Archive for 2023

Alpha Cognition, a biopharmaceutical company developing novel therapeutics for debilitating neurodegenerative disorders, is pleased to announce that the U.S. Food and Drug Administration (FDA) has completed its filing review and has accepted the company’s New Drug Application (NDA) for ALPHA-1062, a proprietary, patented, delayed release oral tablet formulation in development for the treatment of mild-to-moderate Alzheimer’s Disease. The NDA has been granted a Prescription Drug User Fee Act (PDUFA) goal date of July 27th, 2024.

Alpha Cognition is a publicly-traded spinout of PEI company Neurodyn.

The NDA submission is based on results from four studies the Company conducted demonstrating bioequivalence for ALPHA-1062 to galantamine and galantamine ER.  Adverse events documented across all studies for ALPHA-1062 were less than 2% and no insomnia was observed.

“The FDA’s acceptance of our NDA for ALPHA-1062 brings us another significant step closer to delivering a much-needed treatment to patients suffering from Alzheimer’s Disease,” said Michael McFadden, Chief Executive Officer of Alpha Cognition. “We look forward to continuing our collaboration with the FDA throughout the review process.”

Two PEI Bioscience Cluster companies Island Abbey Nutritionals and Somru Bioscience have both been selected as finalists for the Greater Charlottetown Area Chamber of Commerce 2024 President’s Excellence Award in the category of Innovation Excellence. The Innovation Excellence Award, sponsored by BIOVECTRA, recognizes a business that has demonstrated outstanding performance and achievement through innovative and creative approaches, resulting in new or improved programs, products, services or initiatives. The finalists are: Island Abbey Nutritionals, Somru BioScience, and Check Point Software Technologies.

On Wednesday, January 24, 2024, the GCACC will host the 2024 President’s Excellence Awards at the Delta Hotel in Charlottetown. Sponsored by Atlantic Lottery, the Chamber’s biggest night of the year will recognize and celebrate twenty-six finalists across nine award categories.

“It’s an honour for us to host our business community for this prestigious awards night where we celebrate excellence, innovation, service, and workplace excellence for our community,” said Kim Griffin, GCACC President. “Our members are truly partners in prosperity for our community today and for the future.”

About Island Abbey Nutritionals
Island Abbey Nutritionals™ is an innovative food science company based out of Prince Edward Island, Canada. With an impressive library of proven formulations, our state-of-the-art facilities specialize in manufacturing technology for gummy and lozenge production. As industry leaders, we provide full contract manufacturing, bottling, and packaging capabilities for a variety of supplementary and natural health-focused dietary needs.

About Somru Bioscience
Somru Bioscience is an emerging biotechnology company dedicated to developing breakthrough antibody technology for research, diagnostic and therapeutic applications. The company utilizes a unique and proprietary Somru™ technology which produces antibodies with superior binding affinity and bioactivity in a wide variety of biological assays in a short period of time.

Read full article on Page 28: https://www.biotech.ca/news/insights-magazine/

Montreal, QC – The Canadian Alliance for Skills and Training in Life Sciences (CASTL) unveiled its new biomanufacturing training facility in Montreal, Quebec yesterday afternoon. Located at the Angus Technopole in east Montreal, the new facility responds to the demand for highly skilled personnel in Quebec’s growing biomanufacturing sector by offering a wide range of technical bioprocessing training.

“This is a major milestone in CASTL’s mission to enable the growth of the biomanufacturing and life sciences sector. Thanks to the incredible support of the Quebec Government, our national lead partners adMare BioInnovations, and various other partners, CASTL will deliver industry-informed technical training, preparing the current and future workforce for the growth and innovation of Quebec’s fast-growing biomanufacturing sector,” said CASTL’s Executive Director, Penny Walsh-McGuire.

The new CASTL biomanufacturing training facility contains state-of-the-art pilot-scale bioprocessing equipment that will allow employees to gain practical skills that are immediately transferable to the operations and workflows used in biomanufacturing. The facility is equipped with laboratories and classroom spaces built to deliver biomanufacturing training at the highest level of quality. The facility mimics biologics production processes such as those used to manufacture monoclonal antibodies, vaccines, viral vectors and other biopharmaceutical products of cGMPs. This includes upstream, downstream and supporting equipment, including a solution and preparation area, a cell culture laboratory, bench-top and pilot-scale single-use bioreactors, chromatography and filtration systems and other equipment.

The establishment of this training facility was made possible through an investment of $2.5 million dollars from the Quebec government.

“Today’s investment will help ensure Quebec’s growth and autonomy in drug manufacturing. The creation of the CASTL biomanufacturing training centre in Montreal consolidates Quebec’s position as a leader in the strategic biomanufacturing sector,” added Pierre Fitzgibbon, Minister of the Economy, Innovation and Energy, Minister responsible for Regional Economic Development and Minister responsible for the Metropolis and the Montreal Region.

According to BioTalent Canada’s 2021 labour market research, Quebec’s bioeconomy will require more than 15,500 additional employees by 2029, with some of the highest demand being in biomanufacturing. CASTL will help fill the demand for skilled individuals.

“As CASTL’s National Lead Partner, adMare is delighted to welcome CASTL to the Quebec life sciences ecosystem,” says Kristy Lonergan, Senior Director of the adMare Academy. “CASTL’s new biomanufacturing training facility is a critical step forward in growing the sector by addressing the talent gap through providing Canadian life sciences talent with the skills needed to develop their careers and simultaneously attracting new talent to Quebec.”

With this new facility, CASTL will deliver on-site customized hands-on and theoretical training for entry-level employees through to senior management and post-secondary students. Courses are set to start in January 2024.

“CASTL’s training facility is a critical asset, nurturing skills for the dynamic biomanufacturing sector and fueling innovation. Cutting-edge science requires cutting-edge talent. We at Moderna recognize the value of this initiative, which promises to foster a robust talent pool, ready to contribute not only to our advanced mRNA manufacturing facility, but also to the broader biotechnology industry,” stated Roger Ngassam, Manufacturing Site Head Canada, Moderna

CASTL is the exclusive provider of the National Institute for Bioprocessing Research and Training (NIBRT) licensed training programs in Canada. Based in Ireland, NIBRT develops and delivers state-of-the-art training and education programs for the world’s leading biopharmaceutical manufacturing companies.

“NIBRT is proud to partner with CASTL in its mission to advance biomanufacturing training in Canada. The unveiling of CASTL’s new biomanufacturing training facility in Montreal marks the next exciting step in this journey. NIBRT’s collaboration with CASTL is a testament to our shared dedication to equipping individuals with the skills and knowledge needed to thrive in the field of biopharmaceutical manufacturing. The provision of biopharma workforce skills remains a huge global challenge, and we at NIBRT are delighted to share our world-leading training capability to the support the development of the Canadian life sciences sector through this cutting-edge facility, which will play a pivotal role in shaping a highly skilled workforce for the future,” said NIBRT’s CEO Darrin Morrissey.

For more information on CASTL training programs visit www.castlcanada.ca or contact info@castlcanada.ca

The innovative program will train 400 future biomanufacturing workers with in-demand skills

Charlottetown, PE – Today, the Canadian Alliance for Skills and Training in Life Sciences (CASTL) announces the launch of its national biomanufacturing skills and training program – CASTL Elevate. CASTL Elevate is powered by Upskill Canada, and is part of the first wave of partnership programs that are taking an industry-informed approach to supporting workers in Canada’s fast-growing biomanufacturing sector. Support from Upskill Canada will allow CASTL to train up to 400 new biomanufacturing workers with the in-demand technical and essential skills training for careers in this innovative sector.

As part of the 10-week program, CASTL will prepare participants for biomanufacturing technician roles through a series of self-directed and instructor-led learning, along with hands-on experience at one of CASTL’s state-of-the-art biomanufacturing training facilities. The comprehensive training program is designed to present technical skills and knowledge in good manufacturing practices (GMP), good documentation practices (GDP), following standard operating procedures (SOPs), gowning for work in a biomanufacturing environment, cleaning in a biomanufacturing environment, using basic and foundational equipment, and understanding various roles and processes in a biomanufacturing environment. In addition to technical training, participants will benefit from professional development, job search coaching,  and networking opportunities with industry experts.

The program is designed to assist younger workers, new Canadians, diverse populations, and others in recognizing transferable skills, acquiring new knowledge and launching new careers in Canada’s biomanufacturing sector.

Supported by funding from Innovation, Science and Economic Development Canada’s (ISED) Upskilling for Industry Initiative, more than 15,000 Canadian workers will benefit from an innovative approach to skills training. Central to the Upskill Canada initiative is the role of community training providers, who work closely with local and national employers to identify precise suites of skills being sought by industry. Equipping workers with these skills will create new career pathways for Canadians and better position Canadian companies to compete both domestically and internationally.

Quick Facts

• CASTL is a national skills and training organization formed to address the talent needs of Canada’s life sciences sector.
• Specializing in biomanufacturing, CASTL delivers on the economic and sectoral demand for individuals who have the technical skills to enter, thrive and meet the needs of the fast-growing Canadian biomanufacturing industry.
• With headquarters in Prince Edward Island, CASTL operates GMP-like biomanufacturing training facilities in Charlottetown, PE and Montreal, QC. In partnership with the BC Institute of Technology, CASTL will open a third facility in Richmond, BC in Summer 2024.
• CASTL is the exclusive Canadian provider of the globally recognized National Institute for Bioprocessing Research and Training (NIBRT) licensed training programs. Based in Ireland, NIBRT develops and delivers state-of-the-art training and education programs for the world’s leading biopharmaceutical manufacturing companies.
• CASTL’s Elevate program will be delivered between December 2023-March 2025. Through this program, CASTL will training up to 400 new workers with the in-demand technical and essential skills training for careers in the biomanufacturing sector.
• The 10-week CASTL Elevate program will prepare participants for biomanufacturing technician roles through a series of self-directred and instructor-led learning along with hands-on experience at one of CASTL’s state-of-the-art biomanufacturing training facilities. English and French programs will be available to participants.
• Individuals interested in applying for the CASTL Elevate program can learn more and register at www.castlcanada.ca/en/elevate-program
• According to BioTalent Canada’s 2021 national labour market information study, Canada’s bioeconomy will require more than 65,000 additional workers by 2029, with some of the highest demand being in biomanufacturing.

Quotes

“We’re so proud to formally launch Upskill Canada with our inaugural class of workers and training service providers. This is a big first step – but it’s only the beginning. We’re looking forward to working with our supporters in government and industry to upskill many more Canadians, so they can transition into high-demand roles in the modern workforce – and help fast-growing companies achieve their full potential.”

– Rhonda Barnet, CEO of Palette Skills, which was chosen by ISED to run the Upskill Canada initiative

“CASTL is thrilled to present this new training program that will bring industry-informed skills and training to develop a much-needed talent pool for Canada’s fast-growing biomanufacturing sector. Thank you to Upskill Canada Canada and ISED for investing in this initiative and enabling us to support and develop the future workforce of Canada’s biomanufacturing industry.”

– Penny Walsh-McGuire, Executive Director, Canadian Alliance for Skills and Training in Life Sciences, a fund recipient and partner program of Upskill Canada.

Join us November 16 for a BioNetworking Session featuring the National Research Council Canada / Conseil national de recherches Canada. This event will feature informative presentations followed by lunch and networking, and the option to book 1:1 meetings with the NRC in the afternoon. You won’t want to miss it!

Thursday, November 16
⏰ 10 a.m. – 12:30 p.m.
Holman Grand, Charlottetown
✉ RSVP: https://lnkd.in/ei23yGcU

Schedule:

1 0 – 10:15 a.m. – Coffee and Networking

1 0:15 – 12 p.m. – Presentations and Q&A

1 2 – 12:30 p.m. – Lunch and Networking

1 :30 – 5 p.m. – Office Hours (Book a 1:1 Meeting with the NRC)

With presentations from:

Vice-President’s Office, Life Sciences

• Dr. Lakshmi Krishnan, Vice President of Life Sciences, National Research Council

Human Health Therapeutics Research Centre

• Dr. Sue Twine, Director General, Human Health Therapeutics Research Centre

Aquatic and Crop Resource Development Research Centre

• Denise LeBlanc, Director General, Aquatic and Crop Resource Development
• Dr. Jim Johnston, Director, Research and Development
• Dr. Stephen O’Leary, Research Officer and Team Lead, Algal Genomics & Synthetic Biology
• Dr. Anja Vogt, Research Officer and Team Lead, Analytical and Down Stream Processing

Medical Devices Research Centre

• Dr. Amaya Arcelus, Director General
• Dr. Priyum Koonjul, Director, Business Development

Human Health Therapeutics Research Centre / Business Team

• Dr. Paul Payette, Director, Business Development

An established manufacturer of gummies and honey lozenges in the health and wellness space, Island Abbey has been contract manufacturing for some of the industry’s leading brands for over 13 years. In the Summer of 2023, the company brought their newest manufacturing capabilities online with considerably increased capacity and new technology including a heavy suspension skid, enabling market-leading loads of active ingredients within a gummy, and increased capacity for their unique honey gummies.

To continue the forward momentum, the company has decided to clearly indicate its specialization as a manufacturer of gummy vitamin, mineral and supplement products by changing its name from Island Abbey Foods® to Island Abbey Nutritionals™.

“This is an exciting time for Island Abbey Nutritionals. Our change of name cements our strategic focus on the health supplements industry and ushers in a new era of gummy manufacturing for the company,” said CEO Dean Williams . “We have invested considerably in order to increase our production capabilities and to broaden the opportunity for brands to benefit from our new capabilities. Our new gummy line has a heavy suspension skid that enables us to manufacture great tasting gummies containing higher volumes of active ingredients that are traditionally difficult to manufacture in gummy form, e.g., calcium and magnesium gummies.”

Island Abbey Nutritionals’ new manufacturing capabilities were made possible by the installation of top-of-the-line gummy production equipment commissioned from Tanis. The Island Abbey Nutritionals team was closely supported by the Tanis team in all elements of the new line, from R&D to design, installation, and production. Victor Tanis , spokesperson from Tanis said “Island Abbey Nutritionals has recently installed an outstanding confectionery production line in their new facility. We have found their team extremely professional, knowledgeable, and collaborative to work with. This has been a project undertaken over several years, so we had the additional strains that the Covid-19 pandemic contributed to the project, but the team at Island Abbey Nutritionals has been proactive and positive throughout and we are very pleased to see the line up and running so well.”

The company, based on Prince Edward Island, Canada, has undertaken a capex expansion to meet the demand for new, innovative and delicious gummies in the health and wellness market. They have tripled their production space in recent years, and now have a state-of-the-art facility stretching over 70,000 square feet. The facility is certified GMP by NSF and is certified SQF under the GFSI scheme.

As a major employer on the island, Island Abbey Nutritionals worked closely with the Prince Edward Island BioAlliance, a private sector-led not-for-profit organization dedicated to building the bioscience industry on Prince Edward Island.

Rory Francis, CEO of the PEI BioAlliance said “Island Abbey Nutritionals is a great success story of the growing bioscience sector in PEI. They have expanded their markets to dozens of international countries and are continually innovating new products, and we look forward to working together and supporting them as a key organization in our PEI bioscience cluster.”

Williams said “Our increased production capacity and capabilities is not our only news, our Innovation team here at Island Abbey Nutritionals is working on some exciting new ingredients and benefit-driven gummies for our clients. From adaptogens to botanicals, energy to sleep, workout prep to immunity boosts, we are confident that our range of gummies, our high -volume high-efficiency manufacturing facility and our professional and experienced team here at Island Abbey Nutritionals will prove to be innovative disruptors in the gummy vitamin industry.”

A team from Island Abbey Nutritionals will be at Supply Side West 2023. Anyone wishing to learn more about Island Abbey Nutritionals’ capabilities can get in touch via the website to arrange a meeting at SSW or virtually.

For more information on Island Abbey Nutritionals, please visit the company website www.islandabbey.com.