Plastibell : an expert in Medical Devices

plastibell

On February 7 and 8, Plastibell attended the Pharmapack show, a key event in the pharmaceutical packaging and drug delivery calendar.

Plastibell (headquarters in Izernore, France), is an expert when it comes to injection molding and assembly, producing a broad range of complex plastic products for different industries.
The company is internationally active with seven industrial sites in four countries.
The Healthcare Division accompanies its customers in the development of Medical and In Vitro Diagnostics Devices (MD/IVD), from the earliest design stage, right through production.

Stiplastics launches an adjustable spoon designed to dispense mini-tablets

STIPLA

Always at the forefront of innovation, the Isère SME is anticipating rapid growth of this new galenic device.

Stiplastics, specialised in creating, developing and producing plastic solutions for the pharmaceutical industries and the health and e-health sector, has developed a new spoon which makes dispensing mini-tablets easy.

Very simple to use, this first multi-dispensing device can be used to dispense from 1 to 24 mini-tablets. Simply select the desired dose by dipping the spoon into the jar containing the tablets and then withdraw it filled with the prescribed number of mini-tablets. Any patient contact with the medicine is avoided, thus offering total hygiene and safety.

This new galenic solution, the micro-tablet, meets the obligation of the pharmaceutical laboratories to develop paediatric forms as imposed by the European Regulation (No. 1901/2006) which entered into force in January 2007 and which stipulates that, when the pathology is not specific to adults, any new medicine must also be offered in a paediatric version for the five following classes:

– Preterm infants
– New-born infants from 0 to 27 days
– Very young children from 1 to 23 months
– Children from 2 to 11 years
– Adolescents from 12 to 16 or 18 years.

“The studies we carry out and feedback from our customers, patients and health professionals have encouraged us to develop this spoon because we are convinced that the micro-tablet form is one that is going to develop strongly in the near future. Since it is the smallest solid form that can be administered individually, it allows subdivisions of the dosage and therefore a very accurate dose to be administered with a high concentration of active ingredients and few excipients. This has several advantages such as ease of use, a reduction in swallowing problems and the ability to adapt the dose according to physiological parameters, thereby reducing the risk of over or under-dosing. This is of particular interest in the treatment of rare diseases or in paediatrics. It also provides a solution for adults experiencing swallowing problems such as the elderly. This first device is ready for production and it is fully in line with our philosophy of facilitating and making the everyday life of patients and health professionals more pleasant” Virginie Delay, Marketing Director & STICARE BU Manager, stated.

Sanner and Amiko advance true medication adherence

sanner

At Pharmapack Europe in Paris, Sanner and Amiko presented their cooperation for the development of smart add-on solutions for inhaled drug delivery systems. Sanner Ventures, parent company of Sanner GmbH and corporate venture capital office specializing in new technologies in the area of health and well-being, supports Amiko Digital Health Limited with a strategic investment. The funds will be used to expand Amiko’s flagship product, the Respiro platform, an innovative respiratory disease management tool.

 

 

Heading towards true medication adherence

On the operational side, Sanner GmbH, headquartered in Bensheim, Germany, will work closely with Amiko to incorporate the start-up’s patented sensor technology into custom add-on or integrated device solutions for pharmaceutical clients. “Sanner has profound experience in moisture protection solutions and custom-made primary plastic packaging, as well as in design for manufacturing and industrialization of drug delivery systems,” says Dirk Mähr, Managing Director of Sanner GmbH. “Together with Amiko’s digital Respiro Platform and unique sensor technology, we will transform our synergies into smart solutions for true medication adherence in respiratory care.”

Amiko, winner of the 1st prize at the IBM Watson AI XPRIZE annual Milestone Award 2017, is upgrading respiratory care with sensors and AI technologies. Amiko’s Respiro platform, which has recently received the CE mark for use with certain inhaler systems, enables real-time monitoring of medication use and patient health. The patented Respiro Sense sensors, which are attached to dry powder inhalers, not only track device usage. They also facilitate true medication adherence by ensuring the medication is administered in the right way following the right technique. “Our digital health tools assist healthcare professionals and empower patients to achieve better respiratory treatment results,” says Duilio Macchi, CEO and Co-Founder of Amiko. “Together with Sanner we will advance our mission to upgrade respiratory care, improve health outcomes and reduce the costs of care for pulmonary diseases via AI-powered mobile health solutions.”

Schott AG, ARaymondlife and Vanrx Pharmasystems announce product compatibility for primary packaging of sterile injectables

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SCHOTT AG and ARaymond Life are announcing that SCHOTT adaptiQ® vials and ARaymondlife RayDyLyo® plastic press-fit closures are confirmed as a Product Set for use with Vanrx Pharmasystems’ Aseptic Filling Work-cells. This Product Set is fully commercially available and ready-to-use (RTU), with closure integrity performance results available from the suppliers.

The compatibility testing was part of the Matrix Alliance, an industry initiative of leading packaging and component suppliers, which aims at providing pre-validated container/closure solutions to work on Vanrx’s Aseptic Filling Workcells.

Using this Product Set, pharmaceutical companies have the assurance that the combination will function as a high-performance primary packaging system for sterile injectables. Companies can move drug products to market faster, by establishing flexible manufacturing operations using pre-sterilized, nested ready-to-use vials and press-fit closures with integrated stoppers in combination with Vanrx’s robotic aseptic filling systems.

A specific advantage of RayDyLyo® plastic press-fit caps is that they stopper and seal containers in one step, replacing aluminum crimp caps and eliminating their particle risk.

In selecting a Product Set, pharmaceutical companies receive assurance that all elements of the set, vials and caps, have been proven for compatibility and machinability with Vanrx aseptic filling systems.

As of this date, Product Set combinations are available in ISO standard 6R, and 10R vials, and corresponding 20mm press-fit closures. Contacts to request samples and performance specifications are listed below. These products are certified to work with Vanrx’s Microcell Vial Filler and SA25 Aseptic Filling Workcell.

Speaking on behalf of the three companies, Vanrx’s vice president of marketing Greg Speakman said:

“All three of our companies have seen how pharmaceutical companies are shifting toward building flexible manufacturing operations. SCHOTT, ARaymondlife and Vanrx are helping bring new products to market faster, benefiting the patient and our customers’ ability to respond to uncertain market conditions.”

The testing leading to this product set was completed as part of the Matrix Alliance, a collaboration between leading pharmaceutical packaging companies, of which Vanrx, SCHOTT, and ARaymondlife are members. The Alliance was created because next-generation drugs require high-ly aligned manufacturing processes and packaging solutions.

Roche to acquire Flatiron Health to accelerate industry-wide development and delivery of breakthrough medicines for patients with cancer

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Roche and Flatiron Health had announced that the two partners have signed a definitive agreement under which Roche will acquire all shares of Flatiron Health, following on from an existing equity stake of 12.6%. The transaction is expected to close in the first half of 2018.

Flatiron Health, a privately held healthcare technology and services company headquartered in New York City, US, is a market leader in oncology-specific electronic health record (EHR) software, as well as the curation and development of real-world evidence for cancer research. With its large network of community oncology practices and academic medical centers across the US, Flatiron Health has created a technology platform designed to learn from the experience of every patient.

Daniel O’Day, CEO Roche Pharmaceuticals said, “This is an important step in our personalised healthcare strategy for Roche, as we believe that regulatory-grade real-world evidence is a key ingredient to accelerate the development of, and access to, new cancer treatments. As a leading technology company in oncology, Flatiron Health is best positioned to provide the technology and data analytics infrastructure needed not only for Roche, but for oncology research and development efforts across the entire industry. A key principle of this is to preserve Flatiron’s autonomy and their ability to continue providing their services to all existing and future partners.”

Flatiron Health has worked with industry leaders and regulators to develop new approaches for how real-world evidence may be used in regulatory decision making, including the design and validation of novel endpoints. By working closely with its network of community practices and academic medical centers, Flatiron has also developed a suite of software products that uniquely positions the company to advance the use of real-world evidence at the point of care.

Nat Turner, Flatiron Health Co-Founder and CEO said, “Roche has been a tremendous partner to us over the past two years and shares our vision for building a learning healthcare platform in oncology ultimately designed to improve the lives of cancer patients. This important milestone will allow us to increase our investments in our provider-facing technology and services platform, as well as our evidence-generation platform, which will remain available to the entire healthcare industry.”

Under the terms of the agreement, Roche will make a payment of USD 1.9 billion to Flatiron Health on a fully diluted basis, subject to certain adjustments. The closing of the transaction is subject to customary closing conditions. The parties expect that following the closing, Flatiron Health will continue its current business model, network of partnerships and overall objectives. The integrity of segregated patient protected health information will be preserved, as will dedicated sales and marketing, provider-facing and life science business activities.

Merck and three partners start ExploreBio, a € 20 million pre-seed investment initiative in Israel

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Merck has announced ExploreBio, a pre-seed-investment vehicle by four investment funds targeted at early-stage companies in the biotechnology landscape in Israel. For this purpose the strategic corporate venture capital arm of Merck has partnered with Arkin Holdings, Pontifax and WuXi AppTec to create the € 20 million pre-seed investment vehicle.

“Israel’s start-up spirit is unique and so inspiring. We are proud to be an active part of this great success story. Now we are taking a next important investment step as we believe in the innovative potential of ExploreBio,” said Stefan Oschmann, Chairman of the Executive Board and CEO of Merck KGaA, Darmstadt, Germany.

ExploreBio is an initiative comprising pre-seed investments and management services for proof-of-concept-experiments in biotechnology. Additionally, companies benefiting from the ExploreBio initiative will be given the opportunity to work at the BioIncubator facilities of Merck KGaA, Darmstadt, Germany, in Yavne, Israel. Interested parties should submit their investment proposal here.

The commitment involves a total volume of € 20 million for five years. ExploreBio aims to invest € 1 million to € 1.5 million per company across up to four investments per year over a period of five years. The early-stage companies would benefit from quick access to funding and easy access to follow-up capital.

The four investors have worked together on investments in different companies in the past, such as Metabomed (targeted cancer therapy) and Artsavit (using apoptosis-induction to treat cancer).

With the new ExploreBio initiative, Merck and its three partners aim to engage with start-up companies in which it would otherwise be too early to invest. A second advantage for the four partners is being able to leverage the consortium’s resources and their strong relationships to work with the investments more closely and effectively.

ExploreBio complements the activities of Merck in helping early-stage companies in Israel to mature. The company set up PMatX last year and has been running its BioIncubator in Yavne since 2011.

PMatX addresses the topic of next-generation electronics and is a joint endeavor with Flex, San Jose, California, USA, and also backed by additional industry partners including HP, Palo Alto, California, USA, and the U.S.- based global investment firm Battery Ventures. PMAtX is supported by the Technology Innovation Lab program of the Israel Innovation Authority (IIA). The overall investment volume of the program involving all parties is around € 20 million and the initial commitment is for three years.

The site of Merck in Yavne houses the company’s Healthcare and Life Science incubator called BioIncubator. This successful undertaking was started in 2011 and has committed to invest up to € 10 million until 2018 in biomedically focused start-up companies in Israel.

Merck employs more than 300 people in Israel, mainly scientists, and has sites in Yavne, Herziliya, Rehovot, and Jerusalem. All three of itsbusiness sectors, Healthcare, Life Science and Performance Materials, have R&D sites in Israel.

The company also announces today that the Israel Patent Office as well as the Korean Intellectual Property Office have each issued notices granting patent applications of Merck KGaA, Darmstadt, Germany, for its CRISPR technology used in a genomic-integration method for eukaryotic cells. These decisions mark the fifth and sixth patent allowances for the unique CRISPR technology of Merck KGaA, Darmstadt, Germany, following Singapore, Australia, the European Union, and Canada. Merck KGaA, Darmstadt, Germany, also has patent filings for its insertion CRISPR method in the United States, Brazil, China, India, and Japan.

Aptar Pharma to Exhibit Innovative Drug Delivery Devices at Pharmapack 2018 in Paris, France

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Aptar Pharma, a leading drug delivery systems provider, will once again be a key exhibitor at Pharmapack 2018, Europe’s dedicated pharmaceutical packaging and drug delivery event, which takes place on February 7-8 at Paris Expo, Porte de Versailles, France.

 

Aptar Pharma’s booth, located at Hall 7.1, Booth B24/B26, will present their diverse portfolio of drug delivery solutions and will showcase their latest technology innovations. A dedicated connectivity hub will center on the field of connected healthcare solutions, a significant megatrend, which can greatly improve patient behavior and adherence.

Pharmapack provides invaluable insight into the latest trends, developments and regulatory changes impacting the industry, as well as a wide variety of learning opportunities. This year, three of Aptar Pharma’s experts have been selected to share their specialist knowledge during Pharmapack.

Gerallt Williams, Director – Scientific Affairs at Aptar Pharma, will present Opportunities and Challenges of Drug Delivery Via the Nasal Route, on February 8 at 10.00 am in Conference Room 741.  Dr. Williams’ talk is part of Conference Session 3: How will New Drug Delivery Solutions Revolutionize Patient Life and Improve Treatment Adherence?

Arnaud Fournier, Senior Business Project Manager – Injectables will present a Learning Lab on February 7 at 11.30 am at Booth H2.  His talk, Setting the Standard for Film Coated Stoppers with an Unrivalled Reduction in Particulates will discuss injectable drug trends given today’s stricter regulatory requirements. With more sensitive drugs being developed, Mr. Fournier will share insight into the need for tighter quality standards and coated packaging solutions such as Aptar Pharma’s PremiumCoat™ coated stopper, which offers an unrivalled reduction in particulates.

Sai Shankar, Director Business Development – Connected Devices, will present a Learning Lab entitled Driving Better Patient Outcomes with Connectivity on February 7 at 15.50 at Booth H2. Mr. Shankar will discuss how patient behavior can be changed through connective, intuitive, user-friendly devices, which can significantly increase does adherence and improve patient health outcomes. He will also feature Aptar Pharma’s connected device portfolio which covers Application Fields such as Respiratory and Eye Care.

Aptar Pharma will also be a selected exhibitor on Pharmapack’s guided Innovation Tours on Thursday, February 8, at 10.30am at the Innovation Gallery. The Innovation Tours take visitors on a tour of highlighted exhibitors who have made innovative strides in the industry.

Visit Aptar Pharma during Pharmapack at Hall 7.1, Booth B24/B26, where their team of experts look forward to welcoming their valued customers and partners from around the world and to exchange with key opinion leaders in the industry.

With over 400 exhibitors and more than 5,000 Pharma & drug delivery professionals expected to attend Pharmapack this year, Aptar Pharma welcomes the opportunity to once again be a part of this important industry event.