Nemera receives Drug Manufacturing Authorization for its Neuenburg plant, in Germany

Nemera

Important achievement for Nemera, now able to handle, assemble, sterilize and store pharmaceutical drugs and medicinal products for Autoinjectors.

On 4th September, Nemera received from the German Government Drug Administration (Government Presidium, Tübingen) the Pharmaceutical Drug Manufacturing Authorization according to §13 AMG (German Drug & Medicinal Product Law) at its Neuenburg manufacturing facility in Germany. The certification gives the manufacturing plant the approval to handle, assemble, sterilize and store pharmaceutical drugs and medicinal products for autoinjectors.

This approval reflects Nemera’s commitment to quality in developing and manufacturing drug delivery devices.

The Authorization is an important achievement. It confirms that Nemera meets the highest standards required to ensure the manufacturing and testing of the above-mentioned drug, as well as medicinal and medical products. The pharmaceutical drug manufacturing certification is a required regulatory step, in order to allow Nemera to provide a complete set of services and additional support, for the development and manufacturing of pharmaceutical combination products and drug delivery devices to our customers

“Achieving this pharmaceutical drug manufacturing approval is highlighting our commitment to ensure the safety of our drug delivery devices for the benefit of patients. It is also the confirmation that our quality systems and processes are meeting consistently regulatory requirements and patient expectations.” commented Christian Meusinger, Quality Vice-President of Nemera.

Neuenburg plant has been manufacturing high quality products since 1953.
With more than 20,000 sqm of built up area, the plant has Class 8 clean rooms and more than 400 employees, to guarantee a 7/7 and 24h/24 production.
Neunburg plant produces billions of Injection molded parts and assembled devices every year.

Neuenburg quality management key achievements are:

• Short reaction times
• Detailed and comprehensive root cause analysis
• Elimination of quality problems
• Reduction of scrap rates
• Elimination of inefficiencies
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Gx® InnoSafeTM: customized for manufacturers and users

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Gerresheimer presents at CPhI Worldwide in Frankfurt (Germany) an integrated safety system for the prevention of needlestick injuries

With their exposed cannulas, used syringes are an omnipresent source of danger in medical practices, 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 medical personnel. With Gx InnoSafe, Gerresheimer introduces a syringe with an integrated safety system for the avoidance of needlestick injuries that fulfils the current requirements of the pharmaceuticals industry and of users equally.

One careless movement is enough for medical specialists 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 additional actions. This thus involves a so-called passive needle protection system. Also of advantage to the pharmacists is the processing of the Gx InnoSafe syringes, which can take place on existing lines in the nested state without significant changes. An additional installation step of a safety system, as is usual on the market, is dispensed with.

The user wishes a safety system that leaves the familiar injection procedure unchanged, is intuitive and can be operated ergonomically, and which requires no additional manual activation to secure the cannula prior to disposal. The Gx InnoSafe  safety system is installed like a standard seal in the clean room on Gx RTF glass syringes in the context of the manufacturing process. The syringe body itself remains completely visible, so that the presence, filling level, and state of the active ingredient, as well as the injection procedure can be inspected without obstacles. The injection itself is administered as usual. Following the removal of the ergonomically optimized sealing cap with the integrated flexible needle shield, the syringe is positioned at the injection point, the cannula inserted into the tissue to be administered and the active ingredient injected as with a conventional syringe. An accidental triggering of the safety system isn’t possible, as the mechanism is completely relaxed prior to the injection. The system is first activated with the pricking 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 renewed use of the syringes is impossible.

bacFor the pharmaceuticals company, Gx InnoSafe offers advantages for the filling process of ready-to-fill syringes. The safety system is positioned fully automatically in the RTF process and visually inspected with an X-ray check to 100 percent for correct positioning. The syringes, including the safety system,  are packed in perforated trays and tubs and then sterilized with ethylene oxide gas. They can be processed on existing filling lines without additional preparation and assembly steps. Here too, the design of the safety mechanism ensures that unintended activation while filling, packaging, and transport is avoided. 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.

From October 24 to 26, Gerresheimer will be at CPhI Worldwide in Frankfurt (Germany) in hall 4.2 at booth D02.

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

Merck Set to Join Forces with Project Data Sphere to Pioneer Global Big Data Alliance

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Merck has announced that it will enter into a strategic collaboration with Project Data Sphere LLC, an independent, not-for-profit initiative of the CEO Roundtable on Cancer’s Life Sciences Consortium, to jointly lead the Global Oncology Big Data Alliance (GOBDA). This was announced at the signing of a Memorandum of Understanding yesterday, to coincide with Merck KGaA, Darmstadt, Germany’s, Award Ceremony announcing the recipients of its 2017 Grant for Oncology Innovation, held during the annual European Society for Medical Oncology Congress (ESMO 2017) in Madrid, Spain.

“The ultimate goal of our alliance with Project Data Sphere is to unleash the power of big data to bring value to cancer patients,” said Belén Garijo, Member of the Executive Board of Merck KGaA, Darmstadt, Germany, and CEO Healthcare. “Merck KGaA, Darmstadt, Germany, is deeply committed to investing in initiatives that push the boundaries of cancer research, that we hope will accelerate the discovery, development and delivery of innovative treatments to all who need it.”

The GOBDA initiative has been formed to expand the open-access of de-identified patient data sets to further enhance analytical capabilities, by building on Project Data Sphere’s innovative digital platform. The current platform contains historical clinical trial data from almost 100,000 patients provided by multiple organizations, and access to this information has already led to new and potentially practice-changing findings. GOBDA will expand this platform to include rare tumor trial, experimental arm and real-world patient data. Leveraging these data with big data analytics will help to optimize clinical trials, build a registry of data and help to enable advancement in the understanding of cancer treatment globally, with the mission to address the significant unmet needs in this field. In addition, by unleashing analytical power and big data to study and learn how to better manage rare but serious immune-mediated adverse events, institutes and industry will be able to assist regulators to adapt these new learnings into treatment guidelines. As well as establishing models to help enable early adverse event identification and improved patient outcomes.

“Big data is changing the face of healthcare as we know it, and advances in our ability to collect data, share and analyze it has already led to ground-breaking work,” said Dr Martin J. Murphy, CEO of Project Data Sphere LLC. “The joint force of Merck KGaA, Darmstadt, Germany, and Project Data Sphere will aim to connect and empower a truly global oncology community with these big data and analytical capabilities. We are excited about the Global Oncology Big Data Alliance initiative and the continuing engagement of a diverse community focused on finding solutions for cancer patients.”

Investment in the initiative builds on Merck KGaA, Darmstadt, Germany’s, commitment to rewarding innovation and creative thinking that could further advance the field of medicine, and begins a new chapter for global oncology innovation. Since 2014, the company has awarded a total of €4 million to further research in oncology through the Grant for Oncology Innovation award, which has engaged over 1,000 investigators worldwide, generated 12 winning research proposals from leading academic institutions, and generated seven high impact manuscripts.

OncoQR ML’s Vaccine Platform closes the Final Gap in the Immunological Attack against Cancer

T-cells attacking cancer cell  illustration of  microscopic photos

OncoQR ML GmbH has announced that even a single therapeutic vaccine based on its proprietary S-TIR™ platform technology, is able to induce the killing of tumor target expressing cells by simultaneously activating all possible immunological pathways (humoral and cellular).

Scientific Breakthrough

By showing this, the Austrian Biotech is the first company* to succeed in controlling all the relevant immune checkpoints that prevent the immune system from attacking and defeating cancer.

Whereas current passive checkpoint specific immunotherapy lacks tumor cell specificity with the risk of massive autoimmune reactions, this new active therapy is totally tumor target specific.

Geert Mudde, PhD, inventor of the S-TIR™ technology and OncoQR’s Chief Scientific Officer, said, “We are proud and excited to have finally demonstrated the ability to activate and use the full potential of the patient’s own immune system to eradicate cancer. Previously, we had already shown all forms of antibody mediated tumor killing – now we have the definite proof that our S-TIR™ vaccines are able to simultaneously induce and activate tumor specific T Cell killing as well. With our approach, the tumor has no more chance to escape the immune system – it is attacked from all possible sides at the same time.”

Economical Aspects

Christof Langer, Chief Executive Officer of OncoQR ML, said: “These spectacular results confirm the viability and huge potential of our proprietary S-TIR™ platform. Besides constituting a significant milestone in the development of our immunotherapy platform technology, to our knowledge, no other anti-cancer drug has shown comparable results so far. The new data are not only spectacular from a scientific point of view: The S-TIR technology will also break the trend that new cancer therapies have to be unethically expensive. Our therapeutic vaccines are designed to have low cost of goods which is paired with a personalized low treatment frequency at low treatment dose. Drugs based on our technology can be used as monotherapy but can also be combined with existing therapies (like chemotherapy). Therefore, all in all, groundbreaking news for patients, and healthcare organizations, but of course also for us and our future partners.”

Aptar Pharma to Highlight Key Innovations Addressing Today’s Megatrends in Drug Delivery at CPHI Worldwide in Frankfurt, Germany

Aptar

Aptar Pharma, a leading drug delivery systems provider, is pleased to once again be a main exhibitor at CPhI Worldwide 2017, which takes place in Frankfurt, Germany from October 24 – 26. For many years, Aptar Pharma has had a significant presence at this major event in the pharmaceutical industry.

This year, the Aptar Pharma booth, located at stand No. 42F10, Hall 4.2., will feature an innovation area showcasing seven healthcare technology megatrends, including a special connectivity hub, which will be dedicated to the growing field of connected healthcare solutions.

In addition to exhibiting at CPhI Worldwide, Aptar Pharma will present three Pharma Insight Briefings that will highlight its latest innovations and developments in the following drug delivery system areas:

 

Innovative Respiratory Solutions for Expanding Your Product Portfolio

Portrait 1Guenter Nadler, Director of Business Development at Aptar Pharma, will deliver an insightful talk on innovative respiratory solutions on the first day of CPhI Worldwide. As a global rise in allergies and air pollution have led to a significant increase in upper respiratory tract diseases, typical over-the-counter medications and household remedies cannot always fulfil the needs of today’s on-the-go lifestyle.

As one of the leading drug delivery system providers for the development of dispensing solutions for pharmaceutical cough and cold applications, Aptar Pharma’s proven nasal spray and Bag on Valve systems have become the treatment standard in the industry.
During the talk, attendees will learn more about how these systems meet today’s requirements for compliant patient treatment.

Join Guenter’s Briefing on Tuesday, October 24 at 10:30 at the Innopack Zone, G1A3.

 

Driving Better Patient Outcomes with Connectivity

Portrait 2Sai Shankar, Director Business Development – Connected Devices at Aptar Pharma, will present the company’s second Pharma Insight Briefing at CPhI Worldwide.

Using a patient-centric design approach, Aptar Pharma supports Pharma companies worldwide with custom-made solutions, including connected technologies, for the treatment of respiratory diseases including asthma and COPD. The findings of a study recently conducted by Aptar Pharma on its integrated connected pMDI, as well as the company’s connected health devices portfolio that support respiratory treatment for patients, will be among the topics presented at this briefing.

Join Sai’s talk on Tuesday, October 24 at 15:50 at the Innopack Zone, G1A3.

 

Setting New Standards for Coated Stoppers

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Arnaud Fournier, Business Support Manager for Injectables at Aptar Pharma, will exclusively introduce PremiumCoat ™, a coated stopper which represents a step change in the provision of elastomeric stoppers with an unrivalled, market leading reduction in particulates, and is Aptar Pharma’s response to the growing challenges to developing more sensitive drugs in the pharmaceutical market.

Join Arnaud’s presentation on the latest development in Aptar Pharma’s Premium Injectables portfolio on Wednesday, October 25 at 10:30 at the Innopack Zone, G1A3.

With over 42,000 Pharma professionals attending CPhI Worldwide every year, Aptar Pharma welcomes the opportunity to meet with their valued customers and business partners, exchange with key opinion leaders in the Pharma industry and showcase their latest key innovations.

Join Aptar Pharma at booth No. 42F10, Hall 4.2, where their team of experts will be pleased to give an overview of their wide product portfolio that provides innovative drug delivery systems, components and services covering a broad range of delivery routes.

Lilly and Nektar Therapeutics announce alliance to develop a novel autoimmune therapy

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Eli Lilly and Company and Nektar Therapeutics have announced a strategic collaboration to co-develop NKTR-358, a novel immunological therapy discovered by Nektar. NKTR-358, which achieved first human dose in Phase 1 clinical development in March of 2017, has the potential to treat a number of autoimmune and other chronic inflammatory conditions.

NKTR-358 is a potential first-in-class resolution therapeutic that may address an underlying immune system imbalance in patients with many autoimmune conditions. It targets the interleukin (IL-2) receptor complex in the body in order to stimulate proliferation of powerful inhibitory immune cells known as regulatory T cells. By activating these cells, NKTR-358 may act to bring the immune system back into balance. This could lead to a profound clinical impact and healthy organ function in autoimmune conditions.

“We look forward to working with Nektar to study this novel approach to treating a number of autoimmune conditions,” said Thomas F. Bumol, Ph.D., Senior Vice President of Biotechnology and Immunology Research at Lilly. “NKTR-358 is an exciting addition to our immunology portfolio and reinforces Lilly’s commitment to sustain a flow of innovative medicines in our pipeline.”

Under the terms of the agreement, Nektar will receive an initial payment of $150 million and is eligible for up to $250 million in additional development and regulatory milestones. Lilly and Nektar will co-develop NKTR-358 with Nektar responsible for completing Phase 1 clinical development. The parties will share Phase 2 development costs 75 percent Lilly and 25 percent Nektar. Nektar will have the option to participate in Phase 3 development on an indication-by-indication basis. Nektar has the opportunity to receive double-digit royalties that increase commensurate with their Phase 3 investment and product sales. Lilly will be responsible for all costs of global commercialization. Nektar will have an option to co-promote in the U.S. under certain conditions.

“We are very pleased to enter into this collaboration with Lilly as they have strong expertise in immunology and a successful track record in bringing novel therapies to market,” said Howard W. Robin, Nektar’s President and Chief Executive Officer. “Importantly, this agreement enables the broad development of NKTR-358 in multiple autoimmune conditions in order to achieve its full potential as a first-in-class resolution therapeutic.”

Almac Discovery is Granted Orphan Drug Designation for ALM201 Programme in Ovarian Cancer

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Almac Discovery, has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its drug candidate ALM201 in the treatment of ovarian cancer.

ALM201 is a therapeutic peptide developed to mimic some of the properties of the naturally occurring protein FKBPL. The development of ALM201 by Almac Discovery builds upon initial research work by Professor Tracy Robson who has shown that FKBPL is a naturally secreted protein with effects on a number of important tumour biology processes including cancer stem cells and angiogenesis.

Ovarian cancer ranks among the top ten diagnosed and top five deadliest cancers in most countries. Unfortunately, approximately 80% of patients present with advanced disease, therefore it is critical that clinicians are provided with as many treatment options as possible which can target this disease, either as a monotherapy or in combination with other treatments.

Dr Stephen Barr, Managing Director & President, Almac Discovery commented “The FDA’s Orphan Drug Designation of ALM201 in the treatment of ovarian cancer will allow for valuable assistance from the FDA during clinical development for either ourselves or our partners for this difficult to treat patient population.”

The FDA Office grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.

Fareva Excelvision completed a 30 mEUR+ investment in ophthalmics manufacturing capabilities

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Fareva Excelvision has just completed the validation of its new versatile ointment / gel IWK line able to handle up to 10 g tubes made of tin, aluminium or polyfoil.

Additionally 2 new 4010 Rommelag BFS (Blow Fill Seal) line has been also validated in a new workshop to increase the site capacity close to 900 millions of single dose units per year. New flow packs machines also allow to package the strips in a convenient and safe way to protect the products from water evaporation and light, ensuring product integrity even in hot climates.

In addition to those major investments, Fareva is also able to fill the preservative free bottle technology of Nemera (Novelia system), including the manipulation of cyclosporine.

Fareva is also ready for serialization up to the level 4 to support all the new regulatory expectations.

If you want to know more about Fareva, please do not hesitate to contact pharma@fareva.com

Catalent Launches New OptiForm® Solution Suite To Offer Quick And Efficient Path From Late-Stage Discovery To Phase I Clinical Trials

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Catalent Pharma Solutions has announced the broadening of the scope of its multi-award winning OptiForm® Solution Suite platform to provide an efficient and seamless path from late-stage discovery to phase I clinical trials.

Designed to make it easier and faster for small and mid-sized innovators to develop better treatments, the new OptiForm Solution Suite service will now include more comprehensive candidate screening tools, Absorption, Distribution, Metabolism and Excretion (ADME) considerations and in silico Drug Metabolism and Pharmacokinetic (DMPK) modeling, additional bioavailability enhancing tools, materials for cGLP intravenous and oral toxicological studies, and cGMP materials for first-in-human studies.

Built on Catalent’s experience in early phase development, which has seen the company support more than 500 Investigational New Drugs (INDs), the new OptiForm Solution Suite integrates tools and services sequentially to deliver relevant data and an optimized development program to support a molecule’s progress towards the clinic.

“To ensure a program’s success, formulation selection needs to be guided by a phase-appropriate model that measures and evaluates the right data at the right time,” commented Julien Meissonnier, Catalent’s Vice President, Science & Technology. “The service provides innovators with a progressive, data-driven approach to maximize options that demonstrate in vivo efficacy and activity, acceptable safety margins in preclinical models, better downstream processing attributes, and optimal dose design for the intended patient group; supporting the selection of a development candidate with the best chances of success in the clinic and beyond.”

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