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

Sanner

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.

Allergan to Acquire Bonti Adding New Neurotoxin Programs to Medical Aesthetics Pipeline

Bonti

Allergan has announced it has agreed to acquire Bonti, Inc., a privately held clinical-stage biotechnology company focused on the development and commercialization of novel, fast-acting neurotoxin programs for aesthetic and therapeutic applications.

Following completion of the acquisition, Allergan will obtain global rights to Bonti’s pipeline consisting of two botulinum neurotoxin serotype E (BoNT/E) programs currently in Phase 2 development, EB-001A (aesthetic) and EB-001T (therapeutic). The active ingredient in both programs, EB-001, is a novel botulinum neurotoxin serotype E (BoNT/E) with a unique clinical profile, characterized by a rapid onset of action within 24 hours and a 2 to 4-week duration of effect. Bonti recently announced topline results of the first clinical study of EB-001 in glabellar frown lines. The study confirmed both the safety and efficacy of the differentiated profile.

In the U.S. there are currently approximately 65 million consumers who are considering facial injectable treatments, including some who may be interested in being treated with a faster acting shorter-duration product.

“The acquisition of Bonti is a strategic investment for the future of our Medical Aesthetics business and has the potential to enhance our best-in-class Medical Aesthetics pipeline,” said Brent Saunders, Chairman and CEO of Allergan. “With the Medical Aesthetics market vastly expanding, a fast-acting neurotoxin with a 2 to 4-week duration will be an attractive option for consumers, particularly those who are considering a Medical Aesthetics treatment for the first time.”

“We’re excited about the development and commercial prospects for our novel programs within Allergan’s leading Medical Aesthetics portfolio,” commented Fauad Hasan, CEO and co-founder at Bonti. “The promise of benefitting more consumers worldwide with our novel neurotoxin programs plus Allergan’s stature and resources in this market will help realize our team’s and investors’ aims. We could not envision a more compelling acquirer or better strategic fit.”

Allergan will acquire Bonti for an upfront payment of $195M and additional potential commercial milestone payments, subject to certain adjustments and other customary closing conditions.

Efficient Track & Trace solutions for Acino Pharma

OCS machine

Pioneer in Track & Trace

It must be possible to precisely identify and trace prescription-only medicines worldwide along the entire value and supply chain. Machine-readable codes on the packaging ensure unique product assignment for this purpose and form the basis for counterfeit-proof drugs in pharmacies. Depending on the country, the labelling requirement for Track & Trace also includes higher-level logistics units or trade levels. Track & Trace and the technology needed for it found its way to Acino several years ago. The key area apart from serialisation was having the necessary flexibility in the line – the aim being to have as much room for development as possible for the line staff. Having a presence in global markets with its own products and filling the orders of international customers are basic requirements. So it was recently necessary to find solutions that significantly simplified handling for the logistics units where throughput was higher and at the same time made it possible for the operating staff to run the lines in 24/5 operation with a manageable amount of training and a minimal amount of servicing.

TQS offers unlimited drug safety thanks to serialisation and aggregation

Having installed the WIPOTEC-OCS solutions, Acino can offer its customers both serialisation and also aggregation at several levels of logistics units. This simplifies the logistics processes because importers can capture the content of deliveries much faster. Along the supply chains of serialised drugs, aggregation makes it easier for wholesalers, repackagers or pharmacy chains to find out the contents of a box or pallet from the barcode. Aggregation also simplifies goods receipt, repackaging and shipping processes, not to mention considerably simplifying reporting and verification of products along the supply chain. Using aggregation, there is no need to physically open and check what is inside the pre-packaged shipping units. All the necessary data can be obtained in seconds by scanning the barcode, resulting in significant savings of time and resources. Bartlomiej Sedek is convinced that, “If aggregation becomes mandatory in countries in the future, we would not need to change any of our existing lines because of it.”

Semi-automatic aggregation is among the standard solutions which Acino offers its customers. Two more lines will shortly be added in Aesch. One of them will provide fully automated aggregation which will be implemented by pester pac automation GmbH with WIPOTEC-OCS. “Unlike others, WIPOTEC-OCS has come up with lots of new ideas in machine construction and on top of that also has the better team,” Sedek says, summing up the reasons for his decision.
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ConfigureFast for the easiest handling

The overall aim in Aesch was to give the operating staff on the line more responsibility, establishing a maximum operating level. ConfigureFast, the operating concept of the TQS machines, meets these requirements very well: it is used to control the transport system, coding unit, camera, checkweigher and labeller from a single software package. For the operator, this means convenient set-up and short changeover times on product change during which there is no longer any need for the usual lengthy changes to several different user interfaces. This consistency covers all levels of aggregation. ConfigureFast will enable the line staff to convert the production lines much more easily and quickly – saving Acino a lot of time. Acino’s target is 800 layouts, combined with the claim of implementing the best packaging standards in the northwest of Switzerland. And this is the sign of special quality, easy to read and easy to see: Swiss made.
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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.

CPhI & P-MEC China 2018 | Your pharmaceutical trade & networking platform

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CPhI and P-MEC China – at SNIEC, Shanghai from June 20 to June 22, is your gateway to successfully grow your business at the 2nd largest pharma market in the world. Whether you are looking for sourcing new partners of getting the latest market insights, this is your one-stop-shop platform for reaching out to the entire Chinese pharmaceutical industry.
This year over 45,000 pharma professionals will attend the 18th edition of Asia’s Premier Pharmaceutical event. 3,000+ exhibitors from over 150 countries will be showcasing their latest products, developments and innovations. The ideal place to source, learn, and match with the right parties!

Alongside the event, the 2nd edition of China Pharma Week will be held from 19 – 23 June. During this week you can enjoy numerous opportunities to connect, network, and interact with both Chinese and international attendees, elevating your event experience to a higher level.
Did you know? This year CPhI will host the 8th edition of the Buyers Sourcing Service. This matchmaking service connects international buyers with local suppliers. Establish relationships with local suppliers, and provide them with a better understanding of the international market. Apply now and submit a request; CPhI will match you with the right party for a face-to-face meeting onsite.
Attend CPhI & P-MEC China to do cost effective business in 1 location!

The event is just under 2 months away, and now is the ideal time to register to attend. Don’t get caught out by visa applications and travel arrangements: register now !


CPHI