Clariant Expanding Capacity for Printing Tubes and Stoppers by 30%


Clariant, a world leader in specialty chemicals, and its Healthcare Packaging unit, are announcing plans to install new, high-speed, six-color offset tube printing machines at Clariant’s production facility in Romorantin, France. The new equipment will increase capacity at the plant by an estimated 30 percent when the expansion is completed early in 2017.

The investment in additional printing capabilities is being undertaken to meet growing demand, especially by pharmaceutical and nutraceutical customers, and to offer global customers new options for customizing their package designs. Rigid tubes and accompanying desiccant closures are ideal for effervescent tablets, lozenges, and solid-dosage nutraceuticals.

The Romorantin plant, together with two other plants in Belen, NM, in the U.S.A., and Changshu, China, produces 40 different sizes of tubes and 50 different desiccant stoppers for global delivery. As demand for printed tubes is highest in Europe and North Africa, positioning its Center of Excellence for tube printing in France boosts Clariant’s ability to quickly serve this important market.

Installation of the new high-speed, offset tube printers has already begun, with some capacity increase expected by the end of October. Full-capacity should be available by Q2 2017. The speed of the new printing machines will complement the high-volume tube and stopper production capabilities already in place at the plant.

“Our large range of tube and desiccant stopper offerings gives customers flexibility and choice in their package design,” says Philippe Depois, Head of Sales, Clariant Healthcare Packaging. “And, we continue to expand tube and stopper production and state-of-the-art printing capabilities in Romorantin.”

Depois says Clariant is also highly experienced at custom package design, which allows global customers to more easily and rapidly customize their packaging to address market needs, while expediting product time-to-market.

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Unither Pharmaceuticals opens a Chinese subsidiary in Wuhan


Unither Pharmaceutical Technologies (Wuhan) Co LTD main aim is to bring innovative technologies to Chinese pharmaceutical laboratories and patients. According to IMS Health the amelioration of access to healthcare implemented by the Chinese government should increase the drugs expenses and reach €170 billion in 2018.

Unither Pharmaceutical Technologies (Wuhan) Co LTD is located in Wuhan Optic Valley Biolake, this 30 Km2 park created in 2008 is mainly dedicated to health industries (biology, pharmaceutics et medical devices). Bio-Park is aiming to create a new city integrating R&D, incubation, manufacture, logistics and living. The Innovation science park now has gathered more than 700 enterprises and work sites such as Pfizer, Menarini, Bayer and Fresenius Kabi.

Our mission consists of creating local partnerships in order to help our customers from United States, Brazil and Europe entering the Chinese market.

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Metsä: The need for anti-counterfeiting


Attractiveness is only one of a number of attributes that healthcare packaging must fulfill. “This is a demanding area,” Christophe Baudry points out. “Pharmaceutical packages must be reliable, promote the brand in question, preserve their quality on the shelf and in handling, be easy to use and maintain safe consumption.”

The need for anti-counterfeiting has become a major talking point in the industry. According to Interpol, the increasing prevalence of counterfeit and illicit goods has been compounded by the rise in Internet trade, where they can be bought easily, cheaply and without any prescription.
The dangers associated with counterfeit drugs are very troubling indeed. Interpol states that over one million people die each year from their consumption, and they represent one of the fastest-growing and most lucrative income sources for global organized crime networks.

“It has become hugely important for manufacturers of pharmaceuticals to find new ways to ensure public safety,” says Christophe Baudry. “Packaging can play a large and helpful part here. With the right tools we can help the consumer to identify whether the product inside is real or is fake.”

Depending on the medicine it houses, good packaging not only catches the eye, but can also help us to distinguish the real deal.

Metsä Board’s paperboards used for healthcare packaging deliver specific benefits for varied end uses. This allows all the professionals involved to focus on what matters most: keeping people healthy.

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AdPack® – High-level product and moisture protection


The AdPack® product family from Sanner consists of drop-in low profile desiccant packs for the protection of moisture-sensitive drugs. AdPack® is highly permeable and ensures long-term adsorption of moisture. The flexible non-dusting, lint-free Tyvek® material provides an excellent combination of barrier protection, durability and breathability. AdPack® takes up little space within a package. Moreover, the distinct shape of the packs eliminates potential confusion with capsules or tablets, and prevents accidental ingestion.

AdPack® is made with a lap seal which is flat without any layers sticking out. This ensures very good handling with existing filling lines. Many other desiccant packs are manufactured with fin seal – this overlapping seam risks to get stuck in the line during filling. Moreover, dust might get stuck underneath the seal.

To maximize flexibility for customers, AdPack® is compatible with standard semi- and fully-automated dispensing equipment and filling lines. AdPack® is available as single pack or on reel. AdPack® on reel ensures a clean pack separation through a punch hole in the seal between the packs. Filling trials showed a more reliable pack separation compared with eye-mark cut signs, which results in a cleaner cutting during the filling process.

Designed for pharma applications worldwide, AdPack® complies with all relevant European and FDA (Food and Drug Administration) regulations for contact with food and drugs. The products are also listed in a Type III Drug Master File (DMF). AdPack® can be seen live at CPhI India (21-23 November 2016, booth V97).

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Gerresheimer adapts its eye drop bottle to new FDA requirements


Gerresheimer is one of the world’s leading suppliers of plastic eye drop bottles. It recently modified the closure system on its Type A dropper bottle to the FDA’s new requirements. Now the tamper evident ring stays firmly affixed to bottle once it has been opened.

The tamper evident ring is important because it tells the user that the product hasn’t been opened since filling. This guarantees that the bottle contains the original pharmaceutical and that nobody else has previously opened or used it. Although that’s important with all medications, it’s particularly important with eye drops, which shouldn’t be administered if they are contaminated. “Sometimes it’s the little ideas that make a big improvement to a product,” said Marek Misczcak, Head of Research & Development at Gerresheimer and primary packaging expert for ophthalmic applications. “Before the modification, the tamper evident rings were loose on the bottle neck after opening. Unless the user removed the ring, it constituted a potential hazard. That’s why fixing the tamper evident ring in place is a good idea that improves safety.” None of the other eye drop bottle specifications have changed.

Cross section of the eye drop bottle with fixed TE ring

More information about the Gerresheimer eye drop bottle System A

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Sanofi & Verily Life Sciences, unit of Google, are launching Onduo, a diabete management platform

sanofi & google

Sanofi and Verily Life Sciences LLC, (formerly Google Life Sciences), an Alphabet company, today announced the launch of Onduo, a joint venture created through Sanofi and Verily’s diabetes-focused collaboration. The joint venture is based in Kendall Square in Cambridge. Onduo’s mission is to help people with diabetes live full, healthy lives by developing comprehensive solutions that combine devices, software, medicine, and professional care to enable simple and intelligent disease management.

Under the leadership of Onduo’s newly appointed Chief Executive Officer, Joshua Riff, M.D., M.B.A., the company will leverage Verily’s experience in miniaturized electronics, analytics, and consumer software development, and Sanofi’s clinical expertise and experience in bringing innovative treatments to people living with diabetes. Dr. Riff joins Onduo from Optum, the health services company of UnitedHealth Group, where he was senior vice president of prevention and wellbeing.

My experience as a physician and in leading consumer health initiatives has shown me the daily burden of living with diabetes,” said Dr. Riff, CEO, Onduo. “From monitoring food intake to testing glucose levels to actively seeking medical care, the challenges both on the physical and mental well-being of a person living with diabetes are incredibly difficult. We want to develop solutions that allow people living with diabetes to focus on the things they love and enjoy in life by providing tools to make dealing with their diabetes less burdensome.
Initially, Onduo will focus on the type 2 diabetes community, specifically on developing solutions that could help people make better decisions about their day to day health, ranging from improved medication management to improved habits and goals. Over time, the company plans to expand its focus to include the type 1 diabetes community, and eventually to people at risk of developing diabetes with the goal of helping them better prevent the onset of the disease.

The integration of multiple interventions, such as data-driven patient support and devices in addition to treatment, can help improve outcomes, which is important from the perspective of patients, healthcare professionals and the overall healthcare system,” said Peter Guenter, Executive Vice President, Head, Global Diabetes & Cardiovascular Business Unit, Sanofi. “The new company Sanofi and Verily invested in will adopt a more service-centric approach and support doctors in their efforts to treat their patients more effectively. In addition to developing innovative therapies for diabetes which will remain a key focus for Sanofi, we see these solutions which combine innovative therapies and services as the future for diabetes care. We believe this will help societies cope with the burden of this epidemic.

Joining Forces with Experts and Advocates
Onduo is taking a multi-stakeholder approach to diabetes management by involving the diabetes community, clinicians, payers and healthcare professionals in the product development process. Sutter Health of Northern California and Allegheny Health Network of western Pennsylvania are among the first healthcare networks to collaborate with Verily and Onduo to test the Onduo platform with healthcare professionals and people with type 2 diabetes in a clinical care setting. Sutter Health’s not-for-profit network of physicians, hospitals, outpatient surgery and specialty centers and other healthcare services, including home health and hospice, medical research and education/training, cares for more than 3 million patients. . Allegheny Health Network is an academic healthcare system consisting of eight hospitals, outpatient surgery centers, health and wellness pavilions, a research institute and more than 1,100 employed physicians. Premier Medical Associates, part of Allegheny Health Network, is the largest multi-specialty physician practice in the Greater Pittsburgh area.

This is an innovative collaboration that spans the healthcare continuum and benefits from deep and cross-functional expertise, giving us unique potential to create tools and solutions that could have a positive clinical effect,” said Jessica Mega, M.D., M.P.H., chief medical officer of Verily. “Our goal is to connect the dots for health care providers on the ‘moments of truth’ that happen outside of the clinical setting, and to help people manage diabetes on a daily basis. Our collaborations with health networks like Sutter Health and Allegheny Health will help bring that vision to life.

Additionally, Onduo is discussing with patient advocacy groups like Taking Control of Your Diabetes (TCOYD) to provide input on future product designs.

With Onduo, Sanofi and Verily are bringing forward a platform that is novel and critical in diabetes management,” said, Steven V. Edelman, M.D., Founder and Director, TCOYD. “Onduo is a company focused on the improvement of health outcomes through the marriage of technology and medicine. Its information-based solutions align well with TCOYD’s mission to empower people with diabetes and their loved ones to effectively and easily take control of diabetes. We welcome and support Onduo’s efforts and look forward to their progress.”

Joshua Riff, M.D., M.B.A. Named CEO
Dr. Riff is an emergency medicine physician by training. He was most recently the senior vice president of prevention and well-being at Optum, the service arm of United Healthcare. Prior to that, Dr. Riff served as medical director at Target, where he ran the health plan for Target team members and provided medical oversight to their clinics and pharmacies. He completed his M.D. and M.B.A. at Tufts University in conjunction with Brandeis University in Boston, Mass. After medical school he completed his residency in Emergency Medicine at Johns Hopkins Hospital.

About Diabetes
Diabetes is a chronic disease characterized by elevated blood sugar due to inefficient or deficient insulin production. In 2014 it was estimated that globally, 422 million people suffer from the disease.1 Diabetes can be classified in two major subsets, type 1 and type 2. Type 1 diabetes is an autoimmune disease that occurs when the pancreas stops making insulin and therefore must be regulated via daily administration of insulin. Type 2 diabetes is a metabolic disorder in which a person’s body produces insulin, but is not able to regulate it efficiently. Over time, the disease can result in serious or life threatening complications, including damage to the heart, eyes, kidneys and nerves.2 Research suggests that the recommended self-care regimen for people with type 2 diabetes on oral medications requires at least two hours daily.3 It has been estimated that the global economic burden of diabetes is U.S. $827 billion.


What’s next for CMOs?

CMOs are finding ways to survive and thrive in a rapidly changing landscape

Why is the CMO industry in such flux, and why does the rate of change seem to be accelerating?

There are a great many factors, but the most prominent is cost. Pharmaceutical companies worldwide are under enormous pressure to contain costs, and in response have reduced their internal manufacturing, R&D and marketing functions. New efficiencies in communications, development, production, and distribution have allowed smaller, more nimble CMOs to step into the areas that larger companies are now outsourcing.

For years, CMOs quietly went about their business, delivering APIs and excipients, providing supplies for clinical trials and augmenting in-house capabilities to meet demand as production was ramped up to meet launch demands or increasing sales. They flew under the radar, quietly servicing their more vertically-integrated customers.

And then it all changed. Introductions of blockbuster drugs, which had driven so much of the growth of Big Pharma, slowed to a virtual halt. Important new drugs were—and are—being brought to market constantly, but compared to the products introduced during the 1990s and 2000s, don’t offer the potential sales volume of their category-creating predecessors.

The great fragmentation is underway

In an effort to cut costs, many pharmaceutical companies have returned to their core competencies such as R&D and marketing, while outsourcing many other resource-intensive functions. While this has led to leaner, more focused organizations, it has also created a new set of realities: CMOs now have to be brought into the product development process far earlier than previously, working protocols have to be established to insure efficient use of resources and personnel, and communications systems have to be enhanced to assure clear communications throughout the development process, especially at critical touch points and handoffs. CMOs have adapted to this new reality and ramped up equipment and services to meet the demand. Many have merged with other companies to bring greater capabilities and cost-savings in-house, or to provide profitable niche services, such as small production runs for clinical trials.

At the same time, biopharmaceuticals and biosimilars, with their challenging development, manufacturing and distribution profiles, have continued to experience tremendous growth. Sales of biologics now top $200 billion, while sales of biosimilars have increased to $20 billion, a figure that is expected to more than double by 2020. The increasing applicability of large-molecule agents to a variety of disease states and conditions has further served to boost demand and stretch capacities. CMOs are meeting these challenges with technologies that address key issues such as targeted delivery, abuse-deterrent formulations, and new administration modalities.

As the trend toward outsourcing has continued, pharmaceutical companies have come to expect greater and greater involvement and capabilities from their CMOs. CMOs have had to look beyond their traditional roles and to consider expanding into areas that just a few years ago would have been considered beyond their core competencies. If the past is any indication, the wider the range of capabilities and the more expertise the CMOs can bring to the table, the more likely it is that large pharmaceutical manufacturers will have the confidence to establish long-term strategic relationships with them.

This is not to say that smaller biopharmaceutical companies have been sidelined. They have been playing important roles in the research and development of new drugs and have helped to keep open the pipeline of new products under development. Many have developed unique niche capabilities that their clients value but can’t perform economically in house and must therefore outsource.

Opportuities abound

The downsizing and consolidations of the larger pharmaceutical companies have created opportunities for forward-looking CMOs, which have been expanding into plants that the larger companies have vacated. The French CMO Fareva is expanding their existing plants in France and has been investing in new facilities in the United States and Latin America as well. With many of its plants in France reaching the saturation point, expansion has become increasingly necessary. “We are facing pressing demand for some forms and types of product that we produce at the plants concerned,” explains Bernard Fraisse, chairman of the family-owned business. The company, which has experienced rapid growth, largely from new acquisitions, is now “prioritizing organic growth,” according to Fraisse.

Like Fareva, other CMOs are taking advantage of consolidation to buy up facilities and equipment to meet the burgeoning demand. The trend shows no sign of abating thus far. For CMOs that can provide the service, capabilities and capacity that major manufacturers need, the future seems bright indeed.