Somru CRO

Recommendations on ELISpot assay validation by the GCC

Gene therapy, cell therapy and vaccine research have led to an increased need to perform cellular immunity testing in a regulated environment to ensure the safety and efficacy of these treatments. The most common method for the measurement of cellular immunity has been Enzyme-Linked Immunospot assays. However, there is a lack of regulatory guidance available discussing the recommendations for developing and validating these types of assays. Hence, the Global CRO Council has issued this white paper to provide a consensus on the different validation parameters required to support Enzyme-Linked Immunospot assays and a harmonized and consistent approach to Enzyme-Linked Immunospot validation among contract research organizations. Keywords: cell therapy cellular immunity ELISpot Enzyme-Linked Immunospot GCC gene therapy global CRO council  regulated bioanalysis vaccine validation Read the article Read Full Article Learn. Engage. Connect. Learn | Engage | Connect Read news, updates, and transforming technologies of drug development Recommendations on ELISpot assay Gene therapy, cell therapy and vaccine research have led to.. Read More … Bringing more affordable medicines News release Governments of Canada and Prince Edward Island contribute.. Read More … Solution Quality & Speed. Delivered Immunogenicity Learn More Biosimilar Development Learn.. Read More … Cell-based Assays Cell-based Assays Solutions Cell bank and cell culture Custom method.. Read More … Ready to get started? Consult with a Scientist today! Let’s Talk

Somru BioScience gets $4M to research, develop affordable medicines

‘This is really about strengthening the local ecosystem’ Source: CBC News   Federal Minister Navdeep Bains joined co-founder Mohammed Moin and Chris Palmer, provincial minister of economic development and tourism, to make the announcement. (Brittany Spencer/CBC) The Charlottetown-based bioscience company Somru BioScience will receive over $4 million in federal and provincial funding to support its latest research and development project. P.E.I. bioscience company signs joint venture worth $150 million Federal Minister of Innovation, Science and Economic Development Navdeep Bains made the announcement at Somru’s facility Wednesday.  Bains, who is also the minister responsible for the Atlantic Canada Opportunities Agency (ACOA), said the government understands entrepreneurs take a lot of risks and this funding model promotes government investment and supports local innovation. “This is really about strengthening the local ecosystem, the local bioscience sector that’s growing and thriving right here in P.E.I.,” Bains said. Ready to get started? Consult with a Scientist today! Let's Talk

Bringing more affordable medicines to market

News release Governments of Canada and Prince Edward Island contribute over $4 million to support latest Somru Bioscience research and development project July 11, 2018 – Charlottetown, PE – Atlantic Canada Opportunities Agency Innovation is not a buzzword. It is a way of life and a driving force in today’s economy. It is about making things better, whether that’s new technologies, ideas, or products and services. It’s about creating well-paying jobs across Canada and having the potential to improve the lives of men and women around the world. The Honourable Navdeep Bains, Minister of Innovation, Science and Economic Development and Minister responsible for the Atlantic Canada Opportunities Agency (ACOA), along with Sean Casey, MP for Charlottetown and Parliamentary Secretary to the Minister of Canadian Heritage, and the Honourable Chris Palmer, Prince Edward Island Minister of Economic Development and Tourism, today announced an investment of over  $4.4 million to support Somru BioScience as they develop new analytical tools that can lead to more affordable medicines. The Government of Canada is providing a provisionally repayable contribution of $3 million through ACOA’s Atlantic Innovation Fund, in addition to contributions totaling up to $257,752 from the National Research Council of Canada Industrial Research Assistance Program. The Government of PEI will also contribute $975,000 in repayable financing along with $172,000 in non-repayable support to enhance the company’s marketing efforts. Canada’s Innovation and Skills Plan aims to position the country as a global centre for innovation—one that creates jobs, drives growth across all industries and improves the lives of all Canadians. These investments also build on commitments made by the Government of Canada and the four Atlantic Provinces to drive economic growth in the region through the Atlantic Growth Strategy. This Strategy focuses on building a strong culture of innovation by supporting creative and entrepreneurial people, creating jobs, and investing in state-of-the-art technologies.   Quotes   “The Government of Canada continues to make targeted investments that will create new opportunities in Atlantic Canada. I am pleased to join local success story, Somru BioScience, to announce an investment that will enable this company to continue its ground-breaking research. It is support for companies like this one that will help create sustainable, long-term economic growth with more secure, well-paying jobs for Atlantic Canadians.” The Honourable Navdeep Bains, Minister of Innovation, Science and Economic Development and Minister responsible for the Atlantic Canada Opportunities Agency “Prince Edward Island has a progressive and fast-growing bioscience sector and Somru BioScience is a leading force in that community. Somru’s products have attracted interest and attention from around the work and their success – in research and development, economic growth and job creation, and exports – is PEI’s success. I am so proud this company chose to call PEI its home.” Sean Casey, Member of Parliament for Charlottetown “Prince Edward Island’s bioscience sector has grown exponentially over the last ten years and companies like Somru BioScience are leading the way. Somru’s expansion and move into a new facility will allow this company to hire more employees, research and produce innovative new products, and seek out new markets all while making an improved contribution to the overall provincial economy.” The Honourable Chris Palmer, Minister of Economic Development and Tourism  “The intelligent 3d fingerprint technology (Intelli.b™) currently under development by Somru will help our clients reduce significant cost in biosimilar drug development. We look forward to advancing Intelli.b thanks to support from ACOA, IPEI and IRAP.”   Mohammed Moin, Co-founder & Vice President Strategic Partnership & Business Development, Somru BioScience Inc.  “Opening the new research laboratory facility is a major milestone for Somru. This accomplishment allows us to accelerate our R&D activities while continuing to provide comprehensive and innovative bioanalytical solutions to our clients.” Clarinda Islam, Co-founder & Vice President Project Management and Regulatory Affairs, Somru BioScience Inc. Quick facts Somru BioScience is a family-owned biotechnology company founded in 2012 by Mohammed Moin, his wife Dihan Ahsan, and Rafiq Islam and his wife Clarinda Islam. The company is focused on developing breakthrough antibody technology for research, diagnostic and therapeutic applications. Somru BioScience has continually grown its product and service portfolio. In October 2017, it expanded its operations to a new 5,000 square foot laboratory facility in the BioCommons Research Park in Charlottetown, Prince Edward Island. The company currently has a client base of over 70 companies in 23 countries. Ready to get started? Consult with a Scientist today! Let's Talk

A comprehensive bioanalytical solution for Denosumab(Prolia®, Xgeva®)

Somru developed the following comprehensive list of  bioanalytical assays to support Denosumab biosimilar  development  Pharmacokinetic Assay (PK) assay  ADA assay  Binding ADA assay  Cell-based NAb assay(s)  Ligand Binding NAb Assay   Pharmacodynamic Assays  sCTX  TRAP-5b  P1NP PK Assays to support Denosumab   Somru has developed an assay to support the pharmacokinetic  measurement of Denosumab   This assay utilizes the target (RANKL) as the capture and anti Denosumab for detection  Sensitivity – 25 ng/mL ELISA  Range: 2000 – 25 ng/mL ADA Assay to support Denosumab 1. SPEAD method  SPEAD method involves extraction of ADA from solid  phase bound to biotin-Drug  The assay utilizes acid dissociation   Depending on lot of positive control, ELISA sensitivity is  less than 100 ng/ml using a polyclonal rabbit affinity  purified antibody  Drug tolerance – 20 µg/mL  2. Somru does not recommend the use of SPR method due to the sensitivity  requirements of regulatory authorities and matrix effect  Neutralizing Antibody Assay  Cell-based Nab Assay  Utilizes RAW 267.4 cell line – This is macrophage-like, Abelson leukemia virus  transformed cell line derived from BALB/c mice. The end point is measurement  of TRAP using an ELISA assay. The assay is highly variable. To overcome this,  we have developed a reporter-cell line based NAb assay.  Reporter-cell line-based NAB assay – utilizes modified cell line with reporter  gene utilizing RANK/RANKL interaction to verify neutralizing antibody  Ligand binding NAb assay – Somru has also developed a ligand binding  method for the detection of NAbs.    Sensitivity – 500 ng/mL  Pharmacodynamic Assay Somru has validated antibody pairs for the measurement of the following  biomarkers in ELISA or ECL format in a functionally relevant manner to  support Denosumab biosimilar development  sCTX   TRAP-5b   P1NP  Ready to get started? Consult with a Scientist today! Let's Talk