Gerresheimer complements its primary packaging portfolio introducing ready-to-fill vials

Gerresheimer-AG-leading-supplier-to-global-pharma-and-healthcare-industry_

Gerresheimer will enhance its portfolio by adding Gx RTF vials. Ready-to-fill or ready-to-use vials are the state of the art solution to fulfill customer requirements regarding quality, flexibility and less complexity. To achieve this, Gerresheimer and Ompi have signed a mutual agreement in order to allow Gerresheimer to use the Ompi EZ-fill packaging technology. The new products will provide the customers with more flexibility: either with small batches, initially at the clinical trials stage, or with industrial production.

“Our new portfolio will meet the growing demand for comprehensive solu-tions. Together with Ompi we will make a further step towards establishing one standardized platform for ready-to-fill vials, which make the customer process very easy and smooth,” said Uwe Röhrhoff, CEO of Gerresheimer AG.

“We’re glad our leading technology has been adopted by Gerresheimer. Our solution, which has proved to be scalable, will benefit the customer with more flexibility, increased quality and safety and quicker time to market,” said Mauro Stocchi, General Manager Pharmaceutical Systems division at Stevanato Group.

Vials are the standard primary packaging for parenteral drugs. Gerres-heimer offers vials in all sizes corresponding to international standards and pharmacopoeia requirements. The Gerresheimer offering does include solutions for biotech and other specialist pharma drugs. The new Gx RTF vial portfolio will be based on already established quality offerings for vials like PharmaPlus and Elite Glass. By adapting this knowledge to vials and combining it with the well-established Ompi EZ-fill packaging solution provides added value to customers, enabling them to source one identically packed vial from two suppliers.

Ready-to-fill vials are washed and sterilized solutions provided in trays or in nests and tubs. The pharmaceutical customer can immediately fill the ready-to-fill vials without any further process. Gerresheimer has been producing RTF glass syringes (ready to fill) for more than 15 years already and has recently launched RTF COP syringes produced in Europe.

More information about:
Gx RTF vials powered by Ompi EZ-fill: www.gerresheimer.com/en/products/pharmaceutical-primary-packag-ing/vials-sterile-made-of-glass
Gx RTF syringes: www.gerresheimer.com/en/products/pharmaceutical-primary-packaging/syringes-made-of-glass
More information about Ompi EZ-fill (Ompi): www.ez-fill.com

Contact for Europe: Maximilian Vogl, Gerresheimer Medical Systems, m.vogl@gerresheimer.com
Contact for USA: Robert Hayes , Gerresheimer Primary Packaging Glass, r.hayes@gerresheimer.com

Innovation with Plastibell

Plastibell 1

PLASTIBELL is a well-established international player in injection moulding for the healthcare market.
The company is investing significant resources into the development of its Innovation Cell in order to deliver appropriate solutions to the challenges of the healthcare sector and better meet the future needs of its customers.

 

 

Innovation “by PLASTIBELL” brought its contribution to the Pharmapack 2017 exhibition through an interactive module in which it presented its vision, programs, expertise and means of innovation.

Innovation “by PLASTIBELL” lays a special focus on the integration of all the players involved in product creation:

– The client and the user
– The partners (sharing of know-how)
– The regulations

With its Innovation Cell, Plastibell adds an essential feature to its value offering, by positioning itself on three areas of expertise:

Partner & Developer (high complexity): innovation (concept proposal) and co-development of new products, regulatory affairs.
Supplier – Industrialization (average complexity): development, methods and industrialization
Subcontractor of capabilities (low complexity): production, quality system, logistics

Plastibell 2

New award for Nemera with Safelia®

Safelia_1ml_HD_jan17

Nemera has won the ‘Editor’s choice’ category at the annual INTERPHEX Awards, for its 2 steps-autoinjector Safelia®

INTERPHEX and a team of industry experts select Nemera as winner for this year’s exhibitor awards as Editor’s choice

Safelia® is an innovative autoinjector for prefilled syringes, available for 1 and 2.25 m sizes, suitable for large volume and high viscosity delivery through thinner needles. Safelia® can mechanically “tune” the injection thanks to design adjustments.
It has been designed to ease patients’ self-injection experience and to deliver the most challenging drugs, in subcutaneous or intramuscular layers.

Key benefits of Safelia®

Patient friendly

• No initial injection peak
• Constant delivery flow
• Adjustable needle insertion speed
• Needle insertion disconnected from injection
• Automatic needle retraction
• Possibility to have thinner needles

Syringe friendly

• Syringe is held encapsulated through the barrel
• Syringe front housing
• No stress on the syringe flange
• Possibility to inject very viscous drugs

To win an INTERPHEX Exhibitor Award, the exhibit/booth must excel in each criterion, rise above competitors, and clearly reflect excellence in pharma and biopharma development and manufacturing.

The judges evaluated each submitting exhibitors booth based on the following criteria:

• Overall Appeal/Experience (Design)
• Knowledge (Content)
• Product/Service Innovation
• New Technologies or Novel Implementation of Existing Technologies
• Advances in Features and Performance
• Development of Novel Technologies
• Novel Implementation of Existing Technologies
• Advances in Services Provision
• Significant New Services Additions
• Showcasing of Technical Knowledge

The judges on this year’s Exhibitor Awards panel were:

• Meg Snyder, Editor at Pharmaceutical Processing
• David Hall, Vice President of Sales at Parenteral Drug Association (PDA)
• Barry Holtz, Principal at Holtz Biopharma Consulting
• Eric Jayjock, PhD, Director of Continuous Manufacturing at Patheon
• Christa Myers, Associate, Lead Process Engineer at CRB
• Gil Roth, Founder and President of the Pharma & Biopharma Outsourcing Association
• Matthew VonEsch, Senior Director Manufacturing at Exelead

Allergan selects Aptar Pharma for Restasis Multidose™

Sans titre

Aptar Pharma’s innovative and patented preservative-free multidose Ophthalmic Squeeze Dispenser is available for patients in the U.S. prescription market for the first time with Allergan’s RESTASIS MULTIDOSE™ (Cyclosporine Ophthalmic Emulsion) 0.05%.

This approval and launch makes the Aptar Pharma Ophthalmic Squeeze Dispenser the very first, and only, U.S. FDA-approved multidose delivery system to handle prescription eye treatment formulations without any preservatives.

 
Picture – Courtesy of Allergan Inc.

Meeting the needs of patients

Aptar Pharma is working closely with eye care specialist Allergan to improve patient safety, achieve dosing accuracy and maintain product integrity.
Dry eye patients use eye drops on a regular basis, and often for the rest of their lives. It is well-proven that preserved medications may cause unpleasant and sometimes serious side effects.

FDA approval

The increasing number of patients experiencing eye irritation or allergic reactions with preserved formulations appreciate the fact that preservatives can be removed from eye care medications with Aptar Pharma’s Ophthalmic Squeeze Dispenser system. RESTASIS® and RESTASIS MULTIDOSE™ are FDA-approved prescription treatments to help patients suffering from Chronic Dry Eye to make more of their own tears.

Making ophthalmic solutions easier and safer to deliver

Aptar Pharma’s Ophthalmic Squeeze Dispenser system is the result of more than 10 years of development and experience in the delivery of preservative-free ophthalmic solutions. Patients and consumers in Europe, Latin America and Asia have benefited from this technology since 2012 with more than 100 commercial references now available on the market.
RESTASIS® is not an artificial tear. It is a prescription medicine that helps increase the eyes’ natural ability to produce tears.
“Our Ophthalmic Squeeze Dispenser technology has been a great success for our customers,” explained Salim Haffar, President, Aptar Pharma. “The proven and unrivalled microbiological safety, combined with a precise and reproducible drop ejection allows pharmaceutical customers worldwide to enter into discussions with regulatory agencies such as the FDA.” Mr. Haffar also points out the user-friendliness of the system, “The ergonomic and pocket-size design and the intuitiveness of a squeezable container with a low actuation force certainly contribute to the high levels of acceptance among patients and consumers around the world.”

Biogaran takes over Swipha’s activities in Nigeria to produce generic drugs for the local market

Lagos, Largest City in Africa

 

In order to develop new markets to meet its commitment to provide all patients with quality medication, Biogaran, a pioneer in generics and a subsidiary of Servier, has just taken over Swipha, a Nigerian pharmaceutical company that produces generics to meet local health needs. Its portfolio is mainly focused on three families of products which treat Nigeria’s most widespread infections and health issues: antimalarial drugs and antibiotics, anti-anxiety and tranquillizers.

Lagos, Largest City in Africa

Nigeria is the largest economy in Africa and its most populated country (184 million inhabitants in 2016 according to the IMF).

Swipha was the first Nigerian pharmaceutical company to obtain ISO 9001 certification in 2007. Approved by the World Health Organization (WHO) in 2014, Swipha employs 300 people locally and generated record sales of NGN 4bn (approximately € 20 million) in 2012. Beyond its production unit, the company also has a wide distribution network covering most parts of Nigeria.

Health issues are particularly important in Africa. Beyond significant needs for good quality, inexpensive and effective medicines, the problem of counterfeits is also becoming of concern. The WHO estimates that 100,000 deaths are due to fake medicines in Africa every year[1]. In this context, supplying Nigeria’s population with reliable medicines that are produced locally is a strong commitment made by Biogaran.

“Biogaran’s international expansion strategy is to create synergies by bringing its expertise and investment capacity in production to existing structures”, commented Pascal Brière, President of Biogaran. “Nigeria quickly came out as the best entry point on the African continent with its strong population and solid economic fundamentals, including a very dynamic market economy; Swipha’s know-how, reputation and network have immediately convinced us that it was the right partner for us.”

Lilly Announces $850 Million Investment in U.S.

Lilly headquarters

Lilly has announced this month plans to invest $850 million in its U.S. operations in 2017. The company’s investments span facilities across its U.S. enterprise, including research laboratories, manufacturing sites, and general and administrative areas. The investments are being driven by demand for Lilly products, as well as its robust pipeline of potential medicines in development targeting cancer, pain,
diabetes and other unmet medical needs.

Company leaders were joined by federal, state and local government officials at Lilly Technology Center, where the details of the investments were unveiled, including plans for a new $85 million expansion of its Trulicity® (dulaglutide) device assembly operations in the U.S. This expansion is part of a massive five-year investment by the company to expand its diabetes products manufacturing operations in the U.S., which also includes a $140 million insulin cartridge production
facility that was officially dedicated at today’s announcement.

David A. Ricks, Lilly’s president and chief executive officer, said that Lilly’s potential for growth and its long-standing commitment to the U.S. market led to its decision to invest in its U.S. operations and expand its manufacturing footprint in Indianapolis.

“Our future at Lilly is bright, as we’re on a path to launch 20 new products in a 10-year time frame,” Ricks said. “As we have for our entire 140-year history, we continue to see Indiana and the United States as attractive places to research and make the medicines that we sell around the world.”

Ricks explained that Lilly’s $850 million investment will fund both projects that are already underway as well as new projects that will be initiated throughout the course of the year, including additional projects in Indianapolis.

Diabetes products manufacturing investment

Company officials focused much of today’s announcement around its massive investment in diabetes products manufacturing. Over the course of the last five years (2012-2016), Lilly has invested approximately $1.1 billion to boost its diabetes products manufacturing operations in the U.S. These investments include upgrades to existing facilities, as well as the addition of new capacity and capabilities based on the evolution of the company’s diabetes pipeline and portfolio and
the increased prevalence of the disease.

During this period, Lilly has increased its U.S manufacturing workforce by more than 1,000 employees—from 5,000 to 6,000 roles—with approximately 400 added in Indianapolis.

“More than 400 million people around the world have diabetes—and that includes approximately 30 million people in the U.S. alone,” said Enrique Conterno, president, Lilly Diabetes and Lilly USA. “Lilly has spent more than 90 years providing solutions to people with diabetes, and today’s announcement extends the deep commitment of our heritage. This manufacturing expansion, along with the introduction of several other new treatments over the last two and a half years, will allow Lilly to continue to be a leader in diabetes care.”

Conterno added that the new investments underscore Lilly’s diabetes manufacturing presence in Indianapolis. Lilly’s stateof-the-art manufacturing facility in Indianapolis is part of the company’s nine-decade legacy of producing insulin.

“In addition to providing the capacity necessary for the safe and reliable supply of medicines to patients, these investments have allowed us to add U.S. manufacturing jobs,” said Maria Crowe, president of Lilly Manufacturing. “These include highlyskilled technicians, scientists and engineers, which are an economic catalyst for local communities.”

Further, Crowe noted that during the past five years, construction-trade staffing has averaged nearly 500 jobs, and had a peak level of nearly 1,000 workers. The ongoing operations together with the investment programs will continue to require a significant level of construction-trade workers at the Lilly Technology Center.

“Lilly’s announcement today is a clear example of what a fiscally sound state with a strong business climate—coupled with a world-class company—can achieve,” said Indiana Gov. Eric J. Holcomb. “I am grateful for Lilly’s continued investment in Hoosiers and in our home state, and will work to maintain the strength of the life-sciences industry and advanced manufacturing in Indiana.”

“Despite a global presence and diverse interests, Lilly’s continued investment in Indianapolis is a testament to their exceptional level of faith in our workforce and a decades-long commitment to this community,” said Indianapolis Mayor Joe Hogsett. “As the biotech industry continues to grow in Indianapolis, Lilly remains a clear leader, bringing advancements to the field and high paying jobs to the city. I’m excited for what today’s announcement means for the company’s future and
look forward to Lily’s continued advancements as their footprint in our city grows.”

Ricks concluded by saying that Lilly has invested approximately $5 billion in its U.S. facilities during the last decade and that more investments can be expected, particularly if the U.S. adopts a more favorable tax environment.

“The equitable treatment of foreign earnings, a lower U.S. corporate tax rate, and U.S. innovation incentives—similar to the rest of the world—will encourage significant investment in the U.S., creating economic growth and good jobs for Americans,” said Ricks. “The House Republican Blueprint with border adjustability is designed to achieve these priorities, puts America’s global companies on a level playing field with competitors around the world, and creates economic growth and employment
within the U.S.”