Catalent Collaborates With Grid Therapeutics To Develop A Novel Targeted Immuno-Oncology Therapy

catalent

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.

Gx® InnoSafeTM: Optimal for pharmaceutical companies and healthcare professionals

bac

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.

SerThe 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 opens a new factory in Saint-Marcellin (France) dedicated to the future of healthcare

stiplastics

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.

Sti

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 to enter into long term global supply agreement with Fareva

fareva-v2

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 To Acquire Cook Pharmica For $950 Million

Catalent

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.

Unither Pharmaceuticals will attend the CPhI Worldwide 2017 in Frankfurt, Germany

unither logo

Meet Unither at Stand 4.1C80 on the 24-26 October 2017. This international partnering conference will be an excellent occasion to learn about their latest innovation: the orodispersible solutions. The orodispersible dosage forms have been developed to improve swallowing of oral dosage forms particularly for patients with dysphagia such as geriatric and pediatric population. 

Sanner invests in Bensheim production facility

Sanner

One year after its start, Sanner has successfully completed the “future project production area South”. During the project, the entire machine park in this area was replaced with 14 injection-molding machines of the latest generation. The Sanner team completed the project on schedule and within the designated budget. “Our goal was to further automatize production and consequently increase capacities and efficiency,” says Dirk Mähr, Managing Director of Sanner GmbH. “A goal we have definitely achieved.”

With this expansion, the company is taking another important step towards future-oriented production at its headquarters in Bensheim. The new injection-molding machines ensure faster processes and can be further automatized at any time. The packaging specialist is thus optimally equipped for the challenges of industry 4.0, as well as for further optimization projects. Over the next few years, Sanner will also consequently expand its portfolio in the areas of capsules and desiccant packaging.

“During the modification, we were also able to significantly reduce energy consumption in production in line with the Sanner sustainability concept,” Mähr adds. This includes, amongst others, a renewed media supply for cooling water and compressed air, a better raw material supply and the installation of new cranes. Thanks to new lighting and a reduced noise level, Sanner employees also benefit from easier workflows and better working conditions.

Nemera receives Drug Manufacturing Authorization for its Neuenburg plant, in Germany

Nemera

Important achievement for Nemera, now able to handle, assemble, sterilize and store pharmaceutical drugs and medicinal products for Autoinjectors.

On 4th September, Nemera received from the German Government Drug Administration (Government Presidium, Tübingen) the Pharmaceutical Drug Manufacturing Authorization according to §13 AMG (German Drug & Medicinal Product Law) at its Neuenburg manufacturing facility in Germany. The certification gives the manufacturing plant the approval to handle, assemble, sterilize and store pharmaceutical drugs and medicinal products for autoinjectors.

This approval reflects Nemera’s commitment to quality in developing and manufacturing drug delivery devices.

The Authorization is an important achievement. It confirms that Nemera meets the highest standards required to ensure the manufacturing and testing of the above-mentioned drug, as well as medicinal and medical products. The pharmaceutical drug manufacturing certification is a required regulatory step, in order to allow Nemera to provide a complete set of services and additional support, for the development and manufacturing of pharmaceutical combination products and drug delivery devices to our customers

“Achieving this pharmaceutical drug manufacturing approval is highlighting our commitment to ensure the safety of our drug delivery devices for the benefit of patients. It is also the confirmation that our quality systems and processes are meeting consistently regulatory requirements and patient expectations.” commented Christian Meusinger, Quality Vice-President of Nemera.

Neuenburg plant has been manufacturing high quality products since 1953.
With more than 20,000 sqm of built up area, the plant has Class 8 clean rooms and more than 400 employees, to guarantee a 7/7 and 24h/24 production.
Neunburg plant produces billions of Injection molded parts and assembled devices every year.

Neuenburg quality management key achievements are:

• Short reaction times
• Detailed and comprehensive root cause analysis
• Elimination of quality problems
• Reduction of scrap rates
• Elimination of inefficiencies
nemer

Gx® InnoSafeTM: customized for manufacturers and users

Ser

Gerresheimer presents at CPhI Worldwide in Frankfurt (Germany) an integrated safety system for the prevention of needlestick injuries

With their exposed cannulas, used syringes are an omnipresent source of danger in medical practices, 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 medical personnel. With Gx InnoSafe, Gerresheimer introduces a syringe with an integrated safety system for the avoidance of needlestick injuries that fulfils the current requirements of the pharmaceuticals industry and of users equally.

One careless movement is enough for medical specialists 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 additional actions. This thus involves a so-called passive needle protection system. Also of advantage to the pharmacists is the processing of the Gx InnoSafe syringes, which can take place on existing lines in the nested state without significant changes. An additional installation step of a safety system, as is usual on the market, is dispensed with.

The user wishes a safety system that leaves the familiar injection procedure unchanged, is intuitive and can be operated ergonomically, and which requires no additional manual activation to secure the cannula prior to disposal. The Gx InnoSafe  safety system is installed like a standard seal in the clean room on Gx RTF glass syringes in the context of the manufacturing process. The syringe body itself remains completely visible, so that the presence, filling level, and state of the active ingredient, as well as the injection procedure can be inspected without obstacles. The injection itself is administered as usual. Following the removal of the ergonomically optimized sealing cap with the integrated flexible needle shield, the syringe is positioned at the injection point, the cannula inserted into the tissue to be administered and the active ingredient injected as with a conventional syringe. An accidental triggering of the safety system isn’t possible, as the mechanism is completely relaxed prior to the injection. The system is first activated with the pricking 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 renewed use of the syringes is impossible.

bacFor the pharmaceuticals company, Gx InnoSafe offers advantages for the filling process of ready-to-fill syringes. The safety system is positioned fully automatically in the RTF process and visually inspected with an X-ray check to 100 percent for correct positioning. The syringes, including the safety system,  are packed in perforated trays and tubs and then sterilized with ethylene oxide gas. They can be processed on existing filling lines without additional preparation and assembly steps. Here too, the design of the safety mechanism ensures that unintended activation while filling, packaging, and transport is avoided. 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.

From October 24 to 26, Gerresheimer will be at CPhI Worldwide in Frankfurt (Germany) in hall 4.2 at booth D02.

Gx® and RTF® are registered trademarks of the Gerresheimer Group. InnoSafe is a pending trademark of the Gerresheimer Group.

Aptar Pharma to Highlight Key Innovations Addressing Today’s Megatrends in Drug Delivery at CPHI Worldwide in Frankfurt, Germany

Aptar

Aptar Pharma, a leading drug delivery systems provider, is pleased to once again be a main exhibitor at CPhI Worldwide 2017, which takes place in Frankfurt, Germany from October 24 – 26. For many years, Aptar Pharma has had a significant presence at this major event in the pharmaceutical industry.

This year, the Aptar Pharma booth, located at stand No. 42F10, Hall 4.2., will feature an innovation area showcasing seven healthcare technology megatrends, including a special connectivity hub, which will be dedicated to the growing field of connected healthcare solutions.

In addition to exhibiting at CPhI Worldwide, Aptar Pharma will present three Pharma Insight Briefings that will highlight its latest innovations and developments in the following drug delivery system areas:

 

Innovative Respiratory Solutions for Expanding Your Product Portfolio

Portrait 1Guenter Nadler, Director of Business Development at Aptar Pharma, will deliver an insightful talk on innovative respiratory solutions on the first day of CPhI Worldwide. As a global rise in allergies and air pollution have led to a significant increase in upper respiratory tract diseases, typical over-the-counter medications and household remedies cannot always fulfil the needs of today’s on-the-go lifestyle.

As one of the leading drug delivery system providers for the development of dispensing solutions for pharmaceutical cough and cold applications, Aptar Pharma’s proven nasal spray and Bag on Valve systems have become the treatment standard in the industry.
During the talk, attendees will learn more about how these systems meet today’s requirements for compliant patient treatment.

Join Guenter’s Briefing on Tuesday, October 24 at 10:30 at the Innopack Zone, G1A3.

 

Driving Better Patient Outcomes with Connectivity

Portrait 2Sai Shankar, Director Business Development – Connected Devices at Aptar Pharma, will present the company’s second Pharma Insight Briefing at CPhI Worldwide.

Using a patient-centric design approach, Aptar Pharma supports Pharma companies worldwide with custom-made solutions, including connected technologies, for the treatment of respiratory diseases including asthma and COPD. The findings of a study recently conducted by Aptar Pharma on its integrated connected pMDI, as well as the company’s connected health devices portfolio that support respiratory treatment for patients, will be among the topics presented at this briefing.

Join Sai’s talk on Tuesday, October 24 at 15:50 at the Innopack Zone, G1A3.

 

Setting New Standards for Coated Stoppers

Portrait 3

Arnaud Fournier, Business Support Manager for Injectables at Aptar Pharma, will exclusively introduce PremiumCoat ™, a coated stopper which represents a step change in the provision of elastomeric stoppers with an unrivalled, market leading reduction in particulates, and is Aptar Pharma’s response to the growing challenges to developing more sensitive drugs in the pharmaceutical market.

Join Arnaud’s presentation on the latest development in Aptar Pharma’s Premium Injectables portfolio on Wednesday, October 25 at 10:30 at the Innopack Zone, G1A3.

With over 42,000 Pharma professionals attending CPhI Worldwide every year, Aptar Pharma welcomes the opportunity to meet with their valued customers and business partners, exchange with key opinion leaders in the Pharma industry and showcase their latest key innovations.

Join Aptar Pharma at booth No. 42F10, Hall 4.2, where their team of experts will be pleased to give an overview of their wide product portfolio that provides innovative drug delivery systems, components and services covering a broad range of delivery routes.