Gerresheimer will launch an innovative syringe safety solution through exclusive licence from West

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Gerresheimer will complete its product portfolio of prefillable syringes made of glass and plastics with an innovative, integrated, passive syringe safety solution, acquired through an exclusive licence from West Pharmaceutical Services, Inc.

“As a result of our long-standing partnership with the leading manufac-turer of packaging components and delivery devices for parenteral drugs we are pleased to have acquired the rights to market this innovative, new syringe safety solution, developed by West. By doing so, we will complement our very broad range of prefillable syringe solutions for biotech and other drugs,” said Uwe Röhrhoff, CEO of Gerresheimer AG.

Gerresheimer is a leading supplier of prefillable syringes made of glass and plastics with a broad product portfolio. The new safety solution is fully compatible with Gerresheimer’s well-established RTF (ready-to-fill) syringe portfolio. The solution is fully integrated and will be assembled on the syringe in the run of the RTF production process. It is compliant with standard nests and tubs, which enables the pharmaceutical company to use the standard filling process.

The high amount of needlestick-related injuries among healthcare workers has led to increasing demand for innovative safety solutions. International regulation has paved the way for more safety for healthcare workers and patients. The new Gerresheimer integrated safety syringe will address this market need by offering improved syringe processability and high-end user friendliness.

West will maintain its current safety solution portfolio of products, which are already commercially available. For more information, please visit www.westpharma.com
More information about Gerresheimer RTF syringes: www.gerresheimer.com/en/products/pharmaceutical-primary-packag-ing/syringes-made-of-glass

Aptar Pharma Extends its Child-Resistant Nasal Pump Manufacturing Capabilities in North America

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Aptar Pharma, the leading manufacturer of drug delivery systems for nasal applications worldwide, announces the installation of manufacturing capacity for its Child-Resistant and Senior-Friendly Classic Nasal Pump in their Congers, NY site.

Effective April 2017, a new assembly machine for Aptar Pharma’s Child-Resistant (CR) feature for nasal sprays was transferred from Aptar Pharma’s plant in Southern Germany to Congers, NY. This represents an important step in Aptar Pharma’s history, bringing its manufacturing capacity closer to the target market for which this pump has been successfully established.

Aptar Pharma’s Child-Resistant technology platform was developed primarily for the U.S. market when, in 2012, the U.S. Consumer Product Safety Commission (CPSC) issued a rule requiring Child-Resistant packaging for any over-the-counter or drug product containing the equivalent of 0.08 milligrams or more of imidazoline (16 CFR Part 1700.14), a formulation widely used in nasal decongestant topical sprays.

Less than two years after the rule’s announcement, Aptar Pharma introduced its newly-engineered Child-Resistant/Senior-Friendly nasal spray pump to the U.S. market, which successfully matched the CPSC requirements. This feat once more underscored Aptar Pharma’s worldwide reputation as an innovative leader and trusted partner in the pharmaceutical industry.

Aptar Pharma’s Child-Resistant Feature for nasal sprays effectively combines Child-Resistance (CR) and Senior-Friendliness (SF) with its intuitive and widely-accepted squeeze-and-turn technology. The positive market feedback and increasing demand for the Child-Resistant Feature over the last two years demonstrates that Aptar Pharma’s CRSF technology is the best-in-class solution available on the U.S. market. As of today, all major brands of nasal decongestant topical sprays in the U.S. come with Aptar Pharma’s Child-Resistant Feature.

According to Alex Theodorakis, President Aptar Pharma North America, “We are pleased to welcome the arrival of Aptar Pharma’s Child-Resistant assembly machine to our recently-expanded Congers, NY manufacturing site. This added manufacturing capacity enables us to offer the production of this key Child-Resistant/ Senior-Friendly feature to our customers domestically. Being closer to our customers continues to be of strategic importance to Aptar Pharma, and this new initiative enables us to continue to support our important North American marketplace and increase our demand reactivity.”
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Aptar Pharma Congers site, NY – Courtesy of Aptar Pharma

Nemera announces a research agreement with UFRT (University of Tours) on new nasal drug delivery treatments

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Nemera and the Research Center for Respiratory Diseases (CEPR) of Tours University (INSERM U1100) join forces in a partnership to enhance drug therapeutic effectiveness in the nasal cavity.

The number of applications through the nasal route is expanding. The development of systemic medicinal products through the nasal mucosa is increasing, as well as new treatments directly targeting the central nervous system (nasal administration allows avoiding the blood-brain barrier). The nasal route of administration is easily accessible; it allows a focused efficacy and an outstanding usability, making patients’ lives easier than other types of treatments.

The purpose of this partnership is to develop a new method of nasal administration.

This collaboration relies on the expertises of Tours University in respiratory pre-clinical and clinical research, as well and Nemera’s experiences in development of drug delivery devices.

Sanner GmbH has acquired Jaco S.A., based in Kirchheim, France. Through the merger Sanner now advances to the global market leader for effervescent packaging.

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Sanner is known as market leader for desiccant packaging in the global pharmaceutical and healthcare sector. The company Jaco S.A. is one of the leading manufacturers of printed and unprinted plastic tubes for effervescent tablets. “Our product portfolios complement each other ideally,” says Dirk Mähr, Managing Director of Sanner GmbH. “As a result of the merger, we have significantly strengthened our market position and have become the world market leader for effervescent packaging.” In 2016, Sanner generated annual sales of 63.7 million Euros, while Jaco S.A. achieved around 13 million Euros.

“Together, we offer our customers one of the most comprehensive ranges of tubes and closures, combined with numerous decoration possibilities. This allows us to operate as a system supplier in the future,” says Tharcisse Decker, Managing Director of Jaco S.A. “Apart from the strong French and European market, we are now also able to enter new markets such as the Middle East or Africa more effectively,” Dirk Mähr adds. Moreover, Jaco S.A.’s experience in printing technology can be used for new products, while Sanner’s competencies in research and development are of great advantage for joint, innovative projects.

The acquisition will have no effect on the employees or the production of both companies. Customers will be served by the sites in Bensheim and Kirchheim. The company name Jaco S.A. will remain unchanged for the time being. The former owners of Jaco S.A have withdrawn from business. The parties agreed on keeping the purchase price confidential.

New ISO 7 injection-blow moulding line at Union Plastic: UP PHARM® bottle

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For the last 60 years, Union Plastic has been renowned for its expertise in the field of plastic injection moulding particularly targeting the healthcare sector and, at the present time, offers the healthcare industries high-quality plastic products, ranging from dosing systems, to medical devices and including consumables for in vitro diagnostics. The company has just been equipped with a new injection-blow moulding line in an ISO 7 class environment for the manufacturing of a new bottle: UP PHARM®.

Union Plastic has made innovation a central priority for the last 2 years and, as such, has added a new area of expertise to its arsenal, injection-blow moulding. With this expertise, the company is now in a position to develop LDPE, HDPE and PE plastic bottles of volumes varying from 5 to 100 ml.

The first part of this electric machine is a pre-injection plastic processing section. The second consists of a triangular turret where, simultaneously, a first mould injects plastic to form preforms while another mould blows previously manufactured preforms unidirectionally so as to give them a hollow shape. Finally, at the same time, on the last side of the triangle, the hollow bottles manufactured using the first two moulds are ejected. These two moulds are characterised by their horizontal closure, unlike plastic injection moulds which are closed vertically.

Union Plastic now offers the supply of bottles blow-moulded with controlled processes, entirely in an ISO 7 class environment as per NF EN ISO 14644-1:2016. Blower ceilings equipped with high efficiency filters protect the zone where parts are injected. The parts are subsequently conveyed into an ISO 7 room for assembly and packaging.
This ISO 7 class environmental conditions are equivalent to Good Pharmaceutical Manufacturing Practices Class C. This particulate cleanliness is a real advantage for the healthcare sector since ISO 7 class bottle production makes it possible to reduce residual endogenous endotoxins after sterilisation.

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This distinctive offering can now compete with the rare panel of bottle suppliers who offers such an ISO 7 class quality level.

With this advantage, Union Plastic is targeting the ophthalmic and self-medication market, particularly bottles intended for the nose, mouth and ears containing active ingredients sensitive to ambient bacteria such as antiseptics or antibiotics.
A range of catalogue products is under development and will expand the offering of blow-moulded bottles
for the healthcare sector.

Almac Group Announces Publication of Prostate Cancer Metastatic Assay Validation

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Almac Group’s Diagnostics business unit has announced the Journal of European Urology has published results relating to its Prostate Cancer Metastatic Assay. The publication demonstrates the assay can be used to analyse primary prostate cancer FFPE samples to identify a molecular subgroup with a high risk of developing distant metastases. The assay therefore has the potential to guide the choice of therapy for patients presenting with primary prostate cancer.

Professor Richard Kennedy, MD, PhD, VP and Medical Director, Almac Diagnostics and McClay Professor in Medical Oncology, Queen’s University Belfast commented “An unbiased discovery approach was used to identify a molecular subtype of primary prostate cancer that demonstrated metastatic biology. This approach has created a very robust assay with excellent performance, independent of clinical factors such as Gleason and CAPRA. We believe it will play a significant role in aiding clinicians to select the most appropriate therapy regimen for their patients.”

The study was conducted in conjunction with The Movember / Prostate Cancer UK funded Prostate Cancer Centre of Excellence at Queen’s University of Belfast and Manchester University along with Cardiff University, University College Dublin, Oslo University and the University of Surrey. Independent assay validation was performed using 322 radical prostatectomy samples with Metastatic Assay positive patients having increased risk of biochemical recurrence (Multivariable HR 1.62; p= 0.0092) and metastatic recurrence (Multivariable HR=3.20; p=0.0001). A combined model with CAPRA-S identified patients at increased risk of biochemical and metastatic recurrence superior to either model alone (HR=2.67; p<0.0001 and HR=7.53; p<0.0001) respectively. “The publication of this manuscript in a journal of this calibre represents a significant milestone in the assay’s development and with two additional manuscripts being prepared for submission, further milestones are expected to be reached later this year. The first is another clinical validation but this time using biopsy FFPE tissue and the second is analytical validation to demonstrate the assay can be transferred to several commercial platforms.” said Professor Paul Harkin, President and Managing Director, Almac Diagnostics. He went on to say “Almac has been at the forefront of RNA based genomic innovation for over 10 years and this assay represents just one of our innovative pipeline of predictive and prognostic tests”.

Metsä Board Launches Its Unified Offering of Products and Services

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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.