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

technoflex

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

novo

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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