Unither Pharmaceuticals will attend the CPhI Worldwide 2017 in Frankfurt, Germany

unither logo

Meet Unither at Stand 4.1C80 on the 24-26 October 2017. This international partnering conference will be an excellent occasion to learn about their latest innovation: the orodispersible solutions. The orodispersible dosage forms have been developed to improve swallowing of oral dosage forms particularly for patients with dysphagia such as geriatric and pediatric population. 

Sanner invests in Bensheim production facility

Sanner

One year after its start, Sanner has successfully completed the “future project production area South”. During the project, the entire machine park in this area was replaced with 14 injection-molding machines of the latest generation. The Sanner team completed the project on schedule and within the designated budget. “Our goal was to further automatize production and consequently increase capacities and efficiency,” says Dirk Mähr, Managing Director of Sanner GmbH. “A goal we have definitely achieved.”

With this expansion, the company is taking another important step towards future-oriented production at its headquarters in Bensheim. The new injection-molding machines ensure faster processes and can be further automatized at any time. The packaging specialist is thus optimally equipped for the challenges of industry 4.0, as well as for further optimization projects. Over the next few years, Sanner will also consequently expand its portfolio in the areas of capsules and desiccant packaging.

“During the modification, we were also able to significantly reduce energy consumption in production in line with the Sanner sustainability concept,” Mähr adds. This includes, amongst others, a renewed media supply for cooling water and compressed air, a better raw material supply and the installation of new cranes. Thanks to new lighting and a reduced noise level, Sanner employees also benefit from easier workflows and better working conditions.

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
nemer

Gx® InnoSafeTM: customized for manufacturers and users

Ser

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.

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

Portrait 3

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.

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

almac

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

fareva-v2

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

catalent

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

Gerre Ok

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

03

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.”
01
Aptar Pharma Congers site, NY – Courtesy of Aptar Pharma