Gerresheimer: Highest Quality Vials

gerresheimerfocuson

Gerresheimer has set up an investment program spanning several years to install state of-the-art converting machines for vial manufacturing at all its plants. The latest-generation machines and global high standards will enable us to meet even more stringent future requirements of product quality. The aim of this project is absolutely clear: We want to supply our customers with significantly improved vials in the highest possible quality. The latest generation of machines, monitoring and inspection systems guarantees the same high Gerresheimer quality standards at every single one of our tubular glass converting plants around the world.

Sanner launches new senior-friendly FOG 27 closure

sanner

The new FOG 27 closure for effervescent tablets from Sanner is easier and faster to open compared to conventional closures – not only for best-agers.

About a quarter of adults consume nutritional supplements such as vitamins or minerals, often sold as effervescent tablets. About half of these consumers are 60 years or older; so-called best-agers. Subsequently, good and easy handling of the packaging is especially important. “For producers of food supplements this is a decisive factor,” says Ursula Hahn, product manager at Sanner. “In case of bad experiences with the packaging, repurchase rates decline considerably.”

To find a remedy, Sanner has developed the new, user-friendly FOG 27 closure – and let consumers judge in a comprehensive study. The most striking result of the test is that 87 percent of the participants confirmed the intuitive opening. Apart from the easy removal of the warranty band, testers particularly appreciated the painless, single-handed opening. They neither complained about pressure marks on their thumb, nor about aching fingers. As far as opening time is concerned, the new FOG 27 also stands out from conventional closures: participants required approximately a third of the time to open the FOG 27 (9.2 instead of 25.8 seconds). Moreover, the amount of physical effort needed for the first opening is significantly lower: 12 newton instead of 36 newton.

In terms of tightness, the FOG 27 is just as reliable as conventional closures: despite the easy opening, full product protection is ensured. “One of the reasons,” Ursula Hahn explains, „is that the FlipTop of the new closure is tightly attached to the tube and can be intuitively closed.” Another advantage: the closure cannot get lost. This way, a small packaging optimization provides significantly higher convenience and customer satisfaction. Thanks to the good handling, around 90 percent of best-agers would buy the product with the user-friendly FOG 27 closure again.

New ISO7 Clean room for Union Plastic

union

UNION PLASTIC, located in Saint Didier in Velay (43), global expert from the design to the manufacturing of plastic parts for the healthcare industries, has built to support its business growth a new ISO7 clean room of 50 m2.

This new clean room equips the MUP factory of the company dedicated to the diagnosis, medical and pharmaceutical
markets. It will integrate a production of 5 and 10 ml Luer lock injectable syringe and consumable for immuno diagnosis. From the customer specifications, our technical department identifies the production environment the most adapted by adapting the zone to the products and not by trying to fill existing premises. UNION PLASTIC qualifies and manages all of its manufacturing environments (ISO7, ISO8 and ISO9 classes) to take forward the products security avoiding additional costs due to an environmental exaggeration. With this new equipment, UNION PLASTIC maintains its position as a key actor of the injection molding under controlled environment with more than 1,5 billion parts produced each year worldwide.

RayDyLyo The Vial capping solution for aseptic filling

araymondlife

ARaymondlife chose to collaborate with Disposable Lab (a company specialising in single use production equipment) in order to offer a complete solution for aseptic filling in an isolator.

RayDyLyo is an innovative, ready-to-use, fully plastic capping solution.  RayDyLyo can be used for injectables for both liquid and lyophilised forms, and is available in 13mm and 20mm diameters.  The pre-assembly of the stopper in the RayDyLyo facilitates the correct sealing and capping of the vial in a single operation. RayDyLyo can be used in closed system, isolators or RABS, for both manual and automatic closure of ISO vials.  It is also suitable for the automated closure of vials in nests.

ARaymondlife chose to collaborate with Disposable Lab (an independent French company specialising in single use production equipment) in order to be able to offer a complete solution for aseptic filling in an isolator.

Disposable Lab is presenting the market with an innovative concept – Pyrofree, sterile, ready to use depyrogenated glass vials along with a compact isolator (certified sterile environment) which can be reproduced at an industrial scale.

This single use isolator allows between 1000 and 1500 vials to be filled daily.  With RayDyLyo the environmental integrity is maintained, because the RayDyLyo ready-to-use solution combines the sealing and capping operations – and thereby eliminates the separate aluminium capping operation – so also eliminating the risk of aluminium particulate contamination.

This combination of ready-to-use solutions revolutionises the traditional process of filling and closing vials. Thanks to this marriage of expertise, ARaymondlife and Disposable Lab can offer a complete, rapid, simple and economical service to optimise the production of technical, clinical or feasibility batches.

At the end of the year ARaymondlife is holding a training day in the use of the RayDyLyo in an isolator.

This event organised in association with Disposable Lab will be held at the premises of ACCINOV, the GMP bio-manufacturing centre dedicated to the development of experimental drugs and medical devices emanating from Lyonbiopole (the health biocluster of the Auvergne-Rhone-Alpes region).

The objective of this educational event is to give the attendees an opportunity to try their hand at closing Pyrofree vials with the RayDyLyo cap in the Disposable Lab single use isolator, to convince themselves of the advantages of this innovative system

 

Clariant Healthcare Packaging Expands BCP Program with Desiccants from Chinese Site

clariant news

Clariant, a world leader in specialty chemicals, and its Healthcare Packaging unit, is launching family of standard desiccant packets from its plant in Dongguan, China. In addition to enabling quick delivery in local markets, the new manufacturing operation can provide critical back up for Clariant’s other global sites, should it ever be required.

“Business Continuity Planning or BCP is critical to our pharmaceutical stakeholders who are more and more requiring that we have strong contingencies,” says Matthias Brommer, Vice President and Head of Clariant Healthcare Packaging. “Accordingly, we are developing a global infrastructure that ensures that we are prepared to deal with any market or operational disruptions.”

The Donguan plant applies the same specifications, quality standards, good manufacturing practices and controls as Clariant’s other global production sites in Belen, New Mexico, USA, and Romorantin, France. Compliance protocol is also the same, and pharmaceutical desiccants produced in Dongguan comply with US FDA and EU standards for contact with food.

In Dongguan, Clariant will produce its global desiccant brands Sorb-it® (silica gel) and Tri-Sorb® (molecular sieve) desiccant packets, and include Tyvek® and Continu-Strip® hole punch packets that feature a hole in every seal to optimize the desiccant insertion process.

The network of production sites will soon include a fifth facility in Cuddalore, India, where Clariant recently broke ground. Also integral for BCP, the new plant in Cuddalore will supply the large and growing Indian market, the largest producer of generic drugs globally.

“The trend in this market is to require BCP,” says Brommer, “Clariant’s extensive global footprint both enables production of identical products at multiple sites while enhancing our service to our global customers.”

LYOCONTRACT your partner for contract manufacturing in vials

Lyocontract

LYOCONTRACT GmbH started manufacturing in 2012 after receiving its manufacturing license according to § 13 of the German Drug Law (AMG) and GMP certification. The core business is the development and GMP conform manufacture of liquid and freeze-dried drugs in vials according to customers’ orders. We expanded our production capacity with a second freeze-dryer that is available now.

 

Metsä Board’s new folding boxboard machine at husum mill inaugurated

metsa

In April, Metsä Board, part of the Metsä Group, had its new folding boxboard machine at Husum in Sweden inaugurated. After considerable structural changes Husum mill is now an integrated site concentrating on paperboard and pulp manufacturing. It is also a significant local employer. The EUR 170 million investment programme included a folding boxboard machine BM1 supplied by Valmet as well as enhancements to the pulp mill and the mill site’s own port. The capacity of the new machine is 400,000 t/a.

“The Husum mill site has the best available technology, people with extensive know-how and access to an ideal location by the sea where the mill has its own port. These important success factors will also support our customers in their businesses,” says Mika Joukio, CEO of Metsä Board.

FDA Approves First And Only Single Monthly Injection For A PCSK9 Inhibitor

medic

Amgen has announced that the U.S. Food and Drug Administration (FDA) has approved the Repatha® Pushtronex™ system (on-body infusor with prefilled cartridge), a new, monthly single-dose administration option. The Pushtronex system is a hands-free device designed to provide 420 mg of Repatha in a single dose. Repatha is the first and only PCSK9 inhibitor to offer a monthly single-dose delivery option (Repatha® Pushtronex™ System Available to U.S. Patients in Early August)

“The Pushtronex system exemplifies Amgen’s continued innovation and commitment to patients,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Repatha is the only PCSK9 inhibitor with an approved monthly dose, and now the only one with a monthly single-dose administration. The FDA approval of the Pushtronex system offers another delivery option to patients who need the additional LDL cholesterol lowering that Repatha can provide.”

The new, single-use device was developed in collaboration with West Pharmaceutical Services, based on the SmartDose® technology platform, to provide patients with an additional dosing option for Repatha treatment. The device adheres to the body and patients are hands free during administration. Patients are able to perform moderate physical activities (such as walking, reaching or bending) as the 420 mg of Repatha is delivered subcutaneously.

Bristol-Myers Squibb Acquires Cormorant Pharmaceuticals

BMS

Bristol-Myers Squibb and Cormorant Pharmaceuticals have announced that Bristol-Myers Squibb has acquired all of the outstanding capital stock of Cormorant, a private, Stockholm, Sweden-based pharmaceutical company focused on the development of therapies for cancer and rare diseases. The acquisition gives BMS full rights to Cormorant’s HuMax-IL8 antibody program and the lead candidate HuMax-IL8, a Phase 1/2 monoclonal antibody targeted against interleukin-8 (IL-8) that represents a potentially complementary immuno-oncology mechanism of action to T-cell directed antibodies and co-stimulatory molecules.

IL-8 is a protein expressed by many solid tumors within the tumor microenvironment that suppresses the immune system and increases the ability of tumors to metastasize. By targeting IL-8, HuMax-IL8 offers the potential to enhance immune response and increase the efficacy of existing cancer medicines through combination therapy. The rights to HuMax-IL8 were acquired by Cormorant from Genmab A/S in 2012 under an exclusive license agreement.

“We believe combination therapy will be foundational to delivering the potential for long-term survival for patients, and the opportunity to develop the HuMax-IL8 antibody program together with our broad Immuno-Oncology pipeline enables us to accelerate the next wave of potentially transformational immunotherapies,” said Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer, Bristol-Myers Squibb.

“BMS is the ideal company to maximize the potential of both Cormorant and the HuMax-IL8 program, and bring hope to more patients,” said Maarten de Château, M.D., Ph.D., chief executive officer, Cormorant Pharmaceuticals. “BMS is the leader in the Immuno-Oncology field, with deep clinical development and regulatory expertise, and an established commercial infrastructure to deliver important new therapies to patients quickly. Bristol-Myers Squib’s rich pipeline of clinical candidates and approved products provides even more opportunity for potential therapeutic synergy when coupled with HuMax-IL8.”

The transaction includes upfront and near term contingent milestone payments of up to US $95 million and additional contingent consideration of up to US $425 million upon the achievement by BMS certain development and regulatory milestones.

Four NCI Cancer Centers Announce Landmark Research Consortium and Collaborations with Celgene

Laboratory research of cancer diseases,  rack with RNA samples

The Abramson Cancer Center at the University of Pennsylvania, The Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, and The Tisch Cancer Institute at the Icahn School of Medicine at Mount Sinai announced the establishment of a research consortium focused on accelerating the discovery and development of novel cancer therapeutics and diagnostics for the benefit of patients.

The consortium aligns four major academic institutions in a unified partnership with the shared goal of creating high-impact research programs to discover new treatments for cancer. The magnitude of the multi-institutional consortium and agreements between Celgene Corporation and each institution will support the rapid delivery of disease-altering programs to the clinic that may ultimately benefit cancer patients, global healthcare systems and society.

Subsequent to establishing the consortium, Celgene entered into four public-private collaboration agreements in which it paid a total of $50 million, $12.5 million to each institution, for the option to enter into future agreements to develop and commercialize novel cancer therapeutics arising from the consortium’s efforts. Over the next ten years the institutions intend to present multiple high-impact research programs to Celgene with the goal of developing new life-saving therapeutics. Subject to Celgene’s decision to opt-in and license the resulting technologies, each program has the potential to be valued at hundreds of millions of dollars.