Weekly Roundup: Lonza to acquire sterile fill and finish facility from Novartis, NZMP receives Good Energy Award

05 Jul 2019 --- In nutrition news this week, Lonza entered into a binding contractual commitment to acquire a sterile drug product fill and finish facility from Novartis, while Fonterra's NZMP was granted the Good Energy Award for its positive impact on the communities it affects. Alltech appointed a new Chief Scientific Officer to advance innovative research to improve the health and nutrition of animals, plants and people. Moreover, the American Herbal Products Association (AHPA) will hold a Hemp-CBD Supplement Congress to provide critical information for companies navigating the rapidly evolving legal, regulatory and financial landscapes.

In brief: Acquisitions and partnerships
Lonza has entered into a binding contractual commitment for the purchase of a sterile drug product fill and finish facility from Novartis. The closing is expected to take place within the coming months. The new facility in Stein, Switzerland, will enable Lonza Pharma & Biotech to build on existing parenteral drug product development and testing capabilities and offer an end-to-end service to its customers for clinical supply and launch. It will be the first sterile drug product fill and finish facility in Lonza’s network. The multi-product facility currently serves as the Novartis Center of Excellence for sterile clinical drug product manufacture. Following the closing, Lonza will produce drug products at the facility for Novartis, as well as providing capacity for additional customers. Operational since 2009, the facility includes classified cleanroom areas for cGMP manufacture as well as office, lab space, utilities and storage. The facility will continue to perform sterile manufacturing including liquid and lyophilized dosage forms for up to 200 liters bulk volume for clinical supply and commercial launch. Lonza will continue to employ the highly experienced team at the facility. 

Left to right: Dr. Ronan Power, Dr. Richard Murphy, Dr. Karl Dawson and Dr. Mark Lyons of Alltech.Provider of advanced software solutions for life science R&D Genedata has expanded its partnership with AB Enzymes, an enzyme manufacturer and member of Associated British Foods. As part of the expanded partnership, AB Enzymes has licensed Genedata Selector as its central bioinformatics platform for managing the genomic and phenotypic information of all production-relevant organisms. In addition to the software license, Genedata also provides data science as well as managed IT services. This full-service solution provides the required scalability as well as the flexibility for AB Enzymes to address the rapidly evolving needs of digitalization including workflow support, data integration, and process harmonization. A company spokesperson explains that standardization, automated processes and digitalization reduces R&D costs and makes the work in the R&D departments much more efficient as resources can be spent on other innovative projects e.g. microbiome projects, pre-and probiotics research. Also, in addition to the benefits like data harmonization and data quality, Genedata Selector has an integrated communications and collaborations platform within the software of the secure data management system. The outcome is a significant higher quality of R&D data, easier decision cycles based on harmonized data, easy access and interdisciplinary collaboration of the project team and as well as its documentation.

In brief: Awards and recognition
Fonterra’s NZMP was granted the Good Energy Award through its efforts in making a positive impact on its communities, during the Premier Nutrition awards 2018, held June 2019. Each Year Premier Nutrition awards three “Partners of the Year” the Builder, the Bell Ringer and the Good Energy awards. Premier Nutrition selected NZMP because the company believes that by giving back and improving how it operates, it can make a difference through the following areas:

• Nutrition: Fonterra Milk for Schools helps more than 140,000 schoolchildren get access to milk every day. This is the program’s fifth year, and it has delivered over 100M single serve milks to local children.
• Environment: Established in association with the New Zealand Department of Conservation in 2013, the Living Water program is dedicated to supporting a healthy freshwater ecosystem. 
• Community: The Fonterra Grass Roots Fund supports local initiatives that help strengthen the communities, care for the environment and promote healthy lifestyles. In 2018, an estimated US$1 million from the fund was distributed to 696 community initiatives. 

In brief: Appointments and retirements
Alltech has appointed a new Chief Scientific Officer to advance innovative research for the improvement of the health and nutrition of animals, plants and people. Dr. Ronan Power has assumed the role following the retirement of Dr. Karl Dawson this past June. Dr. Power joined the Alltech team in 1991 as the European Director of Research and has been closely involved in the development of Alltech’s product portfolio, including its organic selenium, Sel-Plex. He most recently served as the Vice President of Alltech Life Sciences, a division dedicated to researching gut and brain health in humans. As Chief Scientific Officer, Dr. Power will oversee more than 100 researchers worldwide, more than 20 research alliances spread over 12 countries and four bioscience centers, located in the US, China, the Netherlands and Ireland, where Dr. Richard Murphy leads the center’s activities. “Recent acquisitions have broadened our ability to apply solutions to any point along the food supply chain and provide transformative innovation to customers,” says Dr. Mark Lyons, President and CEO of Alltech. “With Dr. Power at the helm of our research team, Alltech will advance into the next frontier, supporting producers as they overcome today’s challenges and work toward a Planet of Plenty.”

In brief: Trade shows and symposiums
The AHPA is holding a two-day Hemp-CBD Supplement Congress to provide critical information for companies navigating the rapidly evolving legal, regulatory and financial landscapes to manufacture and market dietary supplement products with hemp or hemp-derived ingredients including cannabidiol (CBD). The US Department of Agriculture (USDA)’s Agricultural Marketing Service (AMS) senior marketing specialist William Richmond is scheduled to present an update on USDA efforts related to the recent decriminalization of hemp. The US Food and Drug Administration (USFDA) has also committed to present an update on the agency’s ongoing efforts to design and implement a regulatory framework to ensure informed access to safe, legal products. AHPA’s Hemp-CBD Congress features a full-day of presentations and discussions on Friday, August 16, and two, half-day workshops on Thursday, August 15, that will cover: 

• How to comply with FDA’s current good manufacturing practice (cGMP) requirements for dietary supplements – training by EAS Consulting Group.
• New dietary ingredient (NDI) notifications and generally recognized as safe (GRAS) for hemp as a food additive and dietary ingredient – presented by AIBMR Life Sciences.

Fonterra’s NZMP was granted the Good Energy Award.Following a successful workshop last year, Euromed is again partnering with the American Botanical Council (ABC), Extrasynthese, Botanicert and Hylobates to organize a symposium looking at how best to tackle adulteration of botanical ingredients. The event will be hosted within the prestigious 67th International Congress and Annual Meeting of the Society for Medicinal Plant and Natural Product Research (GA) on September 1, 2019, in Innsbruck, Austria. Entitled “Economic Adulteration of Botanical Ingredients,” the symposium touts a diversified program, with expert lectures on the different aspects of botanical adulteration and fraud, case studies exploring the health risks associated with counterfeit ingredients, the role of sourcing, as well as prevention tools for the industry and propositions for risk reduction and better quality control.

A symposium called “Speeding Towards–Omics, Chemical and Microbiological Food Analyses”, arranged by AOAC Europe and NMKL – NordVal International, was celebrated in Oslo, Norway, this past June. Scientists, technicians and companies discussed emerging technologies and techniques with an emphasis on recent advances and applications in food analyses, such as the different aspects of use, validation and application of “–omics” related to food (genomics, proteomics, transcriptomics, metabolomics), new rapid methods, hand-held instrumentation and digitalization of the analytical. AOAC Europe is a section of AOAC INTERNATIONAL, Association of Official Analytical Chemists, established in 1989 and includes AOAC members from the European countries and countries around the Mediterranean Sea. 

Edited by Kristiana Lalou