At Pharmapack Europe in Paris, visitors to booth C46-47 can see the whole range of desiccant solutions from Sanner, the manufacturer of high-quality primary plastic packaging and medical devices. In addition to integrated desiccants, Sanner presents its innovative drop-in solutions AdPack® and AdCap®. The AdPack® desiccant sachets made of Tyvek® material offer an ideal combination of breathability, moisture protection and durability. The desiccant capsules AdCap®, in turn, combine the advantages of conventional capsules and canisters, while offering high stability and a 30-percent higher moisture adsorption. Their unique grid structure enables 360-degree moisture adsorption and prevents mistakes during ingestion.
More than 40 government officials and 60 representatives from pharmaceutical and medical device companies attended the recent grand opening celebration for Tekni-Plex, Inc.’s new state-of-the-art manufacturing facility in Suzhou, China, near Shanghai. Plant tours and a luncheon followed the opening ceremony. Earlier this year, Tekni-Plex announced a $15 million investment in the facility to support the growing needs of the Asia-Pacific pharmaceutical and medical device markets that are supported with products developed by Tekni-Plex’s Colorite, Natvar and Action Technology business units.
Tekni-Plex senior management in attendance at the ribbon cutting included Paul Young, chief executive officer; Russell Hubbard, vice president-international and general manager; Ian Kenny, global managing director, Colorite; Johan Laureys, global vice president of Action Technology, and Bob Donohue, general manager of the company’s Natvar business unit. Xu Xiaofeng, standing committee member of CPC Wujiang Committee and deputy party secretary and vice chairman for Wujiang government, was also in attendance.
The more than 140,000-square-foot (13,000-square-meter) facility is manufacturing Tekni-Plex’s Natvar, Colorite and Action Technology products. The facility features three Class 100K cleanrooms to accommodate medical-grade tubing and components production plus one Class 10K cleanroom that will produce Natvar’s pharma-grade tubing.
The facility is in the process of commercializing Natvar’s recently-announced silicone extrusion tubing for catheters, feeding tubes, drug delivery and peristaltic pump applications. Production for microextrusion tubing that targets a wide variety of demanding neurovascular interventional therapies and surgical applications is expected to be on stream early next year. The facility will also manufacture Colorite custom compounds for medical device applications, and Action Technology’s dip tubes used in a wide variety of food/beverage, pharmaceutical, personal care, industrial and household pump applications.
Almac Group, the global contract development and manufacturing organisation, has announced the acquisition of BioClin Laboratories, an independent and privately owned organisation based in Athlone, Ireland.
Established in 2002 and located in Garrycastle, just two hours away from Almac Group’s Headquarters in Northern Ireland, BioClin is internationally recognised for providing expert analytical services including cGMP pharmaceutical and biopharmaceutical analysis, GMP microbiology testing and GLP bioanalysis. The company also boasts Ireland’s leading GLP certified (INAB), cGMP certified (HPRA) and FDA registered contract laboratory.
BioClin’s bespoke 14,000sq ft modern facility significantly increases Almac’s analytical capacity and perfectly complements its existing business enabling strategic expansion and greater ability to serve clients’ needs globally. The acquisition will see BioClin’s analytical experts join Almac Sciences’ strong network of almost 600 employees across multiple sites in Europe and North America.
Almac also recently completed significant expansion of its existing analytical facilities at its global headquarter site in Northern Ireland with the creation of a new, bespoke, MHRA approved laboratory.
News of this acquisition comes just days after announcing a multi-million pound expansion of Almac owned, Arran Chemical Company, also based in Athlone, which substantially increased Almac’s manufacturing capacity for fine chemicals, pharmaceutical intermediates and advanced building blocks.
“We are delighted to announce this acquisition demonstrating further commitment to strategic growth and development of our global business.” stated Dr Stephen Barr, Managing Director, Almac Sciences. “Adding BioClin’s highly complementary analytical capacity and technical expertise to our existing capabilities, we are able to broaden our service offerings and address our global clients’ growing demands for a high quality, integrated, efficient service. We look forward to working with the BioClin team and plan to invest significantly in this facility.”
Mary Burke, Managing Director, BioClin Laboratories commented “We are very pleased to join Almac. With our shared values for outstanding quality, expertise and innovation we see this as an excellent strategic fit for BioClin enabling us to expand and deliver an enhanced range of analytical solutions to an international client market.”
AptarGroup announced that it was awarded the inaugural Excellence in Pharma: Sustainability Initiative of the Year at CPhI Worldwide 2017. The award was presented as part of the CPhI Pharma Awards Gala, which took place Tuesday, October 24 at the Intercontinental Hotel in Frankfurt, Germany.
Established in 2004, the CPhI Pharma Awards are one of the most prestigious recognitions in the Pharmaceutical industry today. This year’s awards included eight new categories to further reflect the industry’s diversity. The Sustainability Initiative of the Year is one of this year’s new categories. There were over 200 entries across the 19 award categories, and finalists for the awards were announced in August 2017.
Aptar was awarded the Excellence in Pharma: Sustainability Award for its Landfill Free Certification program, a global internal certification program which promotes the efficiencies and conservation of natural resources in a manufacturing setting. Facilities that achieve at least a 90 percent reuse and/or recycling threshold are eligible to receive internal Landfill Free Certification. With more than 40% of Aptar’s manufacturing sites already certified through this program, Aptar has achieved significant accomplishments in waste reduction, cost savings and employee engagement. The program is incorporated as a measurable aspect of Aptar‘s global sustainability strategy and Aptar anticipates more facilities will achieve certification in years to come.
Data from Aptar’s recent customer satisfaction surveys demonstrated the growing importance of sustainability to customers and supply partners. Therefore, Aptar’s internal program further reinforces that Aptar is prioritizing the needs of its customers in line with its own company mission and corporate social responsibility.
Yann Ghafourzadeh, VP, Sales & Operations Europe – Prescription Division, commented, “We are delighted to have been awarded the Sustainability Initiative of the Year at the CPhI Pharma Awards. It is great to be recognised for the progression of Aptar’s Landfill Free Certification program, which has been significant within our global sustainability strategy. We have aligned our program with our customers’ requirements and we are dedicated to responding to what sustainability considerations are important to them. We look forward to further Aptar facilities obtaining the internal Landfill Free Certification in the future.”
• RayDyLyo®, an innovative device for vial capping
ARaymondlife is a pharmaceutical company GMP EU, specialized in plastic injection molding and fastening solutions. Its technological expertise is applied to develop innovative solutions for the pharmaceutical laboratories (for human health and veterinary medicine) and the medical industry.
Since 2012 ARaymondlife has been offering its own range of patented all plastic caps as an alternative to aluminum crimped closures. RayDyLyo® is more than a product; it is a solution that simplifies and improves the process security of the vial capping operation. Several packaging options are available in bulk or in nests to meet the market’s diverse needs. The trend toward ready-to-use components and filling vials directly in nests makes RayDyLyo® a very well-adapted solution.
RayDyLyo® eliminates the need for crimping by pre-assembling the stopper in the cap and closing the vial by simple vertical pressure, either automatically or manually.
• The first filling line adapted for RayDyLyo®
Dara Pharmaceutical Packaging was showing the first vial filling line specially adjusted for filling and capping vials with RayDyLyo® at the CPhl in Frankfurt (24-26 October 2017).The Spanish company responded to ARaymondlife’s request to develop a suitable machine for feeding the all-in-one solution (a stopper pre-assembled in the plastic closure) and the specific parts needed to adapt the line.
Pre-assembling the stopper upstream simplifies the process compared to a traditional line by eliminating thestopper placing and crimping operations and saves space in the clean room.
« We believe that this first filling line will be introduced to the market progressively, but we are convinced that this product will gain significant market share in the medium term. DARA new vials filling lines, are ready to implement this new technology. Also and this is the most important thing, DARA old machinery, due to its modularity construction, allows an easy, economical and fast retrofit, to combine this new RayDyLyo® system with the traditional stopper and alu cap technology. RayDyLyo® is a highquality product that fits perfectly with Dara’s filling lines. » Joan Melé, Dara Pharmaceutical Packaging Commercial Director.
For its development, ARaymondlife has already concluded other partnerships, in particular with the “Matrix Alliance”, on the initiative of Vanrx Pharmasystems, allowing to propose an aseptic filling solution in a fully robotized isolator, or more recently with Disposable-Lab Eurofins Amatsigroup to offer to biotechs and pharmaceutical companies a global solution for the aseptic filling of innovative biological products.
“We want to continue to develop industrial partnerships such as the one with Dara Pharmaceutical Packaging because we are convinced that we are stronger together and that the answers we bring to the market are more relevant,” explains Nicolas Thivant, President of ARaymondlife.
• Innovation and diversity are part of ARaymond’s DNA
Discovering new markets where its know-how and its potential for innovation make sense has been the driving force behind ARaymond’s development for more than 150 years. As one of the world leaders in fastening and assembly solutions for the automotive industry, it has gradually transferred its skills and expertise to new markets: Truck, Industrial, Energies, Agriculture and Life.
« We believe in ARaymondlife’s potential because it is an ambitious project driven by the passion and involvement of the people who lead it and it respects the values of our company. We are convinced that our employees’ enthusiasm and motivation will make a difference over the long term, » says François Raymond, General Director of the ARaymond Network. For the company, diversification also means ensuring its stability and independence despite the political and economic uncertainties that may affect a sector or a country.
Catalent Pharma Solutions has signed a multi-year agreement with Grid Therapeutics, LLC, for the development and manufacture of Grid’s lead therapeutic candidate for the treatment of solid tumors. Grid is an oncology-focused biotech company building on the innovative science first developed by Edward F. Patz, Jr. MD, and his team of scientists at Duke University Medical Center.
Under the agreement, Catalent Biologics will employ its proprietary GPEx® cell line technology to develop cell lines and manufacture antibodies with a view to optimizing the process for cGMP bulk drug production. The project will be undertaken at Catalent’s state-of-the-art Madison, Wisconsin, biomanufacturing facility.
Grid’s research is based upon a novel approach to identify specific tumor immunoglobulin G (IgG) antibodies from patients with early stage cancer. Grid used a unique strategy to obtain the sequence of its lead IgG3 antibody directly from B cells in cancer patients.
“Grid Therapeutics is excited to partner with Catalent to develop this novel, human-derived antibody for the treatment of cancer. We feel Catalent Biologics is well positioned to bring this novel antibody to the clinic,” commented Edward F. Patz, Jr. M.D., CEO of Grid Therapeutics.
“Catalent regularly and successfully partners with innovator companies looking to bring new, important therapies to market faster, and a patient derived IgG3 monoclonal antibody would be a significant advancement in optimized treatments,” commented Mike Riley, Vice President & General Manager of Catalent Biologics.
Catalent’s proprietary GPEx technology creates stable, high-yielding mammalian cell lines with high speed and efficiency. The advantages of applying GPEx technology span from early feasibility studies, to clinical manufacturing, through to commercial-scale production. To date, seven GPEx-based antibody and protein products are approved and marketed, and 34 therapeutic candidates are currently in the clinic across the world.
Gerresheimer was presenting at CPhI Worldwide in Frankfurt (Germany) an integrated and passive safety system for the prevention of unintentional needlestick injuries.
With their exposed cannulas, used syringes are an omnipresent source of danger in doctor’s surgeries, labs, or hospitals. Existing needle protection systems reduce the risk of injury for the user, but require additional effort for filling on the part of the pharmaceutical companies and with respect to the use of the syringe by healthcare professionals. With Gx® InnoSafeTM, Gerresheimer now offers a syringe with an integrated and passive safety system that prevents unintentional needle stick injuries, excludes the possibility of accidental reuse and takes the needs of pharmaceutical companies and health care professionals equally into account.
One careless movement is enough for healthcare professionals to injure themselves on unprotected, used syringe cannulas or come into contact with aggressive active ingredients. In the most adverse case, this can result in serious infections. There is also a danger that already used syringes may accidentally be used a second time. Gx InnoSafe provides reliable protection against needlestick injuries and eliminates the possibility of reuse. In contrast with many existing solutions, the needle protection mechanism is thereby activated automatically and requires no further handling steps by the end user. This thus involves a so-called passive needle protection system. Also of advantage to the pharmaceutical companies is the processing of the Gx InnoSafe syringes, which can take place on existing filling lines in the nested state without significant changes. An additional assembly step of a safety system, as is usual on the market, is dispensed with.
The user wants to have a safety system which remains the injection process unchanged, ensures an intuitive and ergonomical handling and does not require any additional operating steps for securing the cannula prior to disposal. The Gx InnoSafe safety system is installed like a standard needle shield in the clean room on Gx RTF glass syringes in the context of the manufacturing process. The syringe body is completely visible in order to be able to optimally see and check the presence of the active agent, its purity and the administering. The injection itself is administered as usual. Following the removal of the ergonomic sealing cap with integrated flexible needle shield, the syringe is positioned at the injection point, the cannula inserted into the tissue and the active ingredient injected like with a conventional syringe. An accidental triggering of the safety system is prevented, as the mechanism isn’t preloaded prior to the injection. The system is first activated with the piercing of the cannula and then automatically ensures when removing the syringe from the injection point that the safety mechanism is permanently locked. In this way, the cannula is reliably covered and reuse of the syringes is excluded.
For the pharmaceutical company, Gx InnoSafe offers advantages for the filling process of ready-to-fill syringes. The safety system is installed fully automatically like a standard needle shield in the clean room onto Gx RTF glass syringes and checked to 100 percent by visual inspection for potential needle piercing and safety system position. The syringes are then packaged, sealed and sterilized with ethylene oxide gas including the safety system in a 100 hole tray (nest) and in a tub. They can be processed on existing filling lines without additional preparation and assembly steps. The design of the safety mechanism ensures that unintended activation while filling, packaging, and transport is avoided. The flexible needle shield is available in all customary available elastomers for pharmaceutical applications. With the introduction of the new product line Gx InnoSafe is available for the 1.0 ml long RTF glass syringe with a ½“ cannula. Additional syringe variants will follow.
Gx® and RTF® are registered trademarks of the Gerresheimer Group. InnoSafe is a pending trademark of the Gerresheimer Group.
Stiplastics, the specialist designer, developer and producer of plastic solutions for the pharmaceutical industries and the health and e-health sectors has opened its new factory in Saint-Marcellin. A total of €8.6 million has been invested in this site, enabling the company to pool all its operations and meet its customers’ various requirements, especially in terms of the increasing demand for connected health.
A cutting-edge production tool
The 10,000 m2 site in Saint-Marcellin in the French département of Isère includes the company’s administrative headquarters, design office and production workshops (injection, assembly, storage) where manufacturing is based on lean management principles. It has:
– A dedicated injection workshop with 23 electric injection moulding machines weighing 30 to 300 T
– An automated assembly area (camera inspections, robot stations) and storage area
– A test centre with a dedicated injection moulding machine
In response to the rise of e-health, Stiplastics has also set up a new electronics workshopequipped with special tools including test benches. This 150 m² space is protected from ESD (Electro Static Discharge) by a controlled environment essential for handling electronic components.
The increasing prominence of connected care has also prompted the company to set up IoC [Internet of Care]®. This label and unit is dedicated to designing, developing and producing ehealth medical devices, with the main aim of significantly improving treatment and patient comfort.
Stiplastics is therefore now able to design and manufacture medical devices, add electroniccomponents, test them and then pack them ready-to-use for delivery.
‘In 2013, we drew up a development plan forecasting almost doubled sales in five years. This investment will enable us to meet our targets since we are still on track for turnover of €23 million by the end of 2018. It would not have been possible to build this new site so quickly without the effective contribution made by our staff, which I would like to acknowledge, and the unfailing support of the local authorities, especially the Pays de Saint-Marcellin Community of Municipalities and the City of Saint-Marcellin, who I would like to sincerely thank,’ says Jérôme Empereur, CEO of Stiplastics.
‘Since 2014, when we entered a true partnership with Stiplastics, immense progress has been made with connected health, a sector that gives much hope, especially in terms of allowing patients to continue living at home. This public health issue is particularly challenging for less urban local authorities like our own. We are therefore happy and proud to have supported and gained the loyalty of an innovative company involved in the future of healthcare. Its dynamism adds to the appeal of our community of municipalities and, we hope, will encourage other companies to set up in our booming region set in an ideal location at the foot of the Vercors mountains near major motorway links,’ explains Frédéric de Azevedo, head of the Saint-Marcellin Vercors Isère Communauté community of municipalities.
Walgreens Boots Alliance today announces a binding offer from Fareva for a ten-year global agreement for the manufacture and supply of own beauty brands and private label products, including products for sale in the USA. The proposed agreement will create a partnership to provide Walgreens Boots Alliance with a core multinational manufacturing and development resource, enabling the Company to accelerate its global product strategy.
Under the terms of the offer, Fareva will take ownership of BCM, Walgreens Boots Alliance’s contract manufacturing business, which operates factories in the UK, France and Germany.
Fareva manufactures in 11 countries, including the USA, and has significant research and development capabilities.
The proposed agreement, which is subject to Works Council consultation and regulatory approval, is expected to be completed by the end of calendar year 2017.
Catalent has reached an agreement to acquire Bloomington, Indiana-based Cook Pharmica LLC, an integrated provider of drug substance and drug product manufacturing and related services. The acquisition will strengthen Catalent’s position as a leader in the rapidly growing area of biologics development and analytical services, manufacturing, and finished product supply.
Cook Pharmica is a privately held, biologics-focused contract development and manufacturing organization with capabilities across biologics development, clinical and commercial cell culture manufacturing, formulation, finished-dose manufacturing, and packaging. Founded in 2004 as a division of the Cook Group, Cook Pharmica today operates a world-class, 875,000 square foot development and manufacturing facility in Bloomington. For the twelve months ended June 30, 2017, Cook Pharmica generated $179 million in revenue.
“The complementary biologics development, biomanufacturing, and fill-finish capabilities of Catalent and Cook Pharmica will provide biopharmaceutical firms with a single, integrated partner supporting a wide range of clinical and commercial needs,” said John Chiminski, Chair and CEO of Catalent. “We are very excited to join forces with the talented Cook Pharmica team in Bloomington, Indiana and plan to invest aggressively there, in our rapidly expanding Madison, Wisconsin facility, and in the rest of the Catalent Biologics network to build a true global leader in the biologics market, which will help us to improve the lives of patients around the world.”
Mr. Chiminski added, “This acquisition is also a recognition of the hard work, dedication, and community spirit of the team who have helped Cook Pharmica grow, and of the Bloomington area, which is such a terrific home for this fast-growing business. We look forward to strengthening Cook Pharmica’s partnership with the community in the years to come as we further strengthen our leadership position in biologics.”
Catalent Biologics currently offers a global site network, including a state-of-the-art biologics development and biomanufacturing facility in Madison; fill-finish services in Brussels, Belgium and Limoges, France; SMARTag® conjugation technology in Emeryville, California; and a network of biologics analytical locations.
Cook Pharmica’s Bloomington facility has extensive biomanufacturing capacity and deep expertise in sterile formulation and fill/finish across liquid and lyophilized vials, prefilled syringes, and cartridges. It perfectly augments Catalent’s expertise in cell line engineering, bioconjugate development, analytical services, biomanufacturing, prefilled syringe, and blow/fill/seal technologies.
Upon completion, Cook Pharmica’s over 750 associates, including its experienced executive team, will join Catalent’s network of more than 30 sites across five continents with more than 10,000 team members and complement Catalent’s existing biologics capabilities, alongside its other leading capabilities in oral, inhalation, and consumer health.