Tekni-Plex granted patent for first-of-its-kind Sniff Seal technology

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Tekni-Plex has been granted a patent for its Sniff Seal® technology which is the first liner to enable scent permeation through an induction seal closure liner without affecting the seal or compromising the contents.

Brand owners are constantly looking for ways to create product differentiation. Consumers are also interested in enhancing their purchasing experience. Sniff Seal technology is an ideal way for the consumer to experience a scent in the retail aisle without compromising the seal or the product contents. A wide variety of product categories, including food, beverage, personal care, cosmetics can benefit from the technology.

“There are many instances where consumers want to know what a product actually smells like before putting it in the shopping cart. Unfortunately, there are times when consumers peel back seals or remove fitments to experience the scent before buying. When a package is returned to the shelf in a compromised condition, it is no longer sellable. As a result, the retail industry experiences a significant amount of loss annually,” explains David Andrulonis, senior vice president and general manager, Tri-Seal, a Tekni-Plex business unit.

Sniff Seal liner technology eliminates the problem because it provides the olfactory experience without removing the seal. This means that the tamper and/or pilfer evidence remains in place and the product integrity is maintained.

An extensive range of products can benefit from this technology. Imagine being able to experience the smell of fresh peanut butter or mango-scented shampoo or spring-fresh deodorant in a retail aisle without removing a seal or a fitment? That’s what Sniff Seal brings to the purchasing experience,” Andrulonis said.

Fareva opens its new analytical building dedicated to high potent technology

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Fareva has just opened its new analytical building dedicated to high potent technology on its site of Excella, Germany, welcoming 88 working spaces. This 7 m€ investment targets to support new chemical entities registration, quality by design studies, with the ability to handle molecules with an OEL < 1 µg/m³.

It will be completed in Q2 2019 with the addition of a Gerteis roller compactor that allows to manufacture up to 30 kg batches from clinical to commercial phases for 2,5 m€. It has been designed to be certified for Europe, Japan, Korea, USA and other markets.

Fareva APIs is also competing a major investment of 25 m€ on its French site of La vallee, to manufacture OEB4 APIs. First production is expected in August 2018.

Almac Group Recognised with CMO Leadership Awards

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Almac Group, the global contract pharmaceutical development and manufacturing organisation, has announced it has been awarded CMO Leadership Awards for the sixth consecutive year.

The CMO Leadership Awards recognises top outsourcing partners, determined by feedback from sponsor companies who outsource manufacturing. Each year, the awards are presented by Life Science Leader and Industry Standard Research (ISR) during an annual award ceremony which celebrates drug development and manufacturing.

Almac Pharma Services received three awards at the prestigious celebratory event held on 21 March in New York which recognised its capabilities, overall compatibility and outstanding quality at small pharma level.

The global organisation recently announced the completion of a £20 million investment in its cold chain management capabilities with the opening of a 95,000sq ft custom built cold store facility at its global headquarters in Northern Ireland. The new facility complements Almac’s existing global drug product capabilities by boasting over 3,000 pallet spaces including -15°C to -25°C storage capacity, additional 2°C – 8°C secondary production rooms, 3PL processing areas and a custom designed clinical labelling suite.

Adam Schroeder, Director Business Development, Almac Pharma Services commented “Once again, we are delighted to receive these awards which recognises continued investment in our global capabilities and solutions. This achievement strengthens our commitment to better serve our clients, and ultimately patients worldwide, thereby maintaining our position as a global leader in the life sciences sector.

Duma Standard container now available with child-resistant Duma Handy cap made out of one component

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Gerresheimer presented its Duma Standard CR (child-resistant) container with Handy Cap CR at Pharmapack last month in Paris. This is the company’s first snap-on cap with child-resistant (CR) solution. The snap-on cap is a one-component-system compared to more conventional child-resistant screw-cap solutions that are made of two components.

“I’m a father myself and I know how curious children are,” says Niels Düring, Global Executive Vice President Plastic Packaging. “You have to be very careful because they’ll play with anything they can get their little hands on. So it’s vital for drugs to be supplied in childproof packaging.”

Only the 40 ml version of the new Duma Standard CR container is cur-rently available with the Handy Cap CR. Other sizes can be supplied upon request.

Children experiment with everything and that includes medicines – mummy’s tablets could well be some sort of tasty treat, after all. This means tablets should be stored out of the reach of children. This is much easier said than done, however. It is all too easy to leave a box of tablets behind on the kitchen table where your child can play with it.

Packaging like the new Duma Standard CR container with its child-resistant cap is designed to prevent young children from getting hold of items like medicines that could be harmful to their health. Many products that could pose a threat to young children’s health are required to incor-porate a safety device under national and international law. ISO standard 8317 (2015) applies in Europe and US 16 CFR section 1700.20 in the U.S.

ISO 8317 (2015)

ISO 8317 (2015) is the international standard for reclosable child-resistant packaging. It governs both pharmaceutical and technical chem-ical products.

The standard describes two test procedures, which any packaging to be tested must be subject to. One test is run with a group of up to 200 youngchildren aged between 42 and 51 months. They must not be able to open the packaging, which is filled with a harmless replacement substance. At the same time, a test group of older people aged between 50 and 70 must
be able to open and reclose it without imparing the child-resistant func-tion. Packaging will only meet the requirements of ISO 8317 (2015) if the tests demonstrate that they are safe for children and user-friendly for the elderly, as defined in the standard.

The test

During the test, children have an initial five minutes to try opening the packaging. Afterwards, they are shown how to open it once without any explanation. They then have another five minutes to try opening it.

The packaging is deemed child-resistant if no more than 15 percent of children are able to open it within the first five minutes. A maximum of 20 percent of children are permitted to succeed in getting at the contents of the packaging for the entire duration of the test.

If only a few young children manage to open the packaging, the test group could be reduced to fewer than 200 children as part of the sequen-tial evaluation process.

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Tests with older people aged between 50 and 70

During the test, the participants have an initial five minutes to try opening the packaging. They are not shown how to do so besides the instruction on the packaging. In the second phase, they only have one minute to try and open it. The packaging is deemed suitable for older people as long as at least 90 percent of the test group are able to open and reclose it again without imparing the child-resistant function within a reasonable amount of time.

The test group is designed to include 100 people, of whom 25 are aged between 50 and 54, 25 between 55 and 59, and 50 between 60 and 70. 70 percent of each of these age groups should be female.

The US 16 CFR section 1700.20 regulation also stipulates the requirements child-resistant packaging must meet. These are similar to the standards applicable in Europe but are even more extensive for medicines.

 

 

Novartis teams up with Harvard to develop next generation biomaterial systems to deliver immunotherapies

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Novartis has announced that it is teaming up with scientists from the Wyss Institute for Biologically Inspired Engineering at Harvard University and the Dana-Farber Cancer Institute to develop biomaterial systems for its portfolio of immuno-oncology therapies.

The licensed biomaterial systems aim to overcome barriers that have hampered traditional cancer vaccines, including their limited duration of action and lack of targeting to specific cancer cells. Through many years’ work, researchers at the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS), the Wyss Institute, and Dana-Farber have engineered the biomaterial systems with an aim to provide sustained delivery of immunotherapies and target specific types of cancer. Novartis will further collaborate with the team at the Wyss Institute to advance development of the biomaterial systems, investigating their use to deliver agents from its broad and deep portfolio of second-generation immunotherapies.

“Our collaborators have combined the fields of immuno-oncology and material science to develop novel platforms for delivering immunotherapies to combat cancer,” said Jay Bradner, President of the Novartis Institutes for BioMedical Research (NIBR). “We look forward to collaborating with the Wyss Institute to further develop this technology in conjunction with our growing immunotherapy portfolio.”

The licensing agreement with Harvard’s Office of Technology Development and the collaboration with the Wyss Institute support Novartis’ efforts to develop combination immunotherapy regimens. New immunotherapies have benefited subsets of cancer patients, presenting opportunities to develop new immuno-oncology treatment strategies to help more patients [1]. Novartis is developing combination immunotherapies in clinical trials.

The implantable and injectable systems are made of biodegradable materials that assemble into porous, three-dimensional structures. In lab experiments, the systems release cell-recruiting factors to attract host dendritic cells and present tumor antigens to those specialized immune cells, intending to bolster immune responses to cancer [2]. While these systems have yet not been proven in human clinical trials, they hold great promise because of their potential to serve as engineered microenvironments to educate the immune system about cancer and initiate immune responses against tumors over a sustained period of time.

The technologies licensed under this agreement for target-specific applications are owned or co-owned by Harvard University, Dana-Farber, and the University of Michigan.

Therapeutic application of mAbs will increase in near future, says GlobalData

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Ever since the first commercial monoclonal antibodies (mAbs) was approved in 1986 for human therapeutic purposes, mAbs have been increasingly used in several areas of healthcare. According to GlobalData, a leading data and analytics company, the total number of clinical trials involving mAbs witnessed a robust 115% growth between 2007 and 2016.

The company’s Clinical Trials Database provides a review of company-sponsored, interventional, observational, and expanded-access clinical trials of Monoclonal Antibodies (mAbs) across the globe for the past 10 years from 2007 to 2016.

Marco Borria, PhD, senior clinical trials analyst at GlobalData said, “Even though phase II trials outnumbered all other trials, phase I studies have grown faster than all other phases during the review period.”

During the review period, 57% of trials were completed, out of which 76% reported results. Among these, 79% achieved their primary endpoints.

Out of all the trials initiated, Roche has emerged as the lead sponsor, with the company’s bevacizumab as the most investigated drug. The other top industry sponsors were Novartis, Eli Lilly, Amgen, AbbVie, Pfizer, Bristol-Myers Squibb, Genentech, J&J, and GSK.

Oncology was the top therapy area in terms of number of clinical trials, followed by immunology, central nervous system, musculoskeletal disorders, and gastrointestinal. The most common indication under investigation in these trials was rheumatoid arthritis, followed by solid tumors and non-small cell lung cancer.

There is a near-even split between multinational and single-country trials across the period. However, in the last three years multinational trials outnumbered the trials conducted in a single country.

In terms of clinical trials by geographies, Europe accounted for almost 50% trials, followed by North America, Asia-Pacific, South and Central America and the Middle East and Africa.

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“As phase I studies have proliferated more than other phases, the number of new interventions appear to be on the rise across a wider range of therapy areas and indications”, concluded Dr. Borria.