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

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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.”

Dual-Mix®, the innovative solution for error-free reconstitution

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Drugs which are unstable in solution have, until today, been packaged in powder or lyophilizate form in glass bottles. They then need to be reconstituted at the patient’s bedside, or in the hospital pharmacy, in aseptic conditions. There are many errors and accidents linked to reconstitutions which pose a real risk for patients and healthcare personnel: errors with diluents, dosage errors, needle stick injuries*, contamination, etc. To reduce these risks, Technoflex has developed Dual-Mix®, an innovative primary packaging which meets three challenges: storing the drug to be reconstituted, making its reconstitution secure and ensuring the safety of healthcare staff and the patient.

Dual-Mix® is a patented bag which contains a medicine in powder/lyophilizate form and the associated diluent in the same dual-chamber primary packaging. It facilitates and makes safe the packaging of very unstable molecules which need to be reconstituted just before administration to the patient. Designed in Inerta® polypropylene, the material in contact with the main active ingredient and the diluent is fully compliant with European and American pharmacopoeias.

The bag is delivered sterile and consists of a lower chamber for the diluent and an upper chamber for the main active ingredient. The latter is the component which requires the highest protection. So, a peelable aluminium label, which can be placed on both sides of the bag, protects the powder or the lyophilizate from light and humidity. It is easy to remove at the time of use, and the nurse can very simply check the integrity of the product before its reconstitution.

The two chambers are separated by a peelable seal. It is sufficiently hard wearing not to break spontaneously during transport or storage, but is however easy to break by using simple appropriate pressure on the lower chamber to ensure that the main active ingredient and its diluent are mixed just before infusion. Reconstitution is achieved in under 10 seconds and in a totally safe way. The bag’s closed system ensures that the product is sterile and avoids risks of contamination during handling. Finally, Dual-Mix® has a twist-off compatible with the majority of spikes and infusion sets used in Europe and the United States.

Dual-Mix® is available in three different volumes of 50, 100 and 250ml and opens the way for standardized ready-to-use doses of drugs. By avoiding the need in some cases for preparation in the hospital pharmacy, Dual-Mix® optimizes preparation and administration by medical staff. A not inconsiderable advantage and a great advance, making reconstitution and administration simple, fast and totally safe in a hospital environment, but also during hospitalisation at home or in emergency or conflict zones.

* In the United States, 1000 people, 58% of whom are nurses, are affected every day by needle stick injuries, generating $1 billion in extra costs. (Source: Becker Hospital Review)

Sanner expands production in Hungary

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Sanner is consist-ently expanding its manufacturing activities in Hungary. By upgrading and optimizing the machinery park, the company is opening up capacities for new products and additional jobs. This is an important step in the integration and positioning of the Sanner group’s European production sites.

Sanner Hungária Kft is set for further growth: during the past months, the company has laid the technical foundations for an expansion of production by continually optimizing the existing capacities. Soon, further injection molding capacities will be available for new products. Sanner further plans to manufacture the desiccant cap-sules AdCap® at both sites in Bensheim and Budapest. Moreover, extending the automated, camera-based final inspection adds to an increase of efficiency in qual-ity management. “All these steps strengthen the position of the Hungarian site within the Sanner group,” explains Volker Pfitzenreiter, head of production Europe at Sanner.

Close integration of European locations

Sanner Hungária Kft was established in 1995 and has become the second, equally qualified European manufacturing site of the Sanner group. The GMP-compliant, SAP-controlled production is certified according to ISO 9001, ISO 15378 and BRC. The close integration with production at the headquarters in Bensheim with regard to technology, production planning and optimization processes pays off for the en-tire Sanner group: each year, a production volume of roughly five million Euros is realized in Hungary, two thirds of which are exported to other European countries.

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Teamwork is key to success
To ensure that customers always receive packaging solutions in the usual high Sanner quality, the team from Sanner Hungary not only relies on the good collaboration across production sites. In the own manufacturing facility, a close cooperation of the different divisions is just as important, for instance during the daily shopfloor management meeting. “A positive error culture and actively involv-ing the employees in the continuous optimization process is paramount,” Pfitzen-reiter says. “Only as a team can we achieve our growth goals and advance the location expansion in a positive working atmosphere. Due to the significant restruc-turing and optimization process, we are currently also looking for new colleagues, who want to become part of the Sanner team in Budapest.”

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Micro pump for Parkinson’s treatment from Gerresheimer subsidiary Sensile Medical receives European CE declaration of conformity

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A wearable micro pump from Sensile Medical has received EU certification for the European market. A European pharma company has obtained a CE declaration of conformity for the pump, which is specially designed for the treatment of Parkinson’s disease, and is now bringing it to market. This is the first time a micro pump from Gerresheimer subsidiary Sensile Medical has come into commercial use.

The micro pump is used in the treatment of advanced Parkinson’s disease. Its great benefit for patients relates to ease of use, including features such as automatic filling with liquid medicine. State-of-the-art technologies such as a color display, charging unit and data storage help enhance therapy management. The handy-sized, discreet pump comes with a leather bag for it to be worn on the user’s belt.

A prerequisite for market launch was the CE declaration of conformity for medical devices. Now it has that, the pharma company can bring the pump to market. Sensile Medical developed the micro pump for Parkinson’s disease treatment especially for the pharma company concerned. It is one of currently five concrete customer projects in various therapeutic areas.

“The CE declaration of conformity and market launch for the first micro pump, in this case for Parkinson’s treatment, marks a key milestone for our subsidiary Sensile Medical. The deservedly strict approval standards for patient-critical delivery systems of this kind are now satisfied and market launch can begin. We are correspondingly optimistic regarding further application areas for Sensile Medical’s micro pump technology,” explained Andreas Schütte, Member of the Management Board of Gerresheimer AG.

A personally programmable basal profile enables treatment to be optimized for Parkinson’s patients and ensures that they receive the precise dosage they need. Likewise for the bolus rate: A patient can cause the device to deliver a bolus at just one touch of a button. Sensile Medical’s patented SenseCore micro rotary piston pump at the heart of the pump device ensures exceptionally safe, precise drug delivery. An even greater level of safety is attained by eliminating flow rate calculations.

“In developing the micro pump for Parkinson’s treatment, we have completed a highly ambitious project to exacting requirements that improves treatment for patients. The device also comes with a large number of different languages already on board, enabling its use in many countries around the world,” explained Derek Brandt, CEO of Sensile Medical AG.

Novo Nordisk announces plans to transform its approach to Research & Development

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Novo Nordisk has announced plans to restructure its Research & Development (R&D) organisation to accelerate the expansion and diversification of its pipeline across serious chronic diseases. To enable increased investment in transformational biological and technological innovation within both core and new therapy areas, approximately 400 employees will be laid off from R&D roles in Denmark and China.

To support its strategic ambitions, Novo Nordisk will establish four Transformational Research Units in 2018 to pursue novel treatment modalities and platform technologies. The biotech-like units, based in Denmark, the US and the UK, will operate as satellites of Novo Nordisk’s central R&D function and will drive innovation in priority fields such as translational cardio-metabolic research and stem cell research.

Furthermore, to drive a faster and more efficient path towards lead molecule selection and development, Novo Nordisk will significantly increase its investment in automation and digital capabilities including machine learning and artificial intelligence (AI). The integration of laboratory infrastructure and IT systems will also be prioritised to increase the efficiency of the R&D organisation.

“Delivering on our ambition of achieving even higher levels of innovation across a broader and more diverse range of chronic diseases requires that we have the optimal future skill base and allocate resources to our priority areas,” said Mads Krogsgaard Thomsen, chief science officer, Novo Nordisk. “Unfortunately, this implies that a number of valued colleagues will lose their jobs in order to ensure that we have sufficient new research capabilities needed to support our long-term growth ambitions.”

The restructuring and re-allocation of resources supports Novo Nordisk’s ambition to transform the way it works within R&D in order to identify and develop truly innovative drug candidates. This will be facilitated by the identification and pursuit of new therapeutic approaches based on external collaborations – a priority that Novo Nordisk will accelerate via the establishment of a new Business Development unit in Cambridge, MA, US.