Magnisense won two awards for the MIAG product: Health award “Janus 2018 “and “label 2019 Observer of the design”.

Plastibell

 

MIAG (Mobile Diagnostic), is the first connected mobile device enabling emergency diagnosis of cardiovascular diseases in less than 15 min, from just a few drops of blood, with results being sent to the hospital in real time. Plastibell contributed to the MIAG success and was involved from the design phase, industrialization and is now manufacturing the plastic part of the reagent.

Tekni-Plex acquires cleanroom film extruder, converter Beyers Plastics

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Tekni-Plex, Inc. has acquired Beyers Plastics, Puurs, Belgium, a cleanroom Class 7 extruder and converter of polyethylene (PE) film, from investment company FAMO N.V.

Beyers will now become part of Tekni-Plex’s Tekni-Films business unit. It specializes in producing PE packaging for pharmaceutical, medical and other industries such as food, aerospace, solar energy, semi-conductor and chemicals.

“The acquisition of Beyers Plastics allows us to expand our portfolio of cleanroom-produced pharmaceutical and medical flexible packaging products. For the first time, we will have bag converting capability, as well as PE blown film extrusion,” said Joe Horn, senior vice president and general manager, global, Tekni-Films. “The acquisition supports our goal of expanding our offerings in the pharmaceutical and healthcare space.”

“We look forward to becoming part of Tekni-Plex’s global healthcare packaging presence. Our combined expertise and manufacturing capability will provide packaging solutions for more companies, as well as grow sales for our combined product lines,” said Johan Noelmans, general manager, Beyers Plastics.

The Beyers Plastics purchase is the tenth acquisition Tekni-Plex has made in the past four years, supporting its strategy to grow its business though transformative acquisitions and strategic add ons. Tekni-Plex has a solid track record of successful business integrations, having acquired companies with innovative plastic and rubber products to further drive growth.

Almac Group Invests in Cutting Edge Next Generation Sequencing Capabilities for Bio Pharma Clients

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Almac Diagnostic Services, a global stratified medicine company specialising in biomarker driven clinical trials, has made a significant investment in a new Illumina NovaSeq 6000 sequencer which will benefit Biopharma clients’ biomarker discovery and clinical trial projects.

The addition of the NovaSeq’s powerful processing capabilities to Almac’s existing range of NGS platform offerings allows for larger sample runs, greater read depth and faster speeds. The new instrument will ultimately reduce sample turnaround times and increase variant detection quality and accuracy for clients.

With the NovaSeq, Almac will be able to sequence the transcriptomes of up to ~384 samples, per run (dual flow cell, 50M reads per sample) in a timeframe as short as 36 hours.  The NovaSeq provides scalable throughput and flexibility for virtually any sequencing method, genome, and scale of project.  To accommodate NovaSeq’s high capacity and efficiency, Almac has also invested in appropriate informatics infrastructure and installed high speed uplinks to cloud based providers.

The NovaSeq will form an integral part of Almac’s current DNA and RNA Sequencing offerings and future offerings for Whole Genome Sequencing (WGS) and Whole Exome Sequencing (WES).  Almac Diagnostic Services already has extensive expertise in Next Generation Sequencing (NGS) technology and Bioinformatics. The company offers a customisable solution that allows clients to tailor their diagnostic requirements across multiple platforms and chemistry options to suit their specific translational research or clinical trial needs.

Michael Sloan, Global VP of Commercial Operations, Almac Diagnostic Services said: “We are excited about the potential benefits the NovaSeq will be able to bring to our customers with its sequencing capabilities enhancing our current DNA and RNA NGS panel offerings to the market. We are positioning ourselves at the cutting edge of NGS diagnostics and the investment in this new NGS platform will help Almac to continue to play a leading role within stratified medicine.”

The NovaSeq will also support Almac Diagnostic Services new unique gene expression report, claraT, which will be launched to market at ESMO 2018 in Munich in October. claraT is a unique software-driven solution, classifying biologically relevant gene expression signatures into a comprehensive, easy-to-interpret report for cancer research / biomarker discovery.

Series production of Gx RTF ClearJect plastic syringes started

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Gerresheimer has commenced with series production of the new Gx RTF ClearJect syringes. The products of the high performance plastic COP (Cyclo Olefin Polymer) are used where especially sophisticated medications need to be packaged. The new Gx RTF ClearJect syringe 1 ml long with cannula is the first plastic syringe developed and produced by Gerresheimer itself.

Gerresheimer brought together its comprehensive competence in glass production at the Bünde location and the expertise of its plastic specialist in the Technical Competence Center (TCC) Wackersdorf for the development and industrialization of the new syringe. The production facility was thus planned and built by the automation team of the Technical Competence Center; the know-how for the quality control and quality guidelines for primary packaging originates from the inspection specialists of the glass location Bünde, and was adapted jointly to the specific requirements of plastic production. Production takes place pursuant to the especially high quality requirements for pharmaceutical primary packaging material corresponding to GMP. The new production facility is conceived in such a way that the entire processing chain from injection molding to finished RTF packaging is covered. A series of cameras were installed at various stations for quality control, with which all relevant geometrical parameters and cosmetic-visual defects are checked for each individual product.

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Innovative medications mean strict requirements for their primary packaging. Especially biotechnologically manufactured active agents may not interact with the packaging, because this could mean undesirable effects for patients. Gx RTF ClearJect syringes offer especially low interaction potential. The material COP has a high pH tolerance, does not emit metal ions into the medication solution, and therefore causes no displacement of the pH value while in storage. The syringe is manufactured as an injection molding part in an 8-fold hot runner mold. The cannula is also thereby injected at the same time and does not need to be retroactively glued in. Tungsten and glue residue is therefore eliminated with the Gx RTF ClearJect syringes. The precise geometry of the injection molding part reduces the dead volume in the syringe, leaving behind less of the expensive medication in the syringe. Also attractive is the increased safety for the end consumer. COP is particularly break-resistant, making it suitable for packaging aggressive or toxic materials.

The new Gerresheimer Gx RTF ClearJect COP syringe is available in the long 1 ml size with cannula. The design corresponds to ISO 11040-6. The first version of the syringe is equipped with a 27-gage, 1/2-inch (12.7 mm), and thin-walled stainless-steel needle with three bevels. The syringes are siliconized with a precisely controlled amount of high-viscosity, and thus low-particle Dow Corning 360 MD (12,500 cSt) silicone oil, offering a comprehensive syringe system that completes the COP syringe body with plunger rods, plunger stoppers, finger flange, and closure systems. An economically efficient complete solution is achieved through the use of commercially available standard components.

More information : Syringes made of plastics

Sun Pharma acquires Pola Pharma in Japan, to help in building global dermatology business

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Sun Pharmaceutical Industries Ltd. Has announced that Sun Pharma has entered into a definitive agreement to acquire Pola Pharma Inc. (“Pola Pharma”), a Japanese pharmaceutical company engaged in research and development, manufacture, sale and distribution of branded and generic products in Japan. The portfolio of Pola Pharma primarily comprises dermatology products.

Pola Pharma, part of POLA ORBIS Group, has two manufacturing facilities in Saitama with capabilities to manufacture topical products and injectables. It also has R&D capabilities to develop new technologies and formulations.

Kirti Ganorkar, Executive Vice President, Sun Pharma said, “This acquisition is in line with our strategy to strengthen our global dermatology presence. Pola Pharma is a leading dermatology company and it will help us to launch our speciality and generic dermatology products in the Japanese market in future.

We also get access to local manufacturing capability enabling us to serve the Japanese pharmaceutical market more effectively.” Junichi Nakamichi, Country Head of Japan, Sun Pharma said, “By combining Sun Pharma’s global strengths with Pola Pharma’s local expertise, we will have a great opportunity to further strengthen our presence in Japan, especially in the area of dermatology.”

Roche subsidiary Genentech acquires Jecure Therapeutics

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Jecure Therapeutics Inc., a biotechnology company with novel drug discovery programs targeting serious inflammatory diseases, today announced a definitive agreement by which it will be acquired by Genentech, a member of the Roche Group. With this acquisition, Genentech will obtain full rights to Jecure’s entire preclinical portfolio of NLRP3 inhibitors.

Genentech has an extensive history of translating pioneering science into transformative medicines,” said Jeffrey A. Stafford, Ph.D., president and CEO of Jecure. “The acquisition of Jecure provides a unique opportunity to bring novel NLRP3 inhibitors to patients.

“We’ve had a long-standing interest in targeting inflammatory pathways that may play a role in a number of serious diseases,” said James Sabry, M.D., Ph.D., global head of Pharma Partnering, Roche. “We’re excited to combine Jecure’s portfolio with our discovery and development capabilities, as well as our expertise in NLRP3 biology, to potentially help people with inflammatory diseases.”

Jecure began operations in 2015 with a seed financing from founding investor Versant Ventures. The company raised $20 million in a Series A round from Versant in 2017 to continue to develop and advance its portfolio of NLRP3 inhibitors.

SBC films are ideal alternative to traditional CFF and PCTFE for pharma products

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With pharmaceutical companies constantly looking for ways to improve their product packaging with performance-driven, cost-effective solutions, there is an alternative to traditional structures that is making its way into the main stream. Super barrier coated (SBC) films are now being considered for pharma and other healthcare applications.

Tekni-Films, a Tekni-Plex business, has introduced SBC 240 as a performance and improved-cost alternative for 4- and 6-mil PCTFE laminations and cold formed foil for blister applications. This thermoformable film has exceptional moisture and oxygen barrier properties and is designed to meet the needs of pharmaceutical and other healthcare applications. The triplex structure is ideal for applications such as pharmaceuticals, nutraceuticals, probiotics and other related products.

SBC is created by applying a next generation, high-barrier PVdC coating to a lamination of PVC and polyethylene. The PVdC is dispersed in an emulsion, which has been engineered as a surface coating. Multiple layers can be applied to create different coating weights. As coating weight thickness increases, the overall barrier properties also increase.

“For those pharmaceutical companies who may not be well-versed in the various attributes of SBC films, we have created performance data comparisons to CFF and PCTFE, including information on why the material lends itself to smaller pack sizes.  With material usage and environmental concerns at the forefront of every packaging decision, a smaller pack size is an important attribute to consider,” explained Melissa Green, senior director of global marketing for films.

Dual-Mix® Wins a Prize at the CPhI Pharma Awards 2018

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Technoflex® is proud to announce that their innovation, Dual-Mix®, has received the award for Excellence in Pharma in the Packaging category. It was chosen from among more than 250 candidates across 17 categories at the 2018 CPhI Pharma Awards. Dual-Mix® is a patented dual-chamber bag designed to hold a medicine in powder/lyophilizate form and its associated diluent. It enables the packaging of unstable molecules which need to be reconstituted just before administration to the patient. “Dual-Mix® is a major breakthrough in facilitating and improving safety for nurses and for patients, making reconstitution of the right dose easy to perform, at the patient’s bedside” highlights Dr. Olivier Chesnoy, CEO of Technoflex®.

Almac Group Invests to Expand its Existing North Carolina Facility

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Almac Group hasannounced the completion of an investment in its Durham, North Carolina Clinical Services’ and Diagnostic Services’ capabilities with the opening of a 24,000 sq. ft. building.

As part of Almac’s ongoing growth strategy, this significant expansion adds a fourth building to the Durham campus and provides additional office space for more than 100 new employees over the next three years. This additional capacity complements Almac’s existing Durham facility which offers a range of end-to-end clinical trial supply solutions to clients globally, as well as Almac Diagnostic Services which provides biomarker driven clinical trial solutions.

Donna Christopher, Global Vice President of Operations, Almac Clinical Services, commented:

“Almac’s exceptional quality is demonstrated by our dedicated employees, all of whom work hard to strengthen relationships for long-term collaboration. We are delighted that this further investment in our Durham facilities enables us to continue to support our clients’ needs and meet the increased demands for our integrated services. This expansion not only provides us with a stronger ability to service our growing customer base but it also serves to demonstrate our commitment to being the most trusted and stable name in the clinical supply marketplace.”
This expansion of service capacity comes shortly after the conclusion of Almac’s previous $5.2 million investment at the North Carolina facility in 2016, which saw the expansion of its Clinical Services operations along with the development of its Diagnostics and Clinical Technologies services. In its fifth decade of operations – with over twenty of these in North America – Almac’s commitment to be the partner of choice providing an array of innovative clinical solutions worldwide continues with ongoing expansion plans in development.

ARaymondlife and DARA were exhibiting the NFL line, compatible with RayDyLyo® plastic caps, during the last  CPhI at Madrid

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RayDyLyo® a breakthrough innovation with multiples benefits

RayDyLyo® is an all-plastic capping solution designed to work with all ISO stopper configurations (serum and lyo). Customers select and validate the stoppers which are assembled automatically by ARaymondlife. Pre-assembly of the stopper in the RayDyLyo® cap upstream simplifies the vial capping process to one-step in the isolator and eliminates the constraints associated with the crimping of aluminum caps.

 

A new filling line adapted to work with the RayDyLyo® cap is being presented at CPhI Madrid

In 2017, the Spanish company Dara Pharmaceutical Packaging worked closely with ARaymondlife to adapt its SX-310 filling line to work with RayDyLyo® closures. Equipped with a single vibratory bowl, the SX-310-RDL line has a reduced footprint compare to conventional lines, whilst maintaining quality standards.
Convinced by this first success, DARA and ARaymondlife decided to modify a new line for processing RayDyLyo® plastic push fit caps.

The NFL line is a line dedicated to the filling and capping of ready to use (RTU) nested vials, cartridges and syringes. This very compact machine requires no washing unit, no sterilization tunnel and no crimping station.

“A year ago, we worked with Dara to modify the SX-310 line for processing RayDyLyo® caps. Today, we are pleased to have achieved this same goal with the NFL line, so proving the ease of implementation of our RayDyLyo® solution for pharmaceutical companies,” says Pascal Sircoulomb, Business Development Director
of ARaymondlife.

With a filling and closing capacity of 4800 vials per hour, the NFL line offers a leading technical and economic solution for pharmaceutical companies and biotech companies looking for the flexibility to manufacture from small batches up to industrial series.

“Modifying our equipment to work with RayDyLyo® plastic caps was quick and easy, thanks to the close collaboration with ARaymondlife” says Joan Mele, Commercial Director at Dara Pharmaceutical Packaging. “Today we are able to offer a compact and multi format machine that makes it possible to close vials in one step, without de-nesting, in an aseptic area thanks to RayDyLyo®.”

“ARaymond is a large quality-orientated company that is always looking for long-term results, which is very important for making the investments
needed to achieve our goals. We share a common philosophy with them in terms of innovation and added value “says David Ral, General Manager of Dara.

The goal of DARA and ARaymondlife is to set up around 20 NFL filling lines over the next 3 years. Two machines are already functional and available immediately.

“We are confident that facilitating the implementation of RayDyLyo® on existing machines in the market, coupled with its many other economic and quality advantages will make our plastic capping solution, the new standard for vial capping” concludes Nicolas Thivant, President of ARaymondlife.