SBC films are ideal alternative to traditional CFF and PCTFE for pharma products

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With pharmaceutical companies constantly looking for ways to improve their product packaging with performance-driven, cost-effective solutions, there is an alternative to traditional structures that is making its way into the main stream. Super barrier coated (SBC) films are now being considered for pharma and other healthcare applications.

Tekni-Films, a Tekni-Plex business, has introduced SBC 240 as a performance and improved-cost alternative for 4- and 6-mil PCTFE laminations and cold formed foil for blister applications. This thermoformable film has exceptional moisture and oxygen barrier properties and is designed to meet the needs of pharmaceutical and other healthcare applications. The triplex structure is ideal for applications such as pharmaceuticals, nutraceuticals, probiotics and other related products.

SBC is created by applying a next generation, high-barrier PVdC coating to a lamination of PVC and polyethylene. The PVdC is dispersed in an emulsion, which has been engineered as a surface coating. Multiple layers can be applied to create different coating weights. As coating weight thickness increases, the overall barrier properties also increase.

“For those pharmaceutical companies who may not be well-versed in the various attributes of SBC films, we have created performance data comparisons to CFF and PCTFE, including information on why the material lends itself to smaller pack sizes.  With material usage and environmental concerns at the forefront of every packaging decision, a smaller pack size is an important attribute to consider,” explained Melissa Green, senior director of global marketing for films.

Dual-Mix® Wins a Prize at the CPhI Pharma Awards 2018

Sans titre

Technoflex® is proud to announce that their innovation, Dual-Mix®, has received the award for Excellence in Pharma in the Packaging category. It was chosen from among more than 250 candidates across 17 categories at the 2018 CPhI Pharma Awards. Dual-Mix® is a patented dual-chamber bag designed to hold a medicine in powder/lyophilizate form and its associated diluent. It enables the packaging of unstable molecules which need to be reconstituted just before administration to the patient. “Dual-Mix® is a major breakthrough in facilitating and improving safety for nurses and for patients, making reconstitution of the right dose easy to perform, at the patient’s bedside” highlights Dr. Olivier Chesnoy, CEO of Technoflex®.

Almac Group Invests to Expand its Existing North Carolina Facility

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Almac Group hasannounced the completion of an investment in its Durham, North Carolina Clinical Services’ and Diagnostic Services’ capabilities with the opening of a 24,000 sq. ft. building.

As part of Almac’s ongoing growth strategy, this significant expansion adds a fourth building to the Durham campus and provides additional office space for more than 100 new employees over the next three years. This additional capacity complements Almac’s existing Durham facility which offers a range of end-to-end clinical trial supply solutions to clients globally, as well as Almac Diagnostic Services which provides biomarker driven clinical trial solutions.

Donna Christopher, Global Vice President of Operations, Almac Clinical Services, commented:

“Almac’s exceptional quality is demonstrated by our dedicated employees, all of whom work hard to strengthen relationships for long-term collaboration. We are delighted that this further investment in our Durham facilities enables us to continue to support our clients’ needs and meet the increased demands for our integrated services. This expansion not only provides us with a stronger ability to service our growing customer base but it also serves to demonstrate our commitment to being the most trusted and stable name in the clinical supply marketplace.”
This expansion of service capacity comes shortly after the conclusion of Almac’s previous $5.2 million investment at the North Carolina facility in 2016, which saw the expansion of its Clinical Services operations along with the development of its Diagnostics and Clinical Technologies services. In its fifth decade of operations – with over twenty of these in North America – Almac’s commitment to be the partner of choice providing an array of innovative clinical solutions worldwide continues with ongoing expansion plans in development.

ARaymondlife and DARA were exhibiting the NFL line, compatible with RayDyLyo® plastic caps, during the last  CPhI at Madrid

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RayDyLyo® a breakthrough innovation with multiples benefits

RayDyLyo® is an all-plastic capping solution designed to work with all ISO stopper configurations (serum and lyo). Customers select and validate the stoppers which are assembled automatically by ARaymondlife. Pre-assembly of the stopper in the RayDyLyo® cap upstream simplifies the vial capping process to one-step in the isolator and eliminates the constraints associated with the crimping of aluminum caps.

 

A new filling line adapted to work with the RayDyLyo® cap is being presented at CPhI Madrid

In 2017, the Spanish company Dara Pharmaceutical Packaging worked closely with ARaymondlife to adapt its SX-310 filling line to work with RayDyLyo® closures. Equipped with a single vibratory bowl, the SX-310-RDL line has a reduced footprint compare to conventional lines, whilst maintaining quality standards.
Convinced by this first success, DARA and ARaymondlife decided to modify a new line for processing RayDyLyo® plastic push fit caps.

The NFL line is a line dedicated to the filling and capping of ready to use (RTU) nested vials, cartridges and syringes. This very compact machine requires no washing unit, no sterilization tunnel and no crimping station.

“A year ago, we worked with Dara to modify the SX-310 line for processing RayDyLyo® caps. Today, we are pleased to have achieved this same goal with the NFL line, so proving the ease of implementation of our RayDyLyo® solution for pharmaceutical companies,” says Pascal Sircoulomb, Business Development Director
of ARaymondlife.

With a filling and closing capacity of 4800 vials per hour, the NFL line offers a leading technical and economic solution for pharmaceutical companies and biotech companies looking for the flexibility to manufacture from small batches up to industrial series.

“Modifying our equipment to work with RayDyLyo® plastic caps was quick and easy, thanks to the close collaboration with ARaymondlife” says Joan Mele, Commercial Director at Dara Pharmaceutical Packaging. “Today we are able to offer a compact and multi format machine that makes it possible to close vials in one step, without de-nesting, in an aseptic area thanks to RayDyLyo®.”

“ARaymond is a large quality-orientated company that is always looking for long-term results, which is very important for making the investments
needed to achieve our goals. We share a common philosophy with them in terms of innovation and added value “says David Ral, General Manager of Dara.

The goal of DARA and ARaymondlife is to set up around 20 NFL filling lines over the next 3 years. Two machines are already functional and available immediately.

“We are confident that facilitating the implementation of RayDyLyo® on existing machines in the market, coupled with its many other economic and quality advantages will make our plastic capping solution, the new standard for vial capping” concludes Nicolas Thivant, President of ARaymondlife.

Amgen Invests £50 Million ($66 Million) In Oxford Nanopore Technologies

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Amgen and Oxford Nanopore had announced Amgen’s equity investment of £50 million ($66 million) in Oxford Nanopore, a privately-owned, UK-based company advancing a new generation of portable, real-time genetic sequencing technology.

Oxford Nanopore has developed and brought to market a proprietary sequencing technology that uses many nanopores (nano-scale holes made by proteins contained within a synthetic membrane) in combination with electronics to perform direct, real-time sequencing of DNA and RNA. The technology ranges in scale from pocket-sized to very high throughput benchtop devices and can sequence very long fragments of DNA or RNA, which has a number of benefits in genomic analysis.

The investment in Oxford Nanopore aligns with Amgen’s strategic focus on using human genetics to deliver new medicines to patients. Amgen subsidiary deCODE Genetics, a world leader in human genetics, uses Oxford Nanopore’s sequencing technologies to conduct genome research, including the identification and validation of new targets.

“The study of human genetics continues to uncover insights into the diseases we face as a society,” said Kári Stefánsson, founder of deCODE Genetics. “Oxford Nanopore’s long-read sequencing capability creates a window into parts of the genome that have been out of reach, as well as giving us a much better handle on structural variants that confer risk of a wide variety of diseases. We have used Oxford Nanopore technology to sequence several hundred human genomes and continue to see the promise of this emerging technology.”

“As a biotechnology pioneer, Amgen has demonstrated what can be achieved for society through innovation and a deep understanding of genetics,” said Gordon Sanghera, chief executive officer of Oxford Nanopore. “We are delighted to welcome them as a shareholder.”

Nanopore technology is uniquely scalable. MinIONTM, the only pocket-sized sequencer, can be used to sequence in any location. In addition, Oxford Nanopore has developed benchtop, on-demand, high-throughput devices such as PromethIONTM designed for very large projects or large numbers of samples.

AstraZeneca strengthens and expands oncology development and commercialisation collaboration with Innate Pharma

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AstraZeneca, and its global biologics research and development arm MedImmune, announced a new multi-term agreement with Innate Pharma (Innate), building on an existing collaboration, aimed at accelerating each company’s oncology portfolio and bringing new medicines to patients more quickly. The extended collaboration will enrich AstraZeneca’s immuno-oncology (IO) portfolio with pre-clinical and clinical potential new medicines.
AstraZeneca will obtain full oncology rights to the first-in-class humanised anti-NKG2A antibody, monalizumab, expanding its partnership with Innate from the initial collaboration announced in 2015. AstraZeneca also gains option rights to IPH5201, an antibody targeting CD39, as well as four preclinical molecules from Innate’s pipeline. Innate is licensing the US and EU commercial rights to recently FDA-approved Lumoxiti (moxetumomab pasudotox) for hairy cell leukaemia (HCL).

Pascal Soriot, Chief Executive Officer, said: “Our expanded collaboration with Innate Pharma enables us to further strengthen our leadership in immuno-oncology, and to explore the potential of next-generation immuno-oncology pathways, together with the world-class scientific team of Innate. Today’s agreement also secures the long-term commercialisation of the recently FDA approved rare disease medicine, Lumoxiti, through dedicated focus and investment by Innate Pharma.”

Mondher Mahjoubi, Chief Executive Officer of Innate Pharma, said: “Today is a defining moment for Innate Pharma as we transition to become a fully-integrated oncology-focused biotech. Lumoxiti is a major therapeutic innovation for patients who suffer from relapsed/refractory hairy cell leukaemia, and we are proud to be in a position to address a significant unmet medical need. Our commercial team will be focused on rare cancers and generate more value as our own haemato-oncology proprietary pipeline develops.”