic DNA in a fraction of the time it would take with other methods,” said Des O’Farrell, President of Empirical Bioscience. “And with a lot less hassle,” he added.

What’s more, since the extraction kits allow for the binding of DNA in high-salt and elution in a low-salt buffer, no organic extractions or additional precipitations are necessary. The extracted DNA is suitable for use in most applications such as, PCR, Southern Blotting, and restriction enzyme digestion.

Empirical Bioscience produces high-grade PCR reagents and enzymes in its ISO 13485 certified facility in Grand Rapids, MI, USA and is a Registered Small Business Company.

PRESS RELEASE: Empirical Bioscience’s New EB Pure Plasmid Mini-Prep Kit Offers High-Quality DNA in 30 Minutes or Less

Empirical Bioscience announced the introduction of a new EB Pure Plasmid Mini-Prep Kit today. The kit combines the power of High-Bind technology with alkaline-SDS lysis of bacterial cells to deliver high-quality DNA in less than 30 minutes.

The kit’s High-Bind composition specifically, but reversibly, binds DNA or RNA under optimized conditions allowing proteins and other contaminants to be removed. Requiring only 1-5mL of bacterial culture, the kit also isolates high-quality plasma or cosmid DNA for extraction up to 10 kb in length and yields up to 20 µg per preparation.

In addition to using smaller volumes of cultures, the kit features an integrated pH indicator within the lysis buffer. This indicator changes color to bright yellow when the lysis buffer reaches the optimal pH level for DNA binding, 7.5. If the pH is greater than 7.5, the lysis buffer will appear orange or violet in color indicating that the pH level is inefficient for DNA absorption, allowing researchers to make adjustments to the mixture for more efficient plasmid isolation.

Besides the color changing lysis buffer, the kit includes neutralization buffer, Rnase A, activation buffer, washing buffer, elution buffer, spin columns, and collection tubes. These components create a versatile kit that lends itself well for use in most downstream applications, including automated fluorescent DNA sequencing and restriction enzyme digestion.

“This kit provides researchers with many advantages,” said Des O’Farrell, President of Empirical Bioscience. “In addition to requiring less bacterial culture, and offering rapid results, our kit produces more high-quality plasmid than competitor brands that use more culture.”

Empirical Bioscience produces high-grade PCR reagents and enzymes in its ISO 13485 certified facility in Grand Rapids, MI, USA and is a Registered Small Business Company.