PHARMA TECH

Fareva and ApiJect sign a licensing agreement to create a France-based 500M unit annual capacity for single-dose prefilled vaccine injections

ApiJect Systems Corp. | December 10, 2021

Fareva and ApiJect sign a licensing agreement to create a France-based 500M unit annual capacity for single-dose prefilled vaccine injections
Fareva and ApiJect Systems, Corp. announced a 10-year licensing agreement to install three Blow-Fill-Seal production lines that when operational will be able to fill-finish more than 500 million doses per year of vaccines and other large molecule injectable drugs using ApiJect's innovative prefilled injector technology. Fareva intends to invest more than €50M for these three manufacturing lines, with support from the Government of France, through the "France Relance" industry initiative and the Investments for the Future Program.

The three manufacturing lines and ApiJect's technology utilize the Blow-Fill-Seal aseptic packaging process. BFS has demonstrated its ability to package certain vaccines and large molecule formulations, and ApiJect is helping to expand BFS's capabilities to additional drug products, including temperature sensitive pharmaceuticals. When cleared by regulators, ApiJect will provide the necessary needle hub and other attachable components to convert finished BFS single-dose containers from these lines into easy-to-assemble, ready-to-use prefilled injectors.

COVID-19 has demonstrated the strategic importance of regional pharmaceutical manufacturing to ensure strong and reliable medical supply chains. By investing in these three BFS lines and installing ApiJect technology, Fareva is helping to increase Europe's high-speed, high-volume fill and finish capacity by potentially more than 500 million doses per year. And, the compact polyethylene-based supply chain of BFS helps establish and maintain dependable and resilient fill-finish capacity, even in the face of additional COVID-19 pandemic waves and their supply chain repercussions.

"This commitment by Fareva, with the support of the French Government, to expand fill-finish capacity is the right step at the right time. We are proud to partner with Fareva in bringing the next generation of injection technology to global health."

ApiJect CEO and Chair Jay Walker commented

Mr. Walker continued: "Our mission at ApiJect is to support and execute a strategy of expanded distributed fill-finish capacity in the U.S. and regionally around the world. This is desperately needed in the battle against COVID, particularly as we continue to face emerging variants. Distributed fill-finish capacity will also yield huge dividends when future pandemics and other possible bio-emergencies threaten our populations. Fareva, along with its support from the French Government, is showing itself to be a vital leader in confronting and defeating the COVID threat." 

The new lines will be situated in Fareva Excelvision, located in Annonay, France, which has more than 50 years of experience manufacturing BFS containers and exporting products around the world. The BFS machines will be purchased from Rommelag in Germany. Clean rooms for these new lines will be operated in a Biosafety Level 2 (BSL2) environment, allowing them to handle most vaccines. The objective is to start the first validation batches in June 2022. In addition, this capacity expands ApiJect licensing of its BFS manufacturing and device technology to the USA and Europe.

Olivier Dussopt. Minister Delegate for Public Accounts said: "I am very happy that Fareva, and their manufacturing site of Annonay in Ardeche, invests in such a development project, concerning 3 production lines for an amount of 50 million euros. The government will support those investments with a program of 36,9 million euros. This is an excellent news for the local territory as it will create 150 jobs and this is also an excellent news for France and Europe that will benefit from this high technology for the manufacturing of pharmaceutical drugs and more precisely of vaccines. "

Agnès Pannier-Runacher, Minister Delegate for the Industry declared: "I welcome the project implemented by Fareva in collaboration with ApiJect, a world premiere that will enable the production up to 500 million of injectable pharmaceutical products from 2022. This ambitious 50 million euros project will strengthen our healthcare industry in France and shows that innovation is not only in the vaccines but also stands in the injection devices. It is also the reason why we have agreed to support it with the France Relance program."

ABOUT APIJECT SYSTEMS, CORP. 
ApiJect Systems, Corp. is a public-benefit medical technology company working to bring prefilled, single-dose injections to more people in every market. The ApiJect Platform enables pharmaceutical and biotech companies to design scalable prefilled injectors and efficiently fill-finish them with their injectable drug products. This can be done either on one of their own ApiJect-licensed Blow-Fill-Seal packaging lines or at one of our world-class manufacturing partners.

ABOUT FAREVA
Fareva, a family-owned company, whose strength lies in its financial independence, is one of the world's leading CDMOs in the pharmaceuticals, cosmetics, make-up, and industrial and homecare fields. Fareva operates in 12 countries with 42 factories and employs more than 13 000 employees with annual revenues reaching € 1.8 billion in 2020.

ABOUT "FRANCE RELANCE"
France Relance is a €100 billion investment plan designed to support economic recovery in France in the wake of the COVID-19 pandemic. The program supports businesses, new production models, transformation of infrastructure, and training investment.

Spotlight

RecunnectLtd takes the pleasure to invite professionals involved in pharmacovigilance, risk assessment and management, clinical research, data analysis and related fields for a two day conference on Pharmacovigilance to enable them to gain a vantage point in the contemporary pharma industry by ingraining themselves with updates on regulatory trends in inspections of signal detection, post authorisation safety studies, optimal use of social media in pharmacovigilance, data mining technology, outsourcing Pharmacovigilance and strategic pharmacovigilance pre and post product life cycle. For more information, please visit our website – www.recunnect.com. To get in touch with us, please email info@recunnect.com or call +44 (0) 2071129183. For registrations, Please use the discount voucher code to avail extra £50 off online registration. For group discounts and bookings, please email info@recunnect.com For full terms and conditions, please visit www.recunnect.com/terms-conditions

Related News

BUSINESS INSIGHTS

Azzur Group Announces Executive Leadership Changes

Azzur Group, LLC | January 13, 2022

To support rapid company growth and best meet the demands of the business, Azzur Group announces new executive leadership appointments. Originally founded in Philadelphia in 2010, Azzur is a market-leading provider of GxP services for the pharmaceutical, biotechnology, medical device, and healthcare industries with offices and on-demand cleanrooms locations throughout the United States. Today, the organization provides comprehensive GxP solutions through its on-demand cleanrooms, consulting and advisory services, microbiology labs, and aseptic and GxP training. Ryan Ott has been promoted to Chief Operating Officer of Azzur Group. A long-time partner at Azzur, Ryan most recently served as Chief Administrative Officer. During his tenure, he has been instrumental in the overall strategic development of Azzur Group, initially in the Greater Philadelphia Region, while taking on additional responsibility with ongoing national expansion. In his new role, he collaborates with corporate and service-line leaders throughout the organization to execute on Azzur Group's strategic business plan. This includes Shaleen Parekh, who has been appointed to Sr. Vice President of Professional Services, with continuing oversight for Azzur Consulting, Azzur Labs, and Azzur Training Center; and Molly McGlaughlin, who has been appointed Sr. Vice President of Facilities Services, with continuing oversight for Azzur Cleanrooms on Demand™ as its Chief Operating Officer. Appointed to the new role of Chief Innovation Officer is Ravi Samavedam. In this role, he will focus on bringing forward new business concepts and service areas for Azzur's continued expansion. Ravi's extensive life sciences industry experience and dynamic leadership of Azzur Cleanrooms on Demand™ from its creation in 2018 through its national expansion, ideally position him to proactively identify novel service offerings for the enterprise. Most recently, Ravi served as President and COO of Azzur Cleanrooms on Demand™. He has been a member of Azzur Group since 2014. Ilya Vasserman has been promoted to Chief Information Officer (CIO) of Azzur Group and is responsible for overseeing the management and scale-out of Azzur's corporate information technology infrastructure while forming and leading a new corporate-wide procurement group. Ilya will also continue to spearhead technology adoption and internal tool development, furthering our business insights capabilities. Ilya most recently served as Senior Director of Financial Services and has been a member of Azzur Group since 2016. After nearly two years with Azzur Group, David Frank has been promoted to Vice President of Client Development, furthering the growth and maturation of Azzur's business development and marketing capabilities. As part of his expanded responsibilities, David will work closely with the executive leadership team to develop client-centric strategies across the organization to meet customer needs. Since joining Azzur Group in 2020, David has served as the Senior Director, Sales and Marketing. "I'm incredibly thrilled to announce the changes to the Azzur Group executive leadership team. Not only have these individuals proven to be excellent strategic partners for our enterprise, but each embodies Azzur Group's core values in their daily leadership. I offer my sincerest congratulations to Ryan, Ravi, Shaleen, Molly, Ilya, and David, and wish them much success in their new roles." Michael Khavinson, Azzur's Chief Executive Officer About Azzur Group Azzur Group provides the life science community with full lifecycle solutions for all their GxP needs. From Azzur Cleanrooms on Demand™ facilities, to labs, training centers, and consulting and advisory offices across the nation, Azzur helps organizations start, scale, and sustain their enterprises. With four decades of service to the industry, we've become a trusted partner to leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain.

Read More

PHARMA TECH

Piramal Pharma Solutions Announces Sterile Fill/Finish Program Theratechnologies Inc

Piramal Pharma Solutions, Theratechnologies Inc. | January 25, 2021

Piramal Pharma Limited's Pharma Solutions business, a leading contract development and manufacturing organization (CDMO), today declared that it is giving Theratechnologies Inc. with GMP manufacturing of sterile fill/finish drug item to help their developmental item as it goes into a first-in-people clinical investigation. The clinical material is being created at the Piramal Pharma Solutions (PPS) manufacturing site in Lexington, Kentucky, which is perceived around the world for its skill in sterile fill/finish administrations. It will be utilized in a Phase I preliminary for TH1902, Theratechnologies' lead peptide-drug conjugate (PDC) (docetaxel conjugate). The Phase I preliminary plan incorporates a portion acceleration study to assess the security, pharmacokinetics, most extreme endured portion (MTD) and fundamental enemy of tumor movement of TH1902 managed once at regular intervals in patients with cutting edge strong tumors headstrong to accessible enemy of malignant growth treatments. According to Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions, "Our Lexington team went the extra mile to provide solutions to ensure timely formulation development and production of the material. It's yet another example of how we are focused on working with our customers to reduce the burden of disease on patients." About Piramal Pharma Solutions Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs and finished dosage forms. We also offer specialized services like development and manufacture of highly potent APIs and antibody drug conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve innovator and generic companies worldwide. About Piramal Pharma Limited Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, offers a portfolio of differentiated products and services through end-to-end manufacturing capabilities across 14 global facilities and a global distribution network in over 100 countries. PPL includes an integrated contract development and manufacturing (CDMO) business, Complex hospital generics business, and India Consumer Products business, selling over-the-counter products in India. In addition, it has a joint venture with Allergan, a leader in ophthalmology in the Indian formulations market. In October 2020, PPL received 20% strategic growth investment from the Carlyle Group. About Theratechnologies Theratechnologies is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs.

Read More

CSA Medical Announces First Procedure in the SPRAY-CB Pivotal Trial for the Treatment of Chronic Bronchitis

CSA Medical Inc | October 22, 2020

CSA Medical Inc., a developer of medical devices advancing the power of liquid nitrogen spray cryotherapy, today announced the first patient treated in the SPRAY-CB, U.S. pivotal trial utilizing the RejuvenAir® System for COPD with Chronic Bronchitis at Temple University. Gerard J. Criner, MD, FACP, FACCP, Chair and Professor of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University (LKSOM) and Director of the Temple Lung Center, and principal investigator completed the procedure on October 14th. "We are pleased to have performed the first procedure in this landmark pivotal trial, building on the European data in which patients achieved meaningful improvements in their cough and overall quality of life," said Dr. Criner. "RejuvenAir Metered Cryospray is a promising new interventional tool that has the potential to reduce emergency hospital visits due to chronic bronchitis symptoms. This definitive intervention may provide a long-term benefit to millions of adults suffering with Chronic Bronchitis."

Read More

Spotlight

RecunnectLtd takes the pleasure to invite professionals involved in pharmacovigilance, risk assessment and management, clinical research, data analysis and related fields for a two day conference on Pharmacovigilance to enable them to gain a vantage point in the contemporary pharma industry by ingraining themselves with updates on regulatory trends in inspections of signal detection, post authorisation safety studies, optimal use of social media in pharmacovigilance, data mining technology, outsourcing Pharmacovigilance and strategic pharmacovigilance pre and post product life cycle. For more information, please visit our website – www.recunnect.com. To get in touch with us, please email info@recunnect.com or call +44 (0) 2071129183. For registrations, Please use the discount voucher code to avail extra £50 off online registration. For group discounts and bookings, please email info@recunnect.com For full terms and conditions, please visit www.recunnect.com/terms-conditions