Catalent Expands Kansas City Clinical Storage & Secondary Packaging Capabilities To Meet Growing Demand For Cold Chain Services

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Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, announced that it had completed an expansion project at its Kansas City, Missouri, facility to significantly increase controlled-temperature storage capabilities for its clinical supply business.

The expansion has added 70,000 cubic feet of storage (2-8 degrees Celsius) at the site, representing a five-fold increase in controlled-temperature capacity. This is made up of a combination of both pallet and high density storage options to increase flexibility. In order to support growing customer demand, two secondary cold packaging areas have been added, with the option to add more as needed.

“Customers have benefitted from our Kansas City campus’ integrated analytical, oral solid manufacturing, and clinical supply services, and now we can offer them expanded cold storage and packaging services as well,” commented Tom Moon, General Manager of Clinical Supply Services at the site. “In the past 18 months, we seen an increase in the numbers of both large and small customers, and to meet this growing demand have nearly doubled our clinical supply workforce, as well as introducing additional shifts in both packaging and distribution.”

Catalent’s 450,000 square feet Kansas City facility provides a range of fully integrated support services, from development and analytical support through to packaging and distribution. In 2015, the site completed an investment project that expanded its high-potent and cytotoxic clinical drug packaging capabilities.

Catalent has also recently announced investment and expansions to its workforce in its clinical supply network at Bolton and Bathgate in the U.K., and in Singapore.

Sanner passes 60 million Euro mark in 2016

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“Once again, 2016 was a very successful year for Sanner. Compared to the previous year, we were able to increase our total turnover by 6.9 percent,” says Dirk Mähr, Managing Director of Sanner GmbH. “This continuous growth, as well as the numerous developments and investments show that we are well prepared for the future”, says Ralf Tiemann, Managing Director Sanner Kunshan China.

Investments included an exchange of most machines for Sanner products in Bensheim, Germany. “The increase in automation and the acquisition of new production machines contribute to an increase in capacity and efficiency,” says Mähr. In the coming years, Sanner will consistently expand its portfolio for capsules and desiccant packaging.

 

The company has also strengthened the range of services and developments of customer-specific products with the Sanner Atmo Guard System® and the IDP-Process®, which was recently introduced at Pharmapack Europe. The IDP-Process® meets the growing need for customized, holistic packaging concepts for pharmaceuticals and medical devices. Customers receive individual packaging solutions with a design that not only meets the highest requirements, but which is also suited for large-scale serial production, while fulfilling all technical and regulatory demands.

The expansion of the cleanroom capacities in Kunshan, China, focused on efficiency and product safety. Since February 2017, 200 additional square meters of production space are available at the site. However, Sanner does not rest on its laurels: “The past years’ successful business results and our excellent future prospects in Asia will require continuous capacity expansions over the coming years,” says Ralf Tiemann. Upon completion of the second construction phase at the end of the first half-year, the company will be able to produce in 2,700 square meters of cleanroom space.

A great deal has also happened at the production site in Hungary: on one hand, new employees could be recruited to strengthen the team. On the other hand, the sites in Bensheim and Budapest are cooperating more closely to establish a broader platform for future growth projects in Europe. “With these numerous portfolio and capacity expansions, we are sustainably investing in the future of our production sites”, Dirk Mähr summarizes. “This way, Sanner is well positioned for further growth.”

Aptar Pharma is delighted to welcome delegates to RDD Europe 2017, which they’ve co-organized with RDD Online since 2005.

Photo Courtesy of Aptar Pharma

In addition to the high-quality scientific program at RDD Europe, Aptar Pharma will be hosting a joint workshop with Propeller Health on Wednesday, April 26. Entitled “Using Connected pMDIs to Monitor Inhaler Use and Drive Better Quality of Care,” they will discuss the findings of recently conducted user studies with their integrated connected pMDI. Three 60-minute interactive workshops will be held from 2:00-6:00 pm.

 

Photo Courtesy of Aptar Pharma

During the conference, stop by Exhibit Table #25 and experience first-hand why Aptar Pharma is your trusted partner in connected health. Speak to their experts and discover Aptar Pharma’s proprietary portfolio of electronic and connected inhaler devices, moving from drug delivery devices to improved healthcare outcomes. Demonstrations of their technology will be available subject to schedule availability.

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

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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

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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

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New award for Nemera with Safelia®

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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™

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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.”

DropAid for easy use of eye droppers

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People who use eye drops know how difficult they are to put in safely without assistance. Sometimes the small sized eye drop bottles can also be difficult to open. Gerresheimer’s packaging experts have developed an application aid called DropAid to eliminate this problem. DropAid is an application aid for daily use. It helps dropper bottle users to open the bottle and, when placed on the bottle neck, it makes it easy and simple to positioning the dropper correctly above the eye.

“We put ourselves in the shoes of the person who has to use the eye drops and considered how we could make it easier to use. That’s how we came up with this small but extremely useful DropAid that we’d like to recommend to all our customers who manufacture eye drops. It will also help them to ensure better compliance in the medications,” said Niels Düring, Global Senior Vice President Plastic Packaging at Gerresheimer.
DropAid is incredibly easy to use, so it’s ideal for senior patients and children. It has a circular aperture which fits perfectly onto the eye drop bottle top and helps to open it with very little effort or pressure. If DropAid is placed vertically on the bottle neck with the crescent part clipped onto the open bottle, it can be rested firmly on the side of the eye so that the correct number of drops can be given.
DropAid fits “System A Dropper Bottles” for ophthalmic applications. Gerresheimer’s products for ophthalmic and nasal applications include LDPE, HDPE, PP and other materials for bottles and droppers and CLC bottles. For ophthalmic Gerresheimer also produces lens cases, bottles for nasal sprays with nebulizer or pump systems. Further materials, sizes and designs are also available, and the range includes child-resistant and senior-friendly closures.

Gerresheimer adapts its eye drop bottle to new FDA requirements

Gerresheimer is one of the world’s leading suppliers of plastic eye drop bottles. It recently modified the closure system on its Type A dropper bottle to the FDA’s new requirements. Now the tamper evident ring stays firmly affixed to bottle once it has been opened.
The tamper evident ring is important because it tells the user that the product hasn’t been opened since filling. This guarantees that the bottle contains the original pharmaceutical and that nobody else has previously opened or used it. Although that’s important with all medications, it’s particularly important with eye drops, which shouldn’t be administered if they are contaminated. “Sometimes it’s the little ideas that make a big improvement to a product,” said Marek Misczcak, Head of Research & Development at Gerresheimer and primary packaging expert for ophthalmic applications. “Before the modification, the tamper evident rings were loose on the bottle neck after opening. Unless the user removed the ring, it constituted a potential hazard. That’s why fixing the tamper evident ring in place is a good idea that improves safety.” None of the other eye drop bottle specifications have changed.

Two Leaders of the « Auvergne – Rhone – Alpes » Pharmaceutical community share their expertise

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The contract manufacturer Excelvision, in partnership with Laboratoires Thea, inaugurate their new sterile manufacturing facility on 26 January 2017 : 4000m2, two production lines and the infrastructure for 5 lines in the future.

Excelvision installed on the Lombardière Industrial zone in Annonay (Ardèche), is an affiliate of the Fareva Group, the lead Pharmaceutical CMO in Europe.

Laboratoires Thea based in Clermont Ferrand (Puy de Dôme) is the third largest European Ophthalmic specialist.

The two new BFS (Blow Fill Seal) lines allow Excelvision to push their capacity for the production of preservative free eye drops in single dose units from 500 to 800 million vials per year.
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This investment will allow Excelvision to accompany Laboratoires Thea for the manufacture under aseptic conditions of their “Latanaprost” eye-drop developed for the treatment of glaucoma.
A Pharmaceutical Laboratory and a CMO – both French, both family owned organisations, both internationally renowned – joined in partnership to ensure the development of their companies with the construction of a new manufacturing facility for an investment of 28M€ leading to the future recruitment of 90 employees.

By meeting the high level requirements of the Pharmaceutical Industry while significantly increasing production capacity, by recruiting locally with specifically developed training programs, Thea and Excelvision actively participate in the development of industry in France, its presence throughout the world and the defense of employment.

Sanner IDP-Process®: tailor-made packaging in six steps

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Inhalers with special geometry, a new type of child-resistant closures, or a breakage-proof dual-chamber syringe? No matter how challenging the project is, Sanner’s IDP-Process® provides customers with individual packaging solutions and manages their requests from the first idea right through to serial production. The smart, efficient and safe IDP-Process® meets even the most challenging drug packaging requirements.

IDP stands for ‘Idea. Design. Product.’ and consists of a six-phase development process that has only one goal: an individual, high-quality packaging solution.

In the concept phase, the Sanner specialists develop different approaches based on customer demands and regulatory requirements, whilst already taking into account the criteria for subsequent serial production. Once the customer has chosen his favorite solutions, the concepts are further specified in the design phase, followed by qualification and testing of required equipment and product samples during the prototype phase.

The industrialization phase consists of the final manufacture, installation and qualification of production equipment, as well as the definition of parameters for a smooth and efficient production process. This process is validated in the implementation phase, while all documents required for approval and registration of both drugs and packaging are issued simultaneously. While the customer starts rolling-out his product, Sanner makes sure that consistently high product quality is maintained in serial production.

After the market launch, Sanner further supports customers with dedicated services over the entire product life cycle. To this end, a high priority is on strictly GMP-compliant manufacturing and 100 percent traceability.