Araymondlife: A flexible solution for aseptic filling

araymondlife

Accinov, ARaymondlife & Disposable Lab have combined their know-how to offer a Fill & Finish solution for biological drugs.

Disposable Lab offers a solution consisting of a single-use isolator and Pyrofree® RTU glass vials together with the RayDyLyo® plastic push fit caps from ARaymondlife. It constitutes the 1st single-use aseptic filling line allowing Accinov to propose the F&F of small batches.

Visit Araymondlife’s booth

MilliporeSigma Opens Production Facility Exclusively for Meglumine in Spain

MilliporeSigma

MilliporeSigma opens a facility in Mollet des Vallès, Spain dedicated to the manufacture of meglumine, an FDA-approved excipient for pharmaceuticals and a component of medical imaging contrast media.

The facility, validated by the FDA, is the only location in Europe that manufacturesmeglumine, an amino sugar derived from glucose. The facility in Spain is solely dedicated to the production of meglumine, thereby ensuring continuity of supply to customers as well as meeting increasing demand for the excipient. As an excipient, meglumine interacts directly with active pharmaceutical ingredients to increase solubility. Therefore, the manufacture of meglumine must meet the same stringent regulatory and quality requirements as APIs. “Our new facility was optimized around the manufacturing process to achieve greater efficiencies and meets the most stringent quality standards for manufacturing meglumine,” said Andrew Bulpin, Head of Process Solutions Strategic Marketing & Innovation, MilliporeSigma. “The result is a high level of confidence in quality and security of supply for our customers.”

Lilly enhances its existing pain management portfolio for migraine with CoLucid Pharmaceuticals acquisition

Lilly

Lilly and CoLucid Pharmaceuticals Announce Agreement for Lilly To Acquire CoLucid

$960 million deal will enhance Lilly’s existing pain management portfolio for migraine; adds potential near-term launch to its late-stage pipeline

Eli Lilly and Company and CoLucid Pharmaceuticals, have announced an agreement for Lilly to acquire CoLucid for approximately $960 million. This transaction will enhance Lilly’s existing portfolio in pain management for migraine, while adding a potential near-term launch to its late-stage pipeline.

CoLucid Pharmaceuticals is a public biopharmaceutical company developing an oral 5-HT1F agonist (lasmiditan) for the acute treatment of migraine. CoLucid has completed the first of two pivotal Phase 3 trials. A data read-out for the second Phase 3 trial, SPARTAN, is expected in the second half of 2017. If this trial is positive, submission of lasmiditan for U.S. regulatory approval could occur in 2018.

More than 36 million people suffer from migraine in the United States alone. Lasmiditan, if approved, would be a first-in-class therapy to treat migraine through a novel mechanism of action without vasoconstriction. This could be desirable in migraine patients who have, or are at risk for, cardiovascular disease, as well as those who are dissatisfied with their current therapies.

Lasmiditan is an important addition to Lilly’s emerging pain management pipeline, which includes galcanezumab, a potential medicine in Phase 3 clinical development for the prevention of migraine and cluster headache. In addition, tanezumab is being studied, in collaboration with Pfizer, for the treatment of multiple pain indications, including osteoarthritis, lower back and cancer pain.

“Lasmiditan is a novel, first-in-class molecule that could represent the first significant innovation for the acute treatment of migraine in more than 20 years, and CoLucid has made significant progress in advancing this potential medicine,” said David A. Ricks, Lilly’s president and chief executive officer. “This innovation, along with galcanezumab, could offer important options for the millions of patients suffering from migraine.”

Lasmiditan was originally discovered at Lilly and was out-licensed to CoLucid in 2005. Over the past 12 years, CoLucid has taken important steps to decrease the risk related to development and commercialization of lasmiditan as evident by the first positive Phase 3 trial. At the time lasmiditan was out-licensed, pain management was not a strategic area of focus for Lilly. Lilly has since reorganized its research and development efforts to focus on migraine as part of its emerging therapeutic area of pain.

“We are excited that lasmiditan will be back at Lilly, where it was originally discovered, for the conclusion of Phase 3 development and potential commercialization,” said Thomas P. Mathers, CoLucid’s chief executive officer. “We are proud of the work that CoLucid has done to develop lasmiditan, and we believe Lilly’s expertise in pain and commitment to innovation are a natural fit to potentially bring this medicine to patients.”

About CoLucid Pharmaceuticals, Inc.

CoLucid was founded in 2005 and is developing lasmiditan oral tablets for the acute treatment of migraine headaches in adults and intravenous lasmiditan for the acute treatment of headache pain associated with migraine in adults in emergency room and other urgent care settings.

www.lilly.com/newsroom/social-channels

UNION PLASTIC presents its new innovative applicator cap APPLISIL® for vaginal cream

UnionPlastic

UNION PLASTIC is specialized from the design to the manufacturing of medical device and pharmaceutical primary packaging.

Developed in partnership with laboratories and end-users for 6 months, the company launches during PHARMAPACK 2017 a new innovative applicator cap for its APPLISIL® range of product.

This new innovative cap improves traditional devices with its reinforced hygiene, security and ease of use.

The applicator cap APPLISIL® allows a 2 in 1 use: an adaptable side to the main vaginal cream tubes and a side suitable to the vaginal applicators APPLISIL® (dosage from 0.5 to 5 ml).

This new product has a lot of advantages:

  • Total absence of particle discharges (aluminum and/or plastic)
  • Resealable stopper
  • Adaptable to several aluminum tube diameters
  • Reinforced hygiene
  • Adaptable to the applicators APPLISIL®
  • Tamper evident in option

The cap applicator APPLISIL® has got a patent registration and will be marketed from the second half-year 2017.

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Eric Goupil at Unither Pharmaceuticals inauguration in Wuhan (CH)

Unither

The unveiling ceremony of Unither Pharmaceuticals and Technology (China) took place on November 30th, 2016 at Biolake Industrial Park in Wuhan, Hubei Province. On this occasion, Mr. Eric Goupil was interviewed by Hubei TV.

All the contributors to the implantation of Unither Pharmaceuticals in Wuhan were present, including the General Consul of France in Wuhan, Philippe Martinet, the director of Health Department in Donghu district, Zhu Xiaochun, the general engineer of Biolake Industrial Park, Bao Junhua, and the CEO of Unither Pharmaceuticals, Eric Goupil.

The director of Wuhan’s Business France office, Alexis Caille, Science and Technology attaché at the French General Consulate in Wuhan, Philippe Maurin, Scientific Director of Unither Pharmaceuticals, Marc Maury, and Ni Zeng and Shaoxiong Zhong, project manager and business development manager at Unither Pharmaceuticals, all of them greatly contributed and made possible the opening of the Unither Pharmaceuticals site in China.

Hubei TV: What will you bring to the site of Unither in Wuhan?
Eric Goupil: Unither is a company that designs and manufactures medications. Initially, a commercial office and a laboratory will be set up on the Biolake site and then a production factory will be opened.

Hubei TV: Is the strategy of Unither Pharmaceuticals complementary to Biolake’s strategy?
Eric Goupil: There is a dual interest in being established in Biolake. Firstly, proximity to our partners will allow the direct exchange in the sharing of knowledge and, in the future, opportunities for co-development.

Hubei TV: What are the strengths of Unither Pharmaceuticals?
Eric Goupil: Thanks to our specialization in single-dose forms, we can offer products without preservatives, easy to carry and to use on a daily basis, which makes it easier to treat patients.

Hubei TV: Why did you choose Wuhan for this implantation?
Eric Goupil: From our first visit, we were very well received. The support of Biolake, as well as the strong French presence and the help of the Consulate, helped us to facilitate this implantation. We want to integrate into the local life and within Biolake which represents a site of future.

Visit Unither’s booth

Pulmonary & nasal drug delivery experts to attend RDD Europe 2017

RDD Europe 2017

Register now to attend the RDD Europe 2017 Scientific Conference to be held April 25-28, 2017, in Antibes, France.

The Respiratory Drug Delivery (RDD®) Europe 2017 scientific conference will welcome pulmonary and nasal drug delivery experts from around the world to Antibes, France, April 25-28, 2017. The joint organizers
of this event, RDD Online® and Aptar Pharma invite you to register at www.rddonline.
com/rddeurope2017.

Bringing the Respiratory World Together
Respiratory Drug Delivery Europe is a major conference bringing together experts from around the world to exchange emerging scientific knowledge and providing a dynamic forum for business networking. Approximately 450 delegates from 29 countries attended the 2015 edition in Antibes, France. RDD Europe attracts high level academic, industrial and regulatory scientists and clinicians. It is a must attend conference for companies involved in the research, development, testing and marketing of medicines, devices and services associated with
pulmonary or nasal products.

A premium, interactive three-day conference
This year, the conference will start with a plenary lecture entitled “Patient Focused Device Design: Addressing Inhaler Technique”, hosted by Federico Lavorini, M.D. PhD, Department of Experimental and Respiratory Medicine, Careggi University Hospital, Florence, Italy.

Subsequent sessions will focus on:
– Progress in Inhaled Drug Development
– Can Connected Devices Improve Respiratory Outcomes?
– Changing Regulations in Europe
– Achieving Deposition Equivalence
– Novel Approaches to Characterize Aerosol Dynamics
– Designing Inhalation Products in a Quality by Design Era

As part of the conference, RDD Europe 2017 will underline innovative research contributions in both podium and scientific poster sessions. Scientific posters will highlight recent nasal and pulmonary pharmaceutical research. Five of the best posters will be showcased during ‘Posters on the Podium,’ a fast-paced interactive session in
the main auditorium. All accepted graduate student poster abstracts are automatically eligible for the VCU RDD Peter R. Byron Graduate Student Award.

RDD Europe 2017 will also host 12 workshops led by device experts and service providers. Participants can self-select and attend interactive technical Workshops highlighting innovative technologies, products and services. Valuable networking opportunities RDD Europe 2017 offers numerous networking opportunities including the Technology
Exhibition. Exhibitors display innovative technologies and services throughout the conference in our signature table-top format. Device and equipment designers, and service providers, and consultants can interact and share their input.

A networking cocktail reception will take place on the evening of April 25 and a Gala Dinner sponsored by Aptar Pharma will be hosted on Thursday, April 27.

For many years, RDD Europe events have reached capacity, so early registration is strongly recommended. The early bird rate will be available until January 16, 2017.

Further information about RDD Europe 2017, including the detailed program and registration details, is available now here

Aptar Pharma nears completion of elastomer component capacity in North America

Aptar

Aptar Pharma, a leading provider of drug delivery systems, is nearing completion on its expansion at its Congers, NY state-of-theart manufacturing site. The new space will enable the company to better serve North American pharmaceutical customers, as injectable elastomeric component manufacturing will be completed in the United States for the first time by Aptar. Final construction is planned by the end of the first quarter of 2017 so that Aptar Pharma can anticipate shipping validation batches to customers in the second quarter of next year. The expansion is part of a stepped program to increase Aptar Pharma’s footprint in the United States, according to Bas Van Buijtenen, President of the Injectables Division of Aptar Pharma.

“This investment is continuing our commitment to growing and accelerating our footprint in North America. More significantly, the technology we are introducing will increase our ability to provide world-class manufacturing capabilities to our customers locally. This will provide premium products, shorter lead-times and more responsive service for the US elastomeric components markets,” Van Buijtenen said. The added space will house state-of the-art clean rooms and integrated best-in-class vision equipment, according to Van Buijtenen. “Vision equipment will be used to perform 100% of the automatic inspection of all parts during the finishing process to ensure PremiumVisionTM product quality,” he said. “The increased facility space also enables the company to conduct all of our finishing operations in the United States, including Aptar Pharma’s recently launched Premium Coat TM coated stoppers.”

The expansion was necessary to meet the continued growth of Aptar Pharma’s US injectables business and is part of Aptar’s multiyear investment program supporting the global growth of its injectables business. “We are bringing all of our knowledge and the value-adding parts of our process closer to the customer,” he added. “We want our customers to know us better. To understand what we can do for them on an entirely different level.” Van Buijtenen also commented, “We are a global player with a strong position in North America. Our integration into AptarGroup gives us access to the latest technologies, exceptional people and great financial stability. Our US business has been growing very rapidly, and this investment in capacity will support and accelerate our growth into the future.” he said.

INTERPHEX March 21-23, 2017 Javits Center, New York, NY

Interphex

Find all of the Solutions you need to Cost Effectively Develop and Manufacture Product.

INTERPHEX is a premier pharmaceutical, biotechnology, and medical device development and manufacturing event dedicated to Innovation, Technologies and Knowledge throughout the product development life cycle. It brings 11,000+ global industry professionals together with 600+ suppliers through our no cost technical conference, exhibits, and networking events.

www.INTERPHEX.com