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.

Servier acquires Shire’s Oncology business to gain direct commercial access in the US

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Servier acquires Shire’s Oncology business for a total consideration of $2.4 billion, in cash, upon completion. The transaction covers the transfer of Shire’s Oncology business including in-market products ONCASPAR® (pegaspargase), a component of multi-agent treatment for acute lymphoblastic leukemia (ALL) and ex-U.S. rights to ONIVYDE® (irinotecan pegylated liposomal formulation), a component of multi-agent treatment for metastatic pancreatic cancer post gemcitabine based therapy. The portfolio also includes two early stage immuno-oncology pipeline collaborations. Servier’s products will be commercialized in the United States through a newly-created subsidiary, SERVIER Pharmaceuticals LLC. Closing is expected in the second or third quarter of 2018 after obtaining authorizations from the competent competition authorities.

“The acquisition of Shire’s oncology franchise enables Servier to meet its strategic ambitions to become a key player in oncology globally. It is a major step in the transformation of the Group, allowing us to establish a direct commercial presence in the US, as well as to strengthen our portfolio of marketed products in the ex-US territories where Servier is already present. Our goal is to bring these life-saving treatments to greater numbers of cancer patients around the world”, said Olivier Laureau, President of Servier Group. “We thoroughly look forward to welcoming Shire’s dedicated oncology teams who will join Servier after the closing.”

Flemming Ørnskov, M.D., M.P.H., Shire Chief Executive Officer, commented: “This transaction is a key milestone for Shire, demonstrating the clear value embedded in our portfolio. While the Oncology business has delivered high growth and profitability, we have concluded that it is not core to Shire’s longer-term strategy. We will continue to evaluate our portfolio for opportunities to unlock further value and sharpen our focus on rare disease leadership with selective disposals of non-strategic assets”.

Servier is already present in the United States through several agreements with private and public partners and the Servier BioInnovation office. Located in the heart of Cambridge’s global life sciences hub, this new facility, opened in February 2018, is dedicated to identifying new R&D opportunities and intensifying Business Development & Licensing (BD&L) activities in the United States.

Amgen Announces Rhode Island Will Be Location Of First US Next-Generation Biomanufacturing Plant

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Amgen has announced plans to build a new state-of-the-art next-generation biomanufacturing plant at its campus in West Greenwich, R.I. The new plant, the first of its kind in the United States, will employ Amgen’s proven next-generation biomanufacturing capabilities and manufacture products for the U.S. and global markets.

A next-generation biomanufacturing plant incorporates multiple innovative technologies into a single facility, and therefore is built in half the construction time with approximately one half of the operating cost of a traditional plant. Next-generation biomanufacturing plants require a smaller manufacturing footprint and offer greater environmental benefits, including reduced consumption of water and energy and lower levels of carbon emissions.

“Amgen has three decades of experience in biologics manufacturing, and we are proud of our track record of providing a reliable supply of high-quality medicines for patients around the world,” said Esteban Santos, executive vice president of Operations at Amgen. “We are pleased to build the first commercial scale, next-generation biomanufacturing plant in the U.S., leveraging Amgen’s capabilities and incorporating the latest technologies.”

A comprehensive evaluation of global locations was conducted to select the location. Following recent U.S. federal tax reform, which provides company incentives to invest in innovation and advanced technologies, Amgen made the decision to locate the new plant in the U.S. Rhode Island was selected based on the historical success of the Amgen West Greenwich manufacturing facility, its capabilities and talented workforce, and quality of living for staff and potential to grow. The biomanufacturing plant will be built on the current Amgen Rhode Island 75-acre campus and is expected to create approximately 150 additional highly-skilled manufacturing positions and approximately 200 construction and validation jobs.

“I am thrilled that Amgen is planning to expand and bring new, highly skilled jobs to Rhode Island and further enhance the State’s life sciences community and manufacturing expertise,” said Rhode Island Governor Gina Raimondo. “We welcome Amgen’s future health care advancements for patients around the world that will come from this new biomanufacturing plant.”

Amgen opened its first next-generation biomanufacturing plant in Singapore in 2014. This type of plant offers a highly flexible, modular design which can be replicated in future facilities, which enables Amgen to increase production capabilities reliably with greater speed, productivity and flexibility. Within the plant, the equipment is portable, smaller and disposable, which provides greater flexibility and speed when manufacturing different medicines simultaneously. This eliminates costly and complex retrofitting inherent in standard facilities and allows Amgen to respond to changing demands with increased agility, ultimately impacting the speed at which a medicine is available for patients.

“We are excited that Amgen Rhode Island was chosen as the location to build the new biomanufacturing plant,” said Tia Bush, vice president of Operations at Amgen Rhode Island. “It is a testament to our skilled, dedicated workforce and Amgen’s continued presence in Rhode Island, which will enable ongoing collaborations with local academic institutions and the broader Rhode Island community.”

The existing Amgen Rhode Island plant was licensed by the U.S. Food and Drug Administration in September 2005 and houses one of the world’s largest mammalian protein manufacturing facilities. The facility manufactures commercial and clinical bulk drug substance. Amgen has invested more than $1.5 billion in its Rhode Island site, adding more than 500,000 square feet of manufacturing, utility, administrative and laboratory space to the campus. There are 625 full-time staff members employed at the Amgen Rhode Island campus.