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.

Sanofi and Lonza Enter into a Strategic Partnership to Establish a Large-Scale Biologics Production Facility

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Sanofi and Lonza have announced that they have entered into a strategic partnership to build and operate a large-scale mammalian cell culture facility for monoclonal antibody production in Visp, Switzerland. The strategic partnership in the form of a joint venture combines the strong biologics development pipeline of Sanofi with the expertise of Lonza to design, construct, start-up and operate a state-of-the-art large-scale mammalian cell culture facility. The initial investment will be around CHF 290 million (€ 270 million), to be split equally between each company.

The initial phase of the facility will commence construction in 2017, pending necessary regulatory approvals, and is expected to be fully operational by 2020. Lonza has previously built and licensed three similar facilities in the U.S. and Singapore.

“In addition to the investments we are making in building our own internal production capabilities, the joint venture between Sanofi and Lonza emphasizes our commitment to provide access for patients to high quality therapeutic monoclonal antibodies,” said Philippe Luscan, Executive Vice President, Global Industrial Affairs, Sanofi. “Approximately sixty percent of our pipeline is made up of biologics, including monoclonal antibodies, dedicated to key disease areas such as cardiovascular, immunology and inflammation, neurology and oncology. Lonza is a highly experienced partner in this field and the capabilities which this joint venture will create are critical to meeting our patients’ needs for these important therapies.”

“By entering into this long-term strategic relationship we have developed a tailor-made business model that best fits both Sanofi’s and Lonza’s requirements. It provides to Sanofi dedicated capacity, which allows for a clear win-win situation for all participants,” said Marc Funk, COO Pharma & Biotech, Lonza. “As part of our strategic roadmap, we will develop further innovative business models based on the requirements of our customers. We intend to address these long-term market needs by establishing a state-of-the-art strategic biologics manufacturing platform. The strategic partnership with Sanofi represents the first module in this undertaking; and we are convinced that with this future-oriented approach, we can serve additional customers.”

The partnership provides both Sanofi and Lonza with substantial flexibility in an innovative setup:

  • Each party will share the available capacity in line with their equity shareholding in the joint venture
  • Sanofi will have additional access to bio-manufacturing capacity to support increasing demands for their portfolio of biologic therapeutic products, should they require it
  • Lonza will be free to market their share of capacity, if not required by Sanofi, and will also market unused Sanofi capacity, where available.
  • Lonza will construct the facility and will support the joint venture in its operation of the facility.

The strategic partnership enables Sanofi to react quickly to fluctuations in demand in a short timeframe, reinforcing their capability to launch high-quality, next generation biologic medicines and ensure consistent access for patients. It also provides Lonza with needed capacities to respond to growing manufacturing demands for large-scale mammalian cell culture based therapeutic proteins, therefore allowing Lonza to better serve its customers. By adding flexibility in this way, this model will help to optimize biologics production capacity across the whole industry.

Spider web of cancer proteins reveals new drug possibilities

Senior author Haian Fu, PhD

Scientists at Winship Cancer Institute of Emory University have mapped a vast spider web of interactions between proteins in lung cancer cells, as part of an effort to reach what was considered “undruggable.”

This approach revealed new ways to target cells carrying mutations in cancer-causing genes. As an example, researchers showed sensitivity to an FDA-approved drug, palbociclib, for a gene that is commonly mutated in lung cancer cells, which is now being tested in a clinical study.

 

Senior author Haian Fu, PhD

Many genes that drive the growth of cancer cells don’t have any drugs available against them. For “tumor suppressor” genes, researchers are often not sure how to go after them. When the tumor suppressors are gone, cells often become more deranged, but there’s no bullseye left to target. Exploiting the cancer cells’ derangement remains a daunting challenge, says senior author Haian Fu, PhD.

“Our approach is to place tumor suppressors in the context of a network of cancer-associated proteins and link tumor suppressors to drugs through a known drug target protein” Fu says. “In this way, changes in a tumor suppressor may be linked with the response of the target to the connected drug.”

The study is part of a push by the National Cancer Institute’s Cancer Target Discovery and Development (CTD2) network to translate genomics data into therapeutic strategies, he says. Emory is a member of the NCI CTD2 network.

Fu holds the Winship Partner in Research endowed chair and is leader of Winship’s Discovery and Developmental Therapeutics Program, director of the Emory Chemical Biology Discovery Center and professor of pharmacology and hematology and medical oncology. Co-corresponding author Fadlo Khuri, MD, maintains his professor appointment at Winship Cancer Institute and is now president of the American University of Beirut in Lebanon.

Cancer researchers have been searching for ways to target mutations in the gene STK11/LKB1, found in 15 to 25 percent of non-small cell lung cancers. The tumor suppressor STK11/LKB11 encodes an enzyme that is thought to regulate cell migration and metabolism.

One of the Winship team’s newly identified interactions — a “thread” in the spider web — suggested that palbociclib, recently approved against metastatic breast cancer, may work against cells carrying mutations in LKB1, through LKB1’s connection to CDK4, the target of palbociclib.

That prediction was supported by genomic data analysis and cell culture experiments: lung cancer cells with LKB1 defects showed a tendency of increased sensitivity to palbociclib. Now a study led by Taofeek Owonikoko, MD, at Winship is using LKB1 status as a biomarker for interpreting the effect of palbociclib.

How OncoPPI works

If cells are complex machines, then a number of ways exist for figuring out how the machines’ parts, dominated by proteins, fit together. Some of them involve multiple washing steps to remove nonspecific partners after breaking cells apart, but FRET (Förster resonance energy transfer) does not. If two fluorescent molecules with colors that are near on the spectrum are close enough (less than 10 nanometers), that proximity can be detected by FRET.

Fu and his colleagues established a large-scale platform for tagging proteins with two different fluorescent molecules, introducing them into cancer cells, and then detecting interactions between the proteins. They call this network of cancer-associated proteins “OncoPPI.”

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Starting witha set of 83 lung cancer-related proteins, the team detected more than 260 interactions that were not known previously. They tested the interactions several times, in different orientations, and in other lung cancer cell lines with selected interactions to establish reliability. More than 80 percent of the interactions the researchers detected could be confirmed by another method (GST pulldown).

As an additional example to illustrate the utility of a protein interaction web, the team focused on the prominent oncoprotein Myc, which was also considered “undruggable.” But the researchers could connect Myc indirectly through NSD3 to another protein called Brd4, against which inhibitors have been developed. Brd4 inhibitors are being currently tested in clinical trials. This finding revealed a new pathway Brd4-NSD3-Myc as potential targets for therapeutic intervention, Fu says.

The OncoPPI research was supported by the National Cancer Institute Cancer Target Discovery and Development network, lung cancer program project and Winship Cancer Institute and the Georgia Research Alliance, and the Emory University Research Committee. The clinical study of palbociclib is sponsored by Pfizer.