Aptar Pharma and Propeller Health Partner to Develop Digital Medicine Platform Across Therapeutic Areas

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Aptar Pharma, a leading provider of innovative drug delivery systems, and Propeller Health, a leading digital therapeutics company, announced plans to collaborate on the launch of a comprehensive platform to develop digital medicines for multiple therapeutic areas and diseases.

The digital medicine platform, spanning inhaled, injectable, nasal and dermal medicine delivery forms, will combine software and experiences with connected drug delivery devices to more effectively treat diseases and improve clinical outcomes for patients.

Aptar Pharma and Propeller will work together with pharmaceutical and healthcare partners to accelerate the development, manufacturing and commercialization of digital medicines for leading marketed and pipeline brands. Digital medicines can help to personalize treatments, monitor patients in real-time, detect day-to-day changes in disease condition and increase patient adherence. Key objectives are to improve patient outcomes and help contribute to lower healthcare costs.

The collaboration brings together Aptar Pharma’s decades of expertise in device development, packaging innovation and quality manufacturing with Propeller’s platform and leading experience in digital therapeutics design and implementation.

The two companies initially partnered in 2016 to develop the world’s first fully-integrated
connected metered dose inhaler (cMDI).

Salim Haffar, President of Aptar Pharma, commented, “Aptar Pharma has been providingbinnovative drug delivery systems for nearly 50 years, helping billions of patients around the world. Today, we are excited to broaden our offerings as we continue this journey towards improved patient care and clinical outcomes by growing our partnership with Propeller Health, the leader in their field of digital therapeutics.”

“Propeller draws on nearly a decade of experience pioneering digital respiratory medicines and putting them to work in healthcare organizations around the world,” said David Van Sickle, cofounder and CEO of Propeller. “We’re excited to expand our relationship with Aptar and apply our expertise to new diseases. Our end-to-end infrastructure enables fast, flexible and secure development and commercialization of digital medicines.”

Propeller and Aptar Pharma will co-market the platform, with Propeller managing the digital services and Aptar Pharma managing the device development, manufacturing and supply chain.

In addition to expanding the partnership, Aptar Pharma has made a strategic equity investment of $10 million in Propeller Health during their latest funding round.

Tekni-Films introduces SBC 240 performance-oriented super-barrier coated thermoformable film for pharma blister packs

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A new super barrier-coated (SBC) thermoformable film for pharmaceutical blister packs is being launched by Tekni-Films, a Tekni-Plex business.

Tekni-Films SBC 240 is being positioned as a performance and improved-cost alternative for 4- and 6-mil PCTFE and cold formed foil in thermoformable blister applications. The triplex structure is ideal for applications such as pharmaceuticals, nutraceuticals, probiotics and other related products.

In addition to its desirable clear properties, SBC 240 doesn’t require stiffening ribs, which can be used to improve the ability of PCTFE to lie flat, nor the oversized blister wells created by cold forming. This means that pharmaceutical companies can use a smaller blister card to contain the same number of tablets or capsules, or increase the count on a same-sized card. The end result is material cost savings all the way through the packaging process, including cartons and cases, as well as improved production efficiencies.

SBC 240 offers ultra-high moisture and oxygen barrier properties to protect products susceptible to degradation. It also has a wider processing window than PCTFE—as much as 20 degrees Fahrenheit—which helps meet specific production speed preferences.

SBC 240 is created by applying a “next generation” high-barrier variant of polyvinylidene chloride (PVdC) coating to a film structure made from layers of polyethylene. Multiple layers can be applied to create different coating thickness weights.  As coating weight increases, so do the barrier attributes.

This latest grade is just one more example of Tekni-Film’s robust SBC thermoformable film capabilities. The company also offers 120-, 150-, 180- and 210-gram coating thicknesses, as well as other custom solutions.

Almac Group Receives Recognition at The Irish Laboratory Awards with Laboratory Supplier of the Year Award

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Almac Group, the global contract development and manufacturing organisation has announced it has won the Laboratory Supplier of the Year Award during this year’s Irish Laboratory Awards, presented by Business River. This award recognises BioClin Research Laboratories’, a Member of the Almac Group, commitment to delivering the highest quality analytical services to its customers and clients.

The Irish Laboratory Awards spotlight excellence and achievement in the laboratory environment, covering management, innovation, collaboration, personnel development and laboratory equipment supply. The winners were revealed at a ceremony on 19th April at Ballsbridge Hotel in Dublin. An independent panel of recognised and expert judges, representing Ireland’s scientific sector, determined the 2018 winners.

Judges awarded this based on the excellence demonstrated as a service provider, delivering “best in class” solutions to the pharmaceutical industry. Five additional companies were finalists for each category, as part of over a hundred nominees competing for twenty-two individual category awards.

Stephen Barr, President & Managing Director, Almac Sciences, commented: “I’m proud of our employees who work daily to provide unparalleled service to our customers and clients throughout the world. This award serves to highlight our team’s dedication and commitment to quality, and also showcases our diverse ability to deliver pharmaceutical, bio science and laboratory supplier services to the industry.”

Launched in 2013, The Irish Laboratory Awards has established itself as the premier event in Ireland for benchmarking those that demonstrate excellence, best practice and innovation in Ireland’s laboratories. These awards are an opportunity to showcase a company’s extensive knowledge, enthusiasm and expertise in the industry.

TPE compounds grow in importance as viable option for medical applications

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Recent regulatory and market drivers, including cost pressures, are generating a material choice debate about polyvinyl chloride (PVC), thermoplastic elastomer (TPE) and rubber materials, according to Colorite, a Tekni-Plex business unit specializing in custom medical-grade compounds.

Many companies are trying to proactively address new regulatory dynamics, both in the United States and in many other global regions. Pressure is being applied by healthcare systems that are already implementing strategic initiatives for phthalate-free patient environments. TPEs are being viewed as a replacement for PVC in applications where phthalate- or plasticizer-free materials are desired. Globally, IV therapy producers are among the first in the medical device industry to transition from PVC to TPE materials.

More recently TPEs also have been used to improve ergonomics, protection and/or function. TPEs are ideal for overmolding which provides a softer touch and improved ergonomics (such as grip) for a variety of surgical tools and devices. This can improve instrument control and fatigue reduction during long procedures for medical professionals.

Colorite’s Cellene® line of TPEs are suitable for a wide variety of uses in medical devices, packaging and other regulated markets. Cellene® compounds are formulated to be silicone, latex, phthalate, halogen and PVC-free using FDA-compliant raw materials to meet USP Class VI and ISO 10993 standards.

Discover the last issue of Flexmag from Technoflex, a webmagazine dedicated to injectables

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After more than two centuries of improvements, injectable drugs have brought many advances to medical treatments. This progress has been achieved in collaboration between the medical, hospital, pharmaceutical and industrial sectors. One of the difficulties is that injectable molecules which are sensitive or unstable in a reconstituted medium, are recommended in many treatments. To make them easier to reconstitute and administer, our teams have designed and developed a double chamber bag which allows the main active ingredient in the form of a powder or lyophilizate and the associated diluent to be packaged together, thus facilitating the extemporaneous preparation of the infusion.

Link to Technoflex’s last webmagazine, Flexmag :

https://www.technoflex.net/en/flexmag/flexmag-12/ 

Almac Group Expands US Specialised Commercial Packaging Capabilities

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Almac Group, the global contract pharmaceutical development and manufacturing organisation, has announced that it has expanded its US commercial packaging capabilities at its Audubon, PA facility.

Addressing increased client demand of developing and bringing more advanced medicines and niche orphan drugs to market, Almac Pharma Services has enhanced its offering by adding bespoke technology for the specialised packaging of complex kit assembly for medical devices, combination products and biologic packs.

The innovative semi-automated packaging system (SAPS) was tailor designed, built and installed by Almac’s in-house engineering team providing a best-in-class packaging solution for medical device kits and parenteral delivery forms.

The SAPS line provides a streamlined and efficient semi-automated process for the packaging of complex medical kit components and can process both standard and custom syringes, as well as auto-injector pens and any other medical devices. The highly customisable technology can operate to various scales, allowing for a variety of pack formats from sample kits to marketing packs in addition to multi-product dosage packaging.

Ensuring quality is guaranteed throughout the process, the specialised packaging line has multiple state of the art vision systems providing 100% automated verification and rejection of all components, ensuring variable data correctness, full colour recognition and medical kit completeness.

Graeme McBurney, President and Managing Director of Almac Pharma Services commented “Almac continues to invest in, and expand upon, our US commercial packaging capabilities. The introduction of this specialised technology not only enhances our existing US commercial labelling and packaging capabilities, but provides an efficient and cost effective semi-automated packaging solution to meet the evolving packaging needs of our client partners.”

Sanner CR packaging: maximum security, easy to handle

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Child-resistant (CR) packaging can help prevent unintended child poisoning and save lives. In the pharmaceutical industry, many drug producers do not want to wait for continent-wide or even worldwide regulations. Instead, they are already actively looking for suitable solutions. However, it is not always necessary to develop a completely new concept.

Small modification, large effect

Experienced suppliers like German closure specialist Sanner can help pharmaceutical companies optimize their existing packaging solutions with only a small modification. Sanner disposes of long-term market experience and has transparent production and quality management processes installed, which ensure regulatory compliance, as well as comprehensive documentation and reproducibility of the CR features.

Combination of strength and cognitive component

When developing CR packaging, two aspects should be taken into account – purely “mechanic”, that is force-related safety, as well as the cognitive component. On the one hand, a learning effect is required, for instance when a closure can only be opened through a certain sequence of movements. On the other hand, the force needed to open a package is just as important.

Apart from the push/turn version commonly used for large tablet containers in North America, there are numerous further possibilities to make primary plastic packaging child-resistant through a combination of movements, like the “press-in push-up®” mechanism of Sanner’s CR-FlipTop. This innovative packaging for tablets and capsules with an integrated desiccant mechanism combines maximum child safety with easy handling and a cap design that attracts attention at POS.

“As easy as possible, as difficult as needed”

This motto brings it to the point: CR packaging should be designed to protect children from unintentional ingestion of medication, yet at the same time it must ensure that patients have easy access to the content. Especially for senior citizens, easy handling of the opening and closing mechanism is paramount.

For instance, two pressure points that are incorporated into the closure enable grown-ups to easily open this self-explanatory packaging. Children, however, find it difficult, especially because the push movement is followed by a tipping movement. This way, relatively simple changes to a packaging can ensure additional safety. In the past years, Sanner has developed a number of solutions and introduced them to the market. They not only show how important child-resistant packaging is. They also prove that safety and user-friendliness can be combined without much effort.

Tekni-Plex granted patent for first-of-its-kind Sniff Seal technology

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Tekni-Plex has been granted a patent for its Sniff Seal® technology which is the first liner to enable scent permeation through an induction seal closure liner without affecting the seal or compromising the contents.

Brand owners are constantly looking for ways to create product differentiation. Consumers are also interested in enhancing their purchasing experience. Sniff Seal technology is an ideal way for the consumer to experience a scent in the retail aisle without compromising the seal or the product contents. A wide variety of product categories, including food, beverage, personal care, cosmetics can benefit from the technology.

“There are many instances where consumers want to know what a product actually smells like before putting it in the shopping cart. Unfortunately, there are times when consumers peel back seals or remove fitments to experience the scent before buying. When a package is returned to the shelf in a compromised condition, it is no longer sellable. As a result, the retail industry experiences a significant amount of loss annually,” explains David Andrulonis, senior vice president and general manager, Tri-Seal, a Tekni-Plex business unit.

Sniff Seal liner technology eliminates the problem because it provides the olfactory experience without removing the seal. This means that the tamper and/or pilfer evidence remains in place and the product integrity is maintained.

An extensive range of products can benefit from this technology. Imagine being able to experience the smell of fresh peanut butter or mango-scented shampoo or spring-fresh deodorant in a retail aisle without removing a seal or a fitment? That’s what Sniff Seal brings to the purchasing experience,” Andrulonis said.

Fareva opens its new analytical building dedicated to high potent technology

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Fareva has just opened its new analytical building dedicated to high potent technology on its site of Excella, Germany, welcoming 88 working spaces. This 7 m€ investment targets to support new chemical entities registration, quality by design studies, with the ability to handle molecules with an OEL < 1 µg/m³.

It will be completed in Q2 2019 with the addition of a Gerteis roller compactor that allows to manufacture up to 30 kg batches from clinical to commercial phases for 2,5 m€. It has been designed to be certified for Europe, Japan, Korea, USA and other markets.

Fareva APIs is also competing a major investment of 25 m€ on its French site of La vallee, to manufacture OEB4 APIs. First production is expected in August 2018.

Almac Group Recognised with CMO Leadership Awards

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Almac Group, the global contract pharmaceutical development and manufacturing organisation, has announced it has been awarded CMO Leadership Awards for the sixth consecutive year.

The CMO Leadership Awards recognises top outsourcing partners, determined by feedback from sponsor companies who outsource manufacturing. Each year, the awards are presented by Life Science Leader and Industry Standard Research (ISR) during an annual award ceremony which celebrates drug development and manufacturing.

Almac Pharma Services received three awards at the prestigious celebratory event held on 21 March in New York which recognised its capabilities, overall compatibility and outstanding quality at small pharma level.

The global organisation recently announced the completion of a £20 million investment in its cold chain management capabilities with the opening of a 95,000sq ft custom built cold store facility at its global headquarters in Northern Ireland. The new facility complements Almac’s existing global drug product capabilities by boasting over 3,000 pallet spaces including -15°C to -25°C storage capacity, additional 2°C – 8°C secondary production rooms, 3PL processing areas and a custom designed clinical labelling suite.

Adam Schroeder, Director Business Development, Almac Pharma Services commented “Once again, we are delighted to receive these awards which recognises continued investment in our global capabilities and solutions. This achievement strengthens our commitment to better serve our clients, and ultimately patients worldwide, thereby maintaining our position as a global leader in the life sciences sector.