Almac Group Announces Acquisition of BioClin Laboratories and Significantly Expands its Analytical Services

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Almac Group, the global contract development and manufacturing organisation, has announced the acquisition of BioClin Laboratories, an independent and privately owned organisation based in Athlone, Ireland.

Established in 2002 and located in Garrycastle, just two hours away from Almac Group’s Headquarters in Northern Ireland, BioClin is internationally recognised for providing expert analytical services including cGMP pharmaceutical and biopharmaceutical analysis, GMP microbiology testing and GLP bioanalysis. The company also boasts Ireland’s leading GLP certified (INAB), cGMP certified (HPRA) and FDA registered contract laboratory.

BioClin’s bespoke 14,000sq ft modern facility significantly increases Almac’s analytical capacity and perfectly complements its existing business enabling strategic expansion and greater ability to serve clients’ needs globally. The acquisition will see BioClin’s analytical experts join Almac Sciences’ strong network of almost 600 employees across multiple sites in Europe and North America.

Almac also recently completed significant expansion of its existing analytical facilities at its global headquarter site in Northern Ireland with the creation of a new, bespoke, MHRA approved laboratory.

News of this acquisition comes just days after announcing a multi-million pound expansion of Almac owned, Arran Chemical Company, also based in Athlone, which substantially increased Almac’s manufacturing capacity for fine chemicals, pharmaceutical intermediates and advanced building blocks.

“We are delighted to announce this acquisition demonstrating further commitment to strategic growth and development of our global business.” stated Dr Stephen Barr, Managing Director, Almac Sciences. “Adding BioClin’s highly complementary analytical capacity and technical expertise to our existing capabilities, we are able to broaden our service offerings and address our global clients’ growing demands for a high quality, integrated, efficient service. We look forward to working with the BioClin team and plan to invest significantly in this facility.”

Mary Burke, Managing Director, BioClin Laboratories commented “We are very pleased to join Almac. With our shared values for outstanding quality, expertise and innovation we see this as an excellent strategic fit for BioClin enabling us to expand and deliver an enhanced range of analytical solutions to an international client market.”

AptarGroup wins Sustainability Initiative of the Year at CPhI Pharma Awards

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AptarGroup announced that it was awarded the inaugural Excellence in Pharma: Sustainability Initiative of the Year at CPhI Worldwide 2017. The award was presented as part of the CPhI Pharma Awards Gala, which took place Tuesday, October 24 at the Intercontinental Hotel in Frankfurt, Germany.

Established in 2004, the CPhI Pharma Awards are one of the most prestigious recognitions in the Pharmaceutical industry today. This year’s awards included eight new categories to further reflect the industry’s diversity. The Sustainability Initiative of the Year is one of this year’s new categories. There were over 200 entries across the 19 award categories, and finalists for the awards were announced in August 2017.

Aptar was awarded the Excellence in Pharma: Sustainability Award for its Landfill Free Certification program, a global internal certification program which promotes the efficiencies and conservation of natural resources in a manufacturing setting. Facilities that achieve at least a 90 percent reuse and/or recycling threshold are eligible to receive internal Landfill Free Certification. With more than 40% of Aptar’s manufacturing sites already certified through this program, Aptar has achieved significant accomplishments in waste reduction, cost savings and employee engagement. The program is incorporated as a measurable aspect of Aptar‘s global sustainability strategy and Aptar anticipates more facilities will achieve certification in years to come.

Data from Aptar’s recent customer satisfaction surveys demonstrated the growing importance of sustainability to customers and supply partners. Therefore, Aptar’s internal program further reinforces that Aptar is prioritizing the needs of its customers in line with its own company mission and corporate social responsibility.

Yann Ghafourzadeh, VP, Sales & Operations Europe – Prescription Division, commented, “We are delighted to have been awarded the Sustainability Initiative of the Year at the CPhI Pharma Awards. It is great to be recognised for the progression of Aptar’s Landfill Free Certification program, which has been significant within our global sustainability strategy. We have aligned our program with our customers’ requirements and we are dedicated to responding to what sustainability considerations are important to them. We look forward to further Aptar facilities obtaining the internal Landfill Free Certification in the future.”

Pre-diabetes discovery marks step towards precision medicine

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Researchers from the University of Sydney’s Charles Perkins Centre have identified three specific molecules that accurately indicate insulin resistance, or pre-diabetes – a major predictor of metabolic syndrome, the collection of medical conditions that include abdominal obesity, high blood pressure and high blood sugar levels.

The finding, from a study undertaken in mice, could make earlier detection of pre-diabetes in humans much easier for doctors and allow for more personalised and effective treatments for patients in the future.

Researchers combined the high-tech mathematical approach of machine learning with omics technology that examines the various types of molecules that make up the cells of an organism to successfully identify specific molecules in mice. That information was used to classify the mice according to what kind of food they eat, their genetic origin and their whole-body insulin sensitivity.

Published in the Journal of Biological Chemistry, the research was conducted with the Garvan Institute of Medical Research, Duke University (USA) and the University of Melbourne.

 

Technology key to uncovering factors that contribute to pre-diabetes

Co-lead author Dr Jacqueline Stöckli, a research fellow with the University’s Charles Perkins Centre and School of Life and Environmental Sciences, said the study suggested there are likely multiple factors that contribute to pre-diabetes and this is why more traditional approaches have failed to identify similar highly predictive signatures or indicators of disease.

“Our study identified a three molecule signature that was able to diagnose insulin resistance or pre-diabetes, a condition that is often associated with diabetes, obesity and high blood pressure,” she said.

“But we know the story is much more complicated; strikingly, each of the three molecules on their own was considerably less predictive of pre-diabetes than when combined.

“The next step is to further exploit these technologies to uncover the full suite of pathways and factors that contribute to pre-diabetes – which will include genetic, environmental and possibly epigenetic influences – at a population level.”

 

Customised treatments for pre-diabetes patients step closer

The study represented a segue into precision medicine for humans, said senior author Professor David James, Leonard P. Ullmann Chair of Metabolic Systems Biology at the Charles Perkins Centre.

Precision medicine classifies individuals according to their susceptibility or response to a particular disease, and tailors healthcare treatments and practices accordingly.

“Once we can identify the molecules and other factors that contribute to pre-diabetes, we can customise treatments to suit patients’ specific make up and needs,” Professor James said.

“This study demonstrates the power of combining technologies to solve some of the world’s biggest problems,” he added.

“The burden of the ‘lifestyle diseases’ the Charles Perkins Centre is dedicated to easing – which include obesity, diabetes and cardiovascular disease – stubbornly remain at high levels globally; we need to innovate in order to tackle these conditions effectively.”

Using Social Media Big Data to Combat Prescription Drug Crisis

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Researchers at Dartmouth, Stanford University, and IBM Research, conducted a critical review of existing literature to determine whether social media big data can be used to understand communication and behavioral patterns related to prescription drug abuse. Their study found that with proper research methods and attention to privacy and ethical issues, social media big data can reveal important information concerning drug abuse, such as user-reported side effects, drug cravings, emotional states, and risky behaviors.

Their work, “Scaling Up Prescription Drug Abuse and Addiction Research Through Social Media Big Data,” is reported in the Journal of Medical Internet Research.

Prescription drug addiction is a well-known nationwide problem. Many people who are unable to get help for their addiction seek out peer support groups on Facebook or other social media platforms to share stories about their experiences and also provide social peer-based support.

Lead author, Sunny Jung Kim, PhD, an e-health communication scholar in the departments of biomedical data science and psychiatry at Dartmouth’s Geisel School of Medicine, says that because we are prolific consumers of social media, which is not limited to geography—globally, people spend more than two hours every day on social media platforms generating vast amounts of big data about our personal communications and activities—we can use these platforms to enhance public health communication strategies to help people on a large scale.

“Harnessing social media platforms and data can provide insight into important novel discoveries of collective public health risk behavior, a better understanding of peoples’ struggles with addiction, and their process of recovery,” Kim says. “I started this project because there were few studies about why people use social networking sites to share unsolicited, highly personal information about their drug use, nor about the psychological effects or consequences of this type of user-generated communication.”

Co-author Jeffrey Hancock, PhD, a professor in the department of communication and the director of computational social science at Stanford University, says, “Given the importance of this problem for the U.S. population, it’s imperative that we understand how social media is playing a role and how it can be part of the solution.”

Based on their findings, the researchers designed an evidence-based, multi-level framework to inform future social media-based substance use prevention and recovery intervention programs.

“Our review and typology suggests that social media big data and platforms can be a tremendous resource for monitoring and intervening on behalf of people with drug addiction and abuse problems,” Kim says.

Russian biotechnology company BIOCAD prepares to enters the European market

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The largest Russian biotechnology company BIOCAD plans to enter the European market with oncological and autoimmune medicines. So far, there are seven molecules in the European portfolio of BIOCAD. This are innovative and biosimilar products, which could be used in treatment of melanoma, breast, stomach, kidney and lung cancer, rheumatoid arthritis, psoriasis and multiple sclerosis.

“The presence of Russian innovative medicines on the European market depends on the speed of approval process in the EMA (European Medicines Agency) which correlate with readiness to provide sufficient documents from manufacturer. BIOCAD is the only pharmaceutical company in Russia, which is ready to provide dossiers for its medicines according to ICH CTD format in the shortest possible time, “says Dmitry Morozov, general director of BIOCAD biotechnological company. In addition, the advantage of BIOCAD is its own production plant, which the company builds in Finland, in the city of Turku.

Currently, the Russian pharmaceutical company BIOCAD has not only biosimilars and generics in its pipeline, but also original molecules for the treatment of oncological and autoimmune diseases. The company invests in clinical trials of all this products. The last preparations are underway for conducting European Phase III clinical trials of adalimumab biosimilar and the original anti-IL-17 molecule. The preliminary agreement for the distribution of adalimumab in the European Union countries is planed to be signed in Frankfurt at CphI exhibition.

“As for the EU countries, where the approval of biological product goes under centralized procedure through the European Medicines Agency, taking into account the need for local clinical trials, we expect to get marketing authorization for biological products in 2021,” says Dmitry Morozov. In addition, in 2021, the generics of oncology drugs – docetaxel, paclitaxel, pemetrexed and irinotecan – will also enter the European countries.

BIOCAD is interested in licensing innovative products from small companies on mutually favorable terms for the Russian market. During the visit to Frankfurt, Russian experts will discuss with their Swiss colleagues the prospects of collaboration on a drug against hard-to-treat chronic viral infections based on a molecule obtained in the laboratories of the Swiss company. In addition, the company plans to sign a preliminary agreement on the licensing of an immune-oncology molecule with a pharmaceutical company from Germany. This drug will be used in combination therapy of some cancers along with the original BIOCAD medicine.

Novartis announces the planned acquisition of Advanced Accelerator Applications to strengthen oncology portfolio

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Novartis has announced, that it has entered a memorandum of understanding with Advanced Accelerator Applications (AAA) under which Novartis intends to commence a tender offer for 100% of the share capital of AAA subject to certain conditions. Advanced Accelerator Applications is a radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicines including Lutathera® , a first-in-class RLT product for neuroendocrine tumors (NETs). Radiopharmaceuticals, such as Lutathera, are unique medicinal formulations containing radioisotopes which are used clinically for both diagnosis and therapy. The transaction would strengthen Novartis’ oncology presence with both near-term product launches as well as a new technology platform with potential applications across a number of oncology early development programs.

“Novartis has a strong legacy in the development and commercialization of medicines for neuroendocrine tumors where significant unmet need remains for patients,” said Bruno Strigini, CEO, Novartis Oncology. “With Lutathera we can build on this legacy by expanding the global reach of this novel, differentiated treatment approach and work to maximize Advanced Accelerator Applications broader RLT pipeline and an exciting technology platform.”

Lutathera was approved in Europe in September 2017 for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Lutathera is under review in the U.S. with a Prescription Drug User Fee Act (PDUFA) date of January 26, 2018.

The efficacy and safety of Lutathera were established in the pivotal Phase III trial known as NETTER-1. The primary endpoint of the study was progression free survival with secondary endpoints including objective response rates, overall survival, safety and tolerability. The study met its primary endpoint with Lutathera achieving statistically significant and clinically meaningful 79% reduction in risk of disease progression or death compared to the control therapy (hazard ratio 0.21, 95% confidence interval: 0.13-0.33, p<0.0001). At the time of study publication in the New England Journal of Medicine (January 2017), median PFS in the control arm was 8.4 months and had not yet been reached in the Lutathera arm.

In addition to Lutathera, AAA brings a broad set of skills in developing, manufacturing and commercializing radiopharmaceuticals, including the companion diagnostics for Lutathera (NETSPOT® and SomaKit TOC(TM)). AAA had sales of EUR 109 million in 2016.

ARaymondlife continues to develop and commercialize its RayDyLyo® range collaborating with Dara Pharmaceutical Packaging.

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• RayDyLyo®, an innovative device for vial capping

ARaymondlife is a pharmaceutical company GMP EU, specialized in plastic injection molding and fastening solutions. Its technological expertise is applied to develop innovative solutions for the pharmaceutical laboratories (for human health and veterinary medicine) and the medical industry.
Since 2012 ARaymondlife has been offering its own range of patented all plastic caps as an alternative to aluminum crimped closures. RayDyLyo® is more than a product; it is a solution that simplifies and improves the process security of the vial capping operation. Several packaging options are available in bulk or in nests to meet the market’s diverse needs. The trend toward ready-to-use components and filling vials directly in nests makes RayDyLyo® a very well-adapted solution.
RayDyLyo® eliminates the need for crimping by pre-assembling the stopper in the cap and closing the vial by simple vertical pressure, either automatically or manually.

• The first filling line adapted for RayDyLyo®

ligne DARA_AR - copieDara Pharmaceutical Packaging was showing the first vial filling line specially adjusted for filling and capping vials with RayDyLyo® at the CPhl in Frankfurt (24-26 October 2017).The Spanish company responded to ARaymondlife’s request to develop a suitable machine for feeding the all-in-one solution (a stopper pre-assembled in the plastic closure) and the specific parts needed to adapt the line.
Pre-assembling the stopper upstream simplifies the process compared to a traditional line by eliminating thestopper placing and crimping operations and saves space in the clean room.

« We believe that this first filling line will be introduced to the market progressively, but we are convinced that this product will gain significant market share in the medium term. DARA new vials filling lines, are ready to implement this new technology. Also and this is the most important thing, DARA old machinery, due to its modularity construction, allows an easy, economical and fast retrofit, to combine this new RayDyLyo® system with the traditional stopper and alu cap technology. RayDyLyo® is a highquality product that fits perfectly with Dara’s filling lines. » Joan Melé, Dara Pharmaceutical Packaging Commercial Director.

For its development, ARaymondlife has already concluded other partnerships, in particular with the “Matrix Alliance”, on the initiative of Vanrx Pharmasystems, allowing to propose an aseptic filling solution in a fully robotized isolator, or more recently with Disposable-Lab Eurofins Amatsigroup to offer to biotechs and pharmaceutical companies a global solution for the aseptic filling of innovative biological products.
“We want to continue to develop industrial partnerships such as the one with Dara Pharmaceutical Packaging because we are convinced that we are stronger together and that the answers we bring to the market are more relevant,” explains Nicolas Thivant, President of ARaymondlife.

• Innovation and diversity are part of ARaymond’s DNA

Discovering new markets where its know-how and its potential for innovation make sense has been the driving force behind ARaymond’s development for more than 150 years. As one of the world leaders in fastening and assembly solutions for the automotive industry, it has gradually transferred its skills and expertise to new markets: Truck, Industrial, Energies, Agriculture and Life.
« We believe in ARaymondlife’s potential because it is an ambitious project driven by the passion and involvement of the people who lead it and it respects the values of our company. We are convinced that our employees’ enthusiasm and motivation will make a difference over the long term, » says François Raymond, General Director of the ARaymond Network. For the company, diversification also means ensuring its stability and independence despite the political and economic uncertainties that may affect a sector or a country.

Catalent Collaborates With Grid Therapeutics To Develop A Novel Targeted Immuno-Oncology Therapy

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Catalent Pharma Solutions has signed a multi-year agreement with Grid Therapeutics, LLC, for the development and manufacture of Grid’s lead therapeutic candidate for the treatment of solid tumors. Grid is an oncology-focused biotech company building on the innovative science first developed by Edward F. Patz, Jr. MD, and his team of scientists at Duke University Medical Center.

Under the agreement, Catalent Biologics will employ its proprietary GPEx® cell line technology to develop cell lines and manufacture antibodies with a view to optimizing the process for cGMP bulk drug production. The project will be undertaken at Catalent’s state-of-the-art Madison, Wisconsin, biomanufacturing facility.

Grid’s research is based upon a novel approach to identify specific tumor immunoglobulin G (IgG) antibodies from patients with early stage cancer. Grid used a unique strategy to obtain the sequence of its lead IgG3 antibody directly from B cells in cancer patients.

“Grid Therapeutics is excited to partner with Catalent to develop this novel, human-derived antibody for the treatment of cancer. We feel Catalent Biologics is well positioned to bring this novel antibody to the clinic,” commented Edward F. Patz, Jr. M.D., CEO of Grid Therapeutics.

“Catalent regularly and successfully partners with innovator companies looking to bring new, important therapies to market faster, and a patient derived IgG3 monoclonal antibody would be a significant advancement in optimized treatments,” commented Mike Riley, Vice President & General Manager of Catalent Biologics.

Catalent’s proprietary GPEx technology creates stable, high-yielding mammalian cell lines with high speed and efficiency. The advantages of applying GPEx technology span from early feasibility studies, to clinical manufacturing, through to commercial-scale production. To date, seven GPEx-based antibody and protein products are approved and marketed, and 34 therapeutic candidates are currently in the clinic across the world.

Gx® InnoSafeTM: Optimal for pharmaceutical companies and healthcare professionals

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Gerresheimer was presenting at CPhI Worldwide in Frankfurt (Germany) an integrated and passive safety system for the prevention of unintentional needlestick injuries.

With their exposed cannulas, used syringes are an omnipresent source of danger in doctor’s surgeries, labs, or hospitals. Existing needle protection systems reduce the risk of injury for the user, but require additional effort for filling on the part of the pharmaceutical companies and with respect to the use of the syringe by healthcare professionals. With Gx® InnoSafeTM, Gerresheimer now offers a syringe with an integrated and passive safety system that prevents unintentional needle stick injuries, excludes the possibility of accidental reuse and takes the needs of pharmaceutical companies and health care professionals equally into account.

One careless movement is enough for healthcare professionals to injure themselves on unprotected, used syringe cannulas or come into contact with aggressive active ingredients. In the most adverse case, this can result in serious infections. There is also a danger that already used syringes may accidentally be used a second time. Gx InnoSafe provides reliable protection against needlestick injuries and eliminates the possibility of reuse. In contrast with many existing solutions, the needle protection mechanism is thereby activated automatically and requires no further handling steps by the end user. This thus involves a so-called passive needle protection system. Also of advantage to the pharmaceutical companies is the processing of the Gx InnoSafe syringes, which can take place on existing filling lines in the nested state without significant changes. An additional assembly step of a safety system, as is usual on the market, is dispensed with.

SerThe user wants to have a safety system which remains the injection process unchanged, ensures an intuitive and ergonomical handling and does not require any additional operating steps for securing the cannula prior to disposal. The Gx InnoSafe safety system is installed like a standard needle shield in the clean room on Gx RTF glass syringes in the context of the manufacturing process. The syringe body is completely visible in order to be able to optimally see and check the presence of the active agent, its purity and the administering. The injection itself is administered as usual. Following the removal of the ergonomic sealing cap with integrated flexible needle shield, the syringe is positioned at the injection point, the cannula inserted into the tissue and the active ingredient injected like with a conventional syringe. An accidental triggering of the safety system is prevented, as the mechanism isn’t preloaded prior to the injection. The system is first activated with the piercing of the cannula and then automatically ensures when removing the syringe from the injection point that the safety mechanism is permanently locked. In this way, the cannula is reliably covered and reuse of the syringes is excluded.

For the pharmaceutical company, Gx InnoSafe offers advantages for the filling process of ready-to-fill syringes. The safety system is installed fully automatically like a standard needle shield in the clean room onto Gx RTF glass syringes and checked to 100 percent by visual inspection for potential needle piercing and safety system position. The syringes are then packaged, sealed and sterilized with ethylene oxide gas including the safety system in a 100 hole tray (nest) and in a tub. They can be processed on existing filling lines without additional preparation and assembly steps. The design of the safety mechanism ensures that unintended activation while filling, packaging, and transport is avoided. The flexible needle shield is available in all customary available elastomers for pharmaceutical applications. With the introduction of the new product line Gx InnoSafe is available for the 1.0 ml long RTF glass syringe with a ½“ cannula. Additional syringe variants will follow.

Gx® and RTF® are registered trademarks of the Gerresheimer Group. InnoSafe is a pending trademark of the Gerresheimer Group.

Stiplastics opens a new factory in Saint-Marcellin (France) dedicated to the future of healthcare

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Stiplastics, the specialist designer, developer and producer of plastic solutions for the pharmaceutical industries and the health and e-health sectors has opened its new factory in Saint-Marcellin. A total of €8.6 million has been invested in this site, enabling the company to pool all its operations and meet its customers’ various requirements, especially in terms of the increasing demand for connected health.


A cutting-edge production tool

The 10,000 m2 site in Saint-Marcellin in the French département of Isère includes the company’s administrative headquarters, design office and production workshops (injection, assembly, storage) where manufacturing is based on lean management principles. It has:

– A dedicated injection workshop with 23 electric injection moulding machines weighing 30 to 300 T
– An automated assembly area (camera inspections, robot stations) and storage area
– A test centre with a dedicated injection moulding machine

In response to the rise of e-health, Stiplastics has also set up a new electronics workshopequipped with special tools including test benches. This 150 m² space is protected from ESD (Electro Static Discharge) by a controlled environment essential for handling electronic components.
The increasing prominence of connected care has also prompted the company to set up IoC  [Internet of Care]®. This label and unit is dedicated to designing, developing and producing ehealth medical devices, with the main aim of significantly improving treatment and patient comfort.

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Stiplastics is therefore now able to design and manufacture medical devices, add electroniccomponents, test them and then pack them ready-to-use for delivery.

‘In 2013, we drew up a development plan forecasting almost doubled sales in five years. This investment will enable us to meet our targets since we are still on track for turnover of €23 million by the end of 2018. It would not have been possible to build this new site so quickly without the effective contribution made by our staff, which I would like to acknowledge, and the unfailing support of the local authorities, especially the Pays de Saint-Marcellin Community of Municipalities and the City of Saint-Marcellin, who I would like to sincerely thank,’ says Jérôme Empereur, CEO of Stiplastics.

‘Since 2014, when we entered a true partnership with Stiplastics, immense progress has been made with connected health, a sector that gives much hope, especially in terms of allowing patients to continue living at home. This public health issue is particularly challenging for less urban local authorities like our own. We are therefore happy and proud to have supported and gained the loyalty of an innovative company involved in the future of healthcare. Its dynamism adds to the appeal of our community of municipalities and, we hope, will encourage other companies to set up in our booming region set in an ideal location at the foot of the Vercors mountains near major motorway links,’ explains Frédéric de Azevedo, head of the Saint-Marcellin Vercors Isère Communauté community of municipalities.