Metsä Board Launches Its Unified Offering of Products and Services

Metsa

The Better with Less initiative highlights the company’s aims to improve consumer experience and make packaging even more sustainable

Metsä Board has launched its clarified product and service portfolio on May 4th at Interpack in Düsseldorf. The company presents its offering of premium paperboards and related services, with focus on contributing to even more sustainable, safe and efficient packaging, now found under one Metsä Board family.

The Better with Less initiative showcases Metsä Board’s aim to create, together with its customers, considered and innovative, renewable contemporary packaging solutions fitting brands and demands of the future world.

“Consumers expect better experiences with less environmental impact. Brand owners are looking at how to optimise packaging to be more sustainable, safer and lighter in weight. We are known for our pioneering expertise in high-quality, lightweight paperboards and are committed to improving further. Now with our unified product portfolio and targeted services we can provide even stronger support to our customers to jointly improve sustainability and efficiency of packaging throughout the value chain,” says Mika Joukio, CEO of Metsä Board.

As part of the launch Metsä Board renews the product names of its premium quality lightweight paperboards to bring the offering to customers in a clearer way that makes product selection even easier. The three service areas – Packaging Analysis & Design, Availability Services and Technical Expertise and R&D – complement the products and provide collaboration initiatives for joint development with customers to develop better and lighter packaging.

While the company’s offering and product names will be harmonised, the products and their specifications will remain unchanged. All Metsä Board mills hold PEFC™ and FSC® Chain-of-Custody certificates, as well as the highest environmental and manufacturing quality standards. Metsä Board’s paperboards use fresh forest fibres from sustainably managed northern European forests.

The “BB Dose”: a Unither innovation that guarantees more safety with the infant

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Unither Pharmaceuticals is the world leader in the production of sterile single-unit dosage forms using the Blow-Fill-Seal (BFS) technology.

Since 1993, Unither Pharmaceuticals has been conducting various studies to better meet laboratories needs and thus facilitate patient medication intake. The new system brought by Unither, called “nose project”, does not damage the baby’s nose.

One of the studies conducted by UC/Consultants focuses on the use of physiological serum on infants. We found that mothers perceive the “physiological serum” as a neutral water, with a neutral pH, which does not necessarily contain antiseptic; Or a liquid such as blood. As for its use, the mothers always operate with a defined ritual, which shows their involvement around the product. Their expectations are very strong: the mothers are paying attention to every detail. The fear of hurting the baby with the (badly cut) tip and the risk of injury inside the nose remain present when using physiological serum.

Recently, Unither Pharmaceuticals partnered with Biolane to developed a single-unit dose featuring a more rounded tip that fits perfectly with babys’ nostrils. The “BB dose” guarantees a greater safety of the gesture of the mother with the infant. And avoids to skin him during the use of the physiological serum.

In addition to that, BFS technology enables the manufacture of preservative-free single-unit doses. Preservatives are recognized as potentially harmful to the sensitive mucosae of the eyes, nose, and lungs, so this is an enormous benefit to sensitive patients such as infants. Another advantage of unit-doses is that they are portable and easy to use individually, excellent properties for today’s active lifestyles.

Catalent Provides Commercial Manufacturing Of Lexicon Pharmaceuticals’ Orphan Drug XERMELO™ Following FDA Approval

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Catalent Pharma Solutions recently welcomed Lexicon Pharmaceuticals, Inc.’s announcement that its pioneering orphan drug, XERMELO™, has been approved by the U.S. Food and Drug Administration (FDA). Catalent has been working in partnership with Lexicon since 2007 to develop the drug formulation, and will be manufacturing XERMELO for commercial supply.

XERMELO (telotristat ethyl) 250 mg is a first-in-class orally administered therapy for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.

“We are pleased that the skill and expertise that our scientists have dedicated to this project for ten years has resulted in this pioneering treatment reach the market,” commented Matthew Mollan, Catalent’s General Manager at its Kansas City, Missouri site. “Catalent first partnered with Lexicon when the drug was in Phase I development, and continued to support its manufacture through to supplying launch products.”

“We are proud to have discovered this ground-breaking orphan drug, and our successful collaboration with Catalent means we are now able to make it available for the thousands of patients currently suffering from this condition,” added Lonnel Coats, Lexicon’s president and chief executive officer.

Carcinoid syndrome is a rare condition that occurs in patients living with metastatic neuroendocrine tumors (mNETs) and is characterized by frequent and debilitating diarrhea that often prevents patients from leading active, predictable lives, as well as by facial flushing, abdominal pain, fatigue and, over time, heart valve damage.

Catalent undertook development and manufacture of the drug at its 450,000-square-foot Kansas City facility, where the company provides a range of fully integrated support services, from formulation development and analytical testing, to clinical and commercial scale manufacturing and packaging of various oral dose forms.

Aptar Pharma’s Electronic Lockout Device Approved by EMA

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Aptar Pharma, a world leader in innovative drug delivery systems, is pleased to announce the approval by the European Medicines Agency (EMA) of the first integrated electronic nasal lockout device (e-Lockout) following a multi-year development with Takeda Pharmaceuticals International AG. Aptar Pharma agreed to supply Takeda with its e-Lockout device for a multidose nasal spray version of Instanyl®. The EMA has granted marketing authorization for this multidose nasal spray treatment under the name Instanyl DoseGuardTM.

This represents a major milestone for Aptar Pharma, with the e-Lockout device being the first and only fully integrated electronic nasal drug delivery device to be approved by a U.S. or European regulatory authority.

Already available in unidose and multidose nasal spray versions, Takeda will launch Instanyl® DoseGuard in Europe in several multidose strengths, all using Aptar Pharma’s patented electronic lockout system, which marks another product innovation in the management of breakthrough pain.

Advanced e-Device Technology Ensures Safe Compliance

Instanyl® is a fast-acting nasal opioid approved for relieving breakthrough pain in adult cancer patients already treated with opioids for their usual pain. Breakthrough pain is an additional sudden pain that occurs despite having taken one’s usual pain relieving medicines.
Aptar Phama’s e-Lockout device uses advanced electronic technology to help patient compliance in the treatment of chronic disease. Aptar Pharma’s e-Lockout device is intended to ensure safe patient compliance by limiting the number of doses available during a 24 hour period.

The system’s built-in lock-out mechanism prevents the device from being used for a period of time after a pre-defined number of spray actuations. The electronic display shows the number of priming strokes, the number of doses left in the device and whether the nasal spray is locked or ready for use. The e-Lockout also features a child-resistant cap.

Long-term Strategic Partnership with Takeda

The multi-year supply agreement reinforces a long-standing partnership between Takeda and Aptar Pharma, who currently supplies Takeda with unidose and multidose nasal spray devices for Instanyl® in Europe.

Committed to accompanying pharmaceutical companies throughout their product lifecycle management, Aptar Pharma continues to partner to provide customers with innovative and smart solutions to enable safe, convenient and compliant medication delivery.

“This approval and subsequent product launch underscores Aptar Pharma’s ability to partner with the pharma industry to bring innovative, compliant and safer devices through the regulatory authorization process,” explained Salim Haffar, President, Aptar Pharma. “This is yet another example of Aptar Pharma’s expertise and technology at the heart of a new market launch. This is a significant step in strengthening Aptar Pharma’s credentials in the electronics and connected health markets. We are pleased to be building on our trusted, long-term partnership with Takeda,” he added.

Aptar Pharma Partners with Kali Care to Develop Real-Time Medication Management Technology

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Aptar Pharma and Kali Care have announced that they entered into a partnership in order to address the challenge of monitoring adherence in ophthalmic clinical trials. The combination of Aptar Pharma’s ophthalmic device expertise, and Kali Care’s ground-breaking digital monitoring system for ophthalmic medications, is likely to have a significant impact in reducing the costs and complexity of ophthalmic clinical trials.
Kali Care, a Silicon Valley-based technology company, provides a revolutionary sensor technology which allows clinicians to replace adherence assumptions in clinical trials with collected real-time data.
This represents the latest step for Aptar Pharma in the development of drug delivery devices and collaborations in the connected health space.
Combining the Silicon Valley Spirit with Proven Expertise in Drug Delivery Systems
Aptar Pharma has been setting the standard for the drug delivery industry for decades. This strategic collaboration once again underlines the company’s continuous efforts in breaking new ground in innovative healthcare technologies.
Sina Fateh, MD, Founder and CEO of Kali Care, explained that because Aptar Pharma is well-respected for its proven regulatory expertise, this will help his company move forward through approval and compliance processes.
Aptar Pharma’s ability to support complex projects and meet the challenging and changing regulatory requirements was recently demonstrated by their collaboration with Allergan on launching the first FDA-approved prescription preservative-free ophthalmic multidose product (Restasis MultiDose™).

Meeting the Needs of Patients and Clinicians
Using eye drops as a drug delivery system has its own set of challenges which must be recognized and addressed at the clinical level. Clinical trials benefit from more accurate and timely data collection and management.
For ophthalmologists, the ability to see the medication adherence score of patients with glaucoma is a powerful tool in managing treatment plans.
Enhancing Clinical Information
Kali Care has developed the first digital monitoring system for ophthalmic medications. Kali Care’s monitoring technology integrates smart sensors, data analytics and cloud services.
With soaring clinical trial costs and complexity, the biopharmaceutical industry is constantly seeking new approaches to improve efficiency and productivity. In clinical trials, the Kali Care system replaces usage assumptions and self-reporting related to medication adherence. This can result in shorter and more efficient clinical trials. The Kali Care Adherence Score provides critical information for explaining the incongruity between recommended treatment and actual treatment outcomes.
Staying Ahead of the Market
Combined with the recent breakthrough of Aptar Pharma’s ophthalmic drug delivery systems, Kali Care’s revolutionary sensor technology opens new opportunities for the monitoring of patient adherence.
In a joint statement, Salim Haffar, President of Aptar Pharma, and Sina Fateh, MD, highlighted the advantages associated with combining unrivalled microbiological safety and revolutionary sensor technology, “Clinicians are now able to rely on objective and accurate data. Aptar Pharma’s leading dispensing technologies combined with Kali Care’s smart sensors, data analytics and cloud services will help make clinical trials more efficient and effective. This allows ophthalmologists to improve risk strategies to distinguish patients requiring minimal support from those who require closer monitoring.”

Nemera announces its participation in the European Project Cupido (Cardio Ultraefficient nanoParticles for Inhalation of Drug Products)

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The nano-revolution reaches the heart: the EU-funded project Cupido will foster the translation of nanomedical applications toward the cardiac field

Cardiovascular diseases, such as myocardial infarct and heart failure, represent a societal burden, accounting for more than 30% of deaths globally and spending yearly ~190 billion € in European healthcare. The chronic treatment of patients leads only to short-term benefits since the conventional therapies show several weak points.

The available drug-delivery methods, oral and intravenous, allow the drug to circulate systematically in the blood stream causing several side-effects and reducing its efficacy. Later, during the end-stages of the disease, the administration might become even more invasive, employing catheters or implantable pumps.

This highlights the urgent need to develop new patient-friendly therapeutic strategies that are more efficient, safe and heart-specific.

Nemera is proud to contribute to the EU-funded project Cupido, started in February 2017. It proposes an innovative solution: the application of nanotechnologies to the cardiovascular field. Cupido aims to hit the core of the cardiovascular disease, developing inhalable nanoparticles that can deliver as simple as breathing a therapeutic directly to the diseased heart. Nanoparticles are extremely tiny, almost 1 million times smaller than a grain of sand in size and far too small to see with conventional microscopes. Exploiting such a tiny system as a route of administration can revolutionize the cardiovascular field, becoming the first non-invasive and heart-specific therapeutic approach.

To achieve the goal, the Cupido consortium is working to develop biocompatible and biodegradable nanoparticles that can self-assemble and encapsulate drugs (novel or available) in a suitable format for the treatment of cardiovascular disease. The nanoparticles, once inhaled, will translocate through the lungs and fast reach the heart, where the drug will be finally released on the site of interest. The heart-specificity will be ensured thanks to chemical and magnetic guidance, reducing the chances of adverse side effects and lowering the required amounts of therapeutic compound.

The role of Nemera in this consortium will be the development of the devices for the administration of the nanoparticules by inhalation to the heart.

The EU-based consortium, composed of 6 academic research groups, 5 SMEs, 2 industries, and 1 pharmaceutical company, gathers a vast array of expertise and joins cutting-edge research with pre-clinical experience and industrial manufacturing. The 4-year project, funded with 6M € under the EU Horizon 2020 Framework Programme, aims to proof the preclinical feasibility of the nanotherapy, preparing the way for future clinical trials.

Consortium:

  • Nemera
  • CNR – National Research Council of Italy
  • Charité – Universitätsmedizin Berlin
  • Simula Research Laboratory AS
  • Imperial College of Science, Technology and Medicine
  • BET solution IN S.r.l
  • Cambridge Innovation Technologies Consulting Ltd
  • Sanofi-Aventis Recherche & Developpement
  • FIN-CERAMICA Faenza S.p.A.
  • L.I.F.E. Corporation S.A.
  • PlumeStars S.r.l.

Find CUPIDO on the web at www.cupidoproject.eu

Plastic injection for innovative Medical Devices

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Specialized in manufacture of thermoplastics medical device, Faiveley Plast’s Pharma division continues to grow by cultivating its policy of innovation and co-development. In particular, the division developed a single-use operating kit for foot surgery for Novastep Company.

Faiveley Plast Pharma relies on Eudica plant, based in Annecy, to support the development of its clients in orthopedics and implantology (knee, hip, shoulder or foot prostheses …). The company draws new know-hows from the wide range of solutions already offered by the Faiveley Plast group, in terms of processes such as overmoulding or the integration of electronics adapted to the medical environment, as well as plastics Innovations such as PETG, Ixef, etc.

Innovation and co-development are deeply ingrained in the company, which has resulted recently in the success of a single-use surgical kit for foot surgery for Novastep. Faiveley Plast Pharma has also accompanied another company for its range of special PET tubes and caps and several other components.

This constant quest of search for technological excellence also concerns quality with the recent addition of new services of sealing control by hyperbaric chamber and laser engraving.

The year 2017 will see new innovative applications such as the overmolding of implantable probes for medical imaging. A project that combines constraints of biocompatibility, sealing and reliability of the electronic part of the device.

To be seen on D12 booth at Intermeditech 2017.

Almac Group Announces Further Global Expansion as it Secures New Premises in Republic of Ireland

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Craigavon based global contract pharmaceutical development and manufacturing organisation, Almac Group, has secured new premises in Dundalk, County Louth to support its ongoing global expansion plans in response to increased client demand.

Almac will make a £ multimillion investment in the new facility at IDA Business Park.  The expansion has been supported by the Department of Jobs, Enterprise and Innovation through IDA Ireland, Ireland’s inward investment promotion agency.

The facility will be utilised by Almac Pharma Services and Almac Clinical Services, both of which are registered to operate in the Republic of Ireland. The new premises increases the Group’s European footprint by 32,000sq ft and provides continued presence within the European Union in the long term.

This investment comes just weeks after Almac confirmed ambitious plans to expand its operations at its global Headquarters in Northern Ireland with the construction of a new laboratory and additional office facilities. The company simultaneously announced investment at its North American site creating an additional 300 new, full time jobs. These investments will see an increase of Almac’s global headcount to over 5,000 by the end of 2017.

Alan Armstrong, CEO Almac Group commented:  “This latest investment in Dundalk is a further example of Almac’s ambitious global expansion plans and will deliver up to an additional 100 new jobs within the first two years. This news comes in addition to our recent announcement of a £27m investment at our global Headquarter site in Craigavon, our US operations and our European facility in Athlone. All of this is evidence of Almac’s commitment to provide best-in-class products and services to our clients across the world and we would like to thank all those who have supported us to date.”

Welcoming the investment by Almac, Minister for Jobs, Enterprise and Innovation, Mary Mitchell O’Connor said: “This is a very exciting project for Dundalk and builds on the strong cluster of multinational companies who have very successfully located in that town in recent years and who have found it a great base from which to promote their sales into other EU Member States.  Ireland’s expertise in the Pharma sector is unrivalled, with virtually all the major international players having operations here, thus generating synergies and opportunities for new companies investing with us. These additional 100 jobs to be provided are very welcome and we look forward to a long and mutually beneficial engagement with Almac into the future”.

Martin Shanahan, CEO, IDA Ireland said “Almac’s decision to expand into Dundalk provides the company with certainty of access to the European Union in the long term– this certainty of access is an increasingly important selling point for Ireland as we look to win business for Ireland.  IDA Ireland will continue to promote Ireland as an ideal location for companies from a range of sectors including pharmaceuticals, IT and financial services that are looking to ensure that they have a presence in the European single market.”   

This investment strengthens Almac’s existing presence in the Republic of Ireland following the acquisition of Arran Chemical Company facility in Athlone in 2015. The facility has expanded the company’s biocatalysis services, which is part of Almac’s Sciences Business Unit.

Catalent Expands Kansas City Clinical Storage & Secondary Packaging Capabilities To Meet Growing Demand For Cold Chain Services

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Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, announced that it had completed an expansion project at its Kansas City, Missouri, facility to significantly increase controlled-temperature storage capabilities for its clinical supply business.

The expansion has added 70,000 cubic feet of storage (2-8 degrees Celsius) at the site, representing a five-fold increase in controlled-temperature capacity. This is made up of a combination of both pallet and high density storage options to increase flexibility. In order to support growing customer demand, two secondary cold packaging areas have been added, with the option to add more as needed.

“Customers have benefitted from our Kansas City campus’ integrated analytical, oral solid manufacturing, and clinical supply services, and now we can offer them expanded cold storage and packaging services as well,” commented Tom Moon, General Manager of Clinical Supply Services at the site. “In the past 18 months, we seen an increase in the numbers of both large and small customers, and to meet this growing demand have nearly doubled our clinical supply workforce, as well as introducing additional shifts in both packaging and distribution.”

Catalent’s 450,000 square feet Kansas City facility provides a range of fully integrated support services, from development and analytical support through to packaging and distribution. In 2015, the site completed an investment project that expanded its high-potent and cytotoxic clinical drug packaging capabilities.

Catalent has also recently announced investment and expansions to its workforce in its clinical supply network at Bolton and Bathgate in the U.K., and in Singapore.

Sanner passes 60 million Euro mark in 2016

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“Once again, 2016 was a very successful year for Sanner. Compared to the previous year, we were able to increase our total turnover by 6.9 percent,” says Dirk Mähr, Managing Director of Sanner GmbH. “This continuous growth, as well as the numerous developments and investments show that we are well prepared for the future”, says Ralf Tiemann, Managing Director Sanner Kunshan China.

Investments included an exchange of most machines for Sanner products in Bensheim, Germany. “The increase in automation and the acquisition of new production machines contribute to an increase in capacity and efficiency,” says Mähr. In the coming years, Sanner will consistently expand its portfolio for capsules and desiccant packaging.

 

The company has also strengthened the range of services and developments of customer-specific products with the Sanner Atmo Guard System® and the IDP-Process®, which was recently introduced at Pharmapack Europe. The IDP-Process® meets the growing need for customized, holistic packaging concepts for pharmaceuticals and medical devices. Customers receive individual packaging solutions with a design that not only meets the highest requirements, but which is also suited for large-scale serial production, while fulfilling all technical and regulatory demands.

The expansion of the cleanroom capacities in Kunshan, China, focused on efficiency and product safety. Since February 2017, 200 additional square meters of production space are available at the site. However, Sanner does not rest on its laurels: “The past years’ successful business results and our excellent future prospects in Asia will require continuous capacity expansions over the coming years,” says Ralf Tiemann. Upon completion of the second construction phase at the end of the first half-year, the company will be able to produce in 2,700 square meters of cleanroom space.

A great deal has also happened at the production site in Hungary: on one hand, new employees could be recruited to strengthen the team. On the other hand, the sites in Bensheim and Budapest are cooperating more closely to establish a broader platform for future growth projects in Europe. “With these numerous portfolio and capacity expansions, we are sustainably investing in the future of our production sites”, Dirk Mähr summarizes. “This way, Sanner is well positioned for further growth.”