PCI Pharma Services Announces First-of-Its-Kind Clinical Center of Excellence in Boston Area
PCI Pharma Services (PCI), a global CDMO, has announced the construction of a new Clinical Center of Excellence in Bridgewater, Massachusetts providing clinical storage, distribution and packaging to meet the growing New England clinical supply market demands. PCI is the first global CDMO with integrated end-to-end capabilities to build such a center, with a strong focus on cold chain capabilities, in New England. This major investment will allow PCI to be closer to its clients in the tri-state area and engage with more than a thousand new clients in Boston/Cambridge, the nation’s top biopharma cluster. This news comes after PCI’s recent announcement that it has signed a definitive agreement to acquire LSNE, a premier contract development and manufacturing organization headquartered in Bedford, New Hampshire.
“The biotech and pharmaceutical industries have been rapidly expanding in the Northeast, especially Boston, in the last few years, and this new Clinical Center of Excellence and our recent definitive agreement to acquire LSNE, will create more convenience and efficiencies for our Northeast clients by offering them a center that combines a local feel and global capabilities,” says Brian Keesee, Vice President and General Manager, Global Operations and Supply of Clinical Services, PCI Pharma Services. “This expansion is part of our larger strategy to serve biopharmaceutical clients by providing a facility that can service their needs within a relatively short driving distance, while adding to our global footprint.”
The 50,000-square-foot center is currently under construction with an expected completion of Summer 2022. Over the last 18 months, PCI has invested heavily in its global clinical sites including San Diego, Rockford, Melbourne and Berlin as part of its global clinical expansion in all services. This includes investing in new facilities, refrigerators and freezers, increasing capacity, and adding new storage conditions in service to both large and small molecule compounds.
“Our decentralized global offering that features several smaller hubs around the world is a key reason why we’re a leader in the clinical trials space,” says Salim Haffar, CEO, PCI Pharma Services. “This center will localize PCI’s global capabilities in the Boston area, providing our Northeast clients with critical services to facilitate the packaging and distribution of life-changing treatments.”
McKesson Opens State-of-the-Art Distribution Center in Michigan
McKesson Corporation has opened a new pharmaceutical distribution center in Holt, Michigan, seven miles south of Lansing. The facility will add more than 80 full-time jobs to the region, including day and night shifts offering competitive pay and benefits.
“It is my pleasure to welcome McKesson to the Lansing area as we have a shared focus on creating meaningful jobs for the district,” shared Senator Curtis Hertel, Jr. “We look forward to having them as a valuable and trusted community partner for years to come.”
Set on approximately 23 acres, the 174,000-square-foot facility is strategically located to serve customers across the state. The site features the latest in distribution technology including state-of-the-art automation that will optimize efficiency and productivity to serve customers, including hospitals, community pharmacies and national retail pharmacies.
“Our people are at the heart of our distribution centers, and we are thrilled to welcome the Holt team to the McKesson family,” said Ammie McAsey, senior vice president of customer distribution experience, U.S. Pharmaceutical. “This new facility and its central location expand access to life-saving medicines for our customers, and their patients across the state. It’s central to our mission to improve care in every setting – one product, one partner, one patient at a time.”
In addition to distribution technologies and efficiencies, this center also includes several energy-saving attributes, such as:
- A white roof that reflects sunlight and reduces heat
- Motion sensors to reduce unnecessary water and electricity usage
- An HVAC energy management system, which measures energy consumption and identifies opportunities to improve energy efficiency within the building.
These investments were made in anticipation of the formalization of McKesson’s first company-wide, science-based greenhouse gas reduction goal and will help reduce the company’s environmental impact.
Avantor Opens Second European Single-use Facility in the Netherlands; Supports Growing Demand for Bioproduction
Avantor announced that it has opened a new single-use facility in Hillegom, Netherlands in early October 2021. The site is Avantor's second single-use location in Europe after its Tilburg, Netherlands site and is a significant addition to the Company's overall cleanroom capacity in the region, servicing regional and global customers.
Located between Amsterdam and Leiden in the industrial corridor of the Netherlands, the Hillegom facility enables Avantor to manufacture, package and deliver single-use solutions that support all stages of biologics manufacturing including upstream, downstream and fill- finish.
"We continue to grow our single-use footprint and capabilities to serve the needs of the global biopharma industry," said Dr. Ger Brophy, Executive Vice President of Biopharma Production at Avantor. "We are proud to be part of the Hillegom community and boost our presence in the Netherlands. Opening this site also reflects our commitment to support the growing demand for speed and efficiency in bioproduction. This facility will enhance the regional single-use supply chain in Europe, and Avantor looks forward to continuing to grow our business in this important market."
In addition to its two sites in Europe, Avantor's global single-use footprint includes multiple sites in the United States as well as a site in Changzhou, China that was acquired as part of the Company's recent acquisition of RIM Bio. Additionally, Avantor has recently announced its intent to acquire Masterflex®, a leading global manufacturer of peristaltic pumps and aseptic single-use fluid transfer technologies, which will strengthen its offering across all bioproduction platforms.
Cardinal Health Awarded FDA Funding to Assess Real World Evidence Results Against Clinical Trials
Cardinal Health announced it has been awarded a $750,000 contract by the FDA to implement an 18-month real world evidence (RWE) study as part of the agency's efforts to advance the applicability of RWE in regulatory decision-making.
The funding, which will support the project "Assessment of a Novel Methodology for Endpoints Assessing Response to Lymphoma Treatment in Real-World Studies," will evaluate the accuracy of real-world data (RWD) for lymphoma tumor response compared to blinded independent central review, the gold standard in randomized clinical trials. Within this research, Cardinal Health will work with the FDA Oncology Center of Excellence to assess tumor response in the clinical care setting.
"The utilization of real world evidence can ultimately lead to improving the patient experience by providing quicker access to safer therapies, but only if the potential is fully realized by bridging the measures used in clinical trials to those observed in real world patients," said Eli Phillips, Jr., PharmD, JD, vice president of Regulatory Sciences and Insights & Engagement, Cardinal Health. "I'm proud that Cardinal Health's commitment to advancing patient care through the use of real world evidence for regulatory objectives has been recognized by the FDA with this award to further our research."
Since Congress passed the 21st Century Cures Act in 2016, the FDA has placed increased focus on evaluating opportunities to use RWD to support regulatory decision making, including supporting the expansion of indications for currently approved drugs. However, despite potential utility of RWD usage, the field currently lacks standardization in tumor response assessment that provide for reproducibility of results. This research could provide important insights to inform RWD study designs or study methodology for such a purpose.
WuXi Biologics Launches a New GMP Commercial Drug Product Facility
WuXi Biologics a global company with leading open-access biologics technology platforms, announced it has successfully launched the GMP operation of its new drug product facility located in Wuxi, China, which is the eighth operational drug product facility in the global network of WuXi Biologics.
The 12,000m2 drug product facility, called DP2, features a state-of-the-art isolator filling line for the continuous high-speed production of wide size range – from 2R to 50R of liquid and 20m2/40m2 of lyophilization. Leveraging its innovative design, the facility can switch rapidly between different specifications to maximize its filling efficiency, providing flexible drug product manufacturing solutions to meet customers' needs. DP2 will increase up to 60 million vials for commercial drug production of biologics per year. This facility serves as an example of WuXi Biologics' implementation of single-use technology as it utilizes disposable peristaltic pump filling systems and sterile filtration systems in pre-use post sterilization integrity testing (PUPSIT), which meet current and evolving global regulatory requirements.
With its advanced layout and equipment, the facility effectively eliminates cross-contamination and ensures product sterility while accelerating drug product services across multiple modalities – such as monoclonal antibodies, bispecifics and fusion proteins – and enables the company to initiate any client project within four weeks. The application of both single-use and stainless-steel formulation systems helps reduce energy consumption, resulting in greater productivity and lowered environmental impact.
Dr. Chris Chen, CEO of WuXi Biologics, commented, "We're excited about the successful GMP launch of the first fully automated vial packaging line as well as DP2, the largest commercial drug product facility at WuXi Biologics. These will allow us to further provide high- yield, high-efficiency, and high-quality drug product services to support our global clients' clinical trials, product registration, and commercial authorization."
Catalent Further Expands Clinical Supply Network with New Facility in San Diego
Catalent, a global leader in clinical supply services, today announced the opening of a new facility in San Diego, in response to increased demand from pharmaceutical and biopharmaceutical customers for integrated development, clinical packaging, and distribution solutions on the U.S. West Coast. The new facility marks the latest expansion to Catalent’s global clinical supply network, and follows the opening of a new site in Japan earlier this month.
The 24,000-square-foot facility, located within a mile of the company’s early-phase oral drug product center of excellence, has been established to support clinical studies in phases 1-3. The site offers end-to-end services including supply management, primary and secondary packaging and labeling, storage, distribution, returns and destruction.
“Our new full-service San Diego supply facility is strategically located to work in tandem with our development center and serve customers not only on the West Coast of the U.S. and Canada, but across the world,” commented Kristen DeVito, Vice President of Operations, Clinical Supply Services, North America at Catalent. “In addition to investments we have made across our global network, the site is part of a wider strategy to provide local, integrated supply services, which offer a supply chain advantage as the world adjusts to the impact of the pandemic and its inherent logistical challenges.”
With a network spanning the U.S., U.K., Germany, Singapore, Japan and China, and over 50 additional global depots, Catalent’s clinical supply services can handle a broad range of international compliance and distribution requirements to support global clinical trials.
Recro Announces New Agreement with Otsuka, Will Serve as a Commercial Supplier for Otsuka
Recro Pharma, a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, announced the signing of a master supply and services agreement with Otsuka Pharmaceutical Co., Ltd. (“Otsuka”). Under terms of the agreement, Recro will serve as a commercial manufacturing and supplier for Otsuka.
“The opportunity to support Otsuka’s supply chain risk management efforts while serving as their U.S.-based supply source represents a key milestone for Recro and underscores the continued momentum our company is generating in growing our CDMO business and diversifying our client base. This is a significant win for Recro and is a testimony to the hard work our tech transfer and production teams have put in over the past several quarters to get us to this point,” said David Enloe, chief executive officer of Recro. “We look forward to a long and productive collaboration with the Otsuka team as we support them in achieving commercial success across their product portfolio. Beyond our work with Otsuka, we believe this agreement highlights Recro’s ability to serve as a trusted U.S. supply source for other developers of small molecule therapeutics, thus helping to mitigate the growing global supply chain risk facing the biopharmaceutical industry.”
Rentschler Biopharma Appoints Dr. Robert Panting as General Manager of Center of Excellence for Cell and Gene Therapy
Rentschler Biopharma, a leading global contract development and manufacturing organization (CDMO) for biopharmaceuticals, today announced the appointment of Dr. Robert Panting as General Manager of Rentschler ATMP[*] Ltd. This center of excellence is in Stevenage, UK, Europe's largest cell and gene therapy hub. It was set up to address the gap in capacity and support for early-stage innovators in cell and gene therapy. In this position, Dr. Panting will manage all operations at the site.
“I am delighted to welcome Dr. Robert Panting to the Rentschler team. With his great experience running complex operations and setting up the structures needed for a new site, he is the ideal choice to manage our cell and gene therapy facility,” said Dr. Frank Mathias, CEO of Rentschler Biopharma. “We are excited by the great progress we have made since launching our plans in the UK earlier this year and look forward to establishing this facility for the state-of-the-art manufacturing of viral vectors for clinical supply. Dr. Panting’s leadership will be a critical aspect of driving this project to be client-ready for cGMP manufacturing.”
Dr. Panting, General Manager of Rentschler ATMP, added: “I am honored to join the Rentschler team and to manage operations at the company’s exciting undertaking in ATMP manufacturing. Rentschler Biopharma is highly regarded in the industry. I look forward to ensuring that the new site provides the reliable, client-focused, high-quality service for which the company is known. I also look forward to contributing to moving the business into new technologies and offerings. I am thrilled by the strong interest we have already seen for our ATMP services.”
Aptar Pharma and i2c Pharmaceutical Services Announce Partnership
Aptar Pharma, a global leader in drug delivery systems, services and active material science solutions, and i2c Pharmaceutical Services, a leading service provider for the development of pharmaceutical formulations, today announced an exclusive partnership to co-develop and promote i2c’s patented pressurized metered-dose inhaler (pMDI) technology, Respitab®.
As part of the agreement, Aptar Pharma, who is the market leader in pulmonary drug delivery device solutions for the management and treatment of asthma and chronic obstructive pulmonary disease (COPD), will evaluate the commercial applications for Respitab, in particular for new, lower global warming potential (GWP) propellants.
Respitab is a propellant dispersible tablet that eliminates the need for a complex mixing process used in standard pMDI manufacturing. A patented, innovative platform that enables the transition to the next generation of pMDIs for a range of active pharmaceutical ingredients (APIs) and combination products, Respitab is also a cost-effective approach for the new chemical entity (NCE) and generic pMDI products, simplifying the manufacturing process for HFC 152a and other propellants.
Suitable for APIs with different physicochemical properties, Respitab has highly efficient aerosol properties and dose uniformity characteristics. Respitab’s other advantages include reduced waste and API losses, as well as ease of scalability.
Howard Burnett, Vice President Global Pulmonary Category, Aptar Pharma commented, “We are pleased to partner with i2c on this novel technology which brings many benefits to the filling of metered-dose inhalers. This development further enhances Aptar Pharma’s industry-leading portfolio of devices, which, combined with our broad spectrum of Aptar Pharma Services, allows us to offer end-to-end support to our clients and partners.”
“We are excited by this partnership with Aptar Pharma which brings together substantial synergies to provide a lower GWP product range to patients in the pMDI format, the most popular inhaler type across the globe,” added Glyn Taylor, CSO of i2c Pharmaceutical Services.
Pinnacle 21 Awarded FDA Contract for 5 Years for Software and Services
Certara, a global leader in biosimulation, announced that the FDA awarded a five-year contract with Pinnacle 21 for ongoing software and related services support for the agency’s DataFit program. The DataFit program assesses data quality and performs data validation for standards compliance of all electronic clinical and non-clinical trial study submission data. This agreement is similar to the contracts awarded to Pinnacle 21 in 2015 and 2011 by the FDA. Pinnacle 21 was acquired by Certara in October 2021.
“We are honored by the FDA’s continued support of our Pinnacle 21 Enterprise software and partnership,” said William F. Feehery, PhD., CEO of Certara. “We are dedicated to making the drug development and submission process more efficient and user-friendly for regulatory agencies and biopharmaceutical companies, helping to get crucial new therapies to patients sooner.”
The DataFit custom implementation of Pinnacle 21 Enterprise meets the FDA's data fitness assessment needs. The Pinnacle 21 Enterprise software enables the FDA to perform large-scale data validation and data quality reporting. FDA reviewers can assess and understand the quality of incoming submission data at a summary level in hours instead of the days or weeks required in a manual review.
“Regulatory agencies are embracing change and innovation to streamline the submission process. As the compliance standards are not easy to navigate, our software helps to automate validation and identify issues,” said Max Kanevsky, chief technology officer of Certara’s Software business unit. “Furthermore, beginning last month, the FDA is enforcing the technical rejection criteria, which are applicable to submissions to the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research.”
Masco Group Acquires Keyplants AB, a Global Provider of Modular Life Science Facilities
Masco Group, global provider of technological solutions for the pharmaceutical and biotech industries, has acquired a majority stake in Swedish company KeyPlants AB. The move will strengthen Masco’s leadership in engineering technologies for life sciences.
KeyPlants is an international industry partner for standardized as well as customized process-integrated modular prefabricated facility solutions. Based in Stockholm, the company has a fully integrated supply chain with more than 45 years of experience in project engineering, production and delivery, and has supplied more than 3,500 high-specification modules to at least 30 countries.
This partnership will strengthen Masco Group by combining its leadership in clean utilities and process technologies with KeyPlants’ expertise and innovative energy in prefabricated, modular facility solutions. It will support stronger value propositions for global supply chain challenges such as flexibility, reliability and fast-track manufacturing timelines to a global customer base of biopharmaceutical manufacturers and CDMOs focused on biologics, pharma and advanced therapy medicinal products (ATMPs), such as cell & gene therapies.
“We are extremely happy to partner with KeyPlants, as it will expand our capabilities, service and product offerings, and evolve our manufacturing capacity,” says Luca Borella, CEO of Masco Group. “We look forward to working with them to further accelerate the global adoption of their innovative fast-track facility solutions, which are an essential aspect in the life science industry.” He adds: “The companies share similar values, notably the commitment to teamwork, sustainability and customer care. Innovation is also an important synergetic element.”
“KeyPlants’ management and team are fully committed to this partnership with Masco Group,” says Jörgen Harrysson, Managing Director and Board Member of KeyPlants AB. “Its global presence and network enables KeyPlants to continue with our strategy to serve existing and new clients with our fast-track solutions, including customized facilities as well as standardized PODs. We are also thrilled to be able to expand our presence and offerings in North America, Europe and Africa.”
“We see KeyPlants and Masco Group as a perfect fit, and we are excited at the prospect of making KeyPlants and its skilled teams an integral part of the growth trajectory of the Masco Group family,” comments Frans K. A. Maas, Masco Group Board Member. “Masco Group is part of RSBG SE, a German-based long-term industrial partner of successful medium-sized companies, pursuing a buy-and-build strategy and focusing on competences and areas which are of great importance during global transformations. This acquisition supports the vision to become a technology-leading turnkey provider, in particular in the growing and demanding markets of biologics, vaccines and ATMPs.”
Biosynth Carbosynth and Shengquan Acquire New Plant to Increase Production Capacities in China
Biosynth Carbosynth, a life sciences reagents and custom synthesis and manufacturing services company, and JINAN SHENGQUAN GROUP SHARE-HOLDING CO., LTD. announced their acquisition of Kexing Biopharmaceutical Co., Ltd’s raw material factory in Jinan, China. With this acquisition, Biosynth Carbosynth’s and Shengquan’s joint venture Carbotang expands the production capacities significantly. The more than 30,000 square meter property contains a comprehensive factory building on 5 floors, a demo workshop and a large warehouse including a state-of-the-art dangerous material storage. The expansion through a further production site now allows the group more flexibility and larger production volumes together with an increased production reliability. This is an essential prerequisite in the production of Biosynth Carbosynth’s products.
Dr. Urs Spitz, CEO of Biosynth Carbosynth said “We are delighted to be further expanding our manufacturing operations and hugely successful joint venture. With this strategic acquisition we can continue to deliver our enormous range of products at increasing scales, with unrivalled expertise in complex organic chemistries.”
Partnership Between Carina Biotech and CellVec Enables Advancement of Clinical Trials
Singapore-based viral vector CDMO CellVec has been selected as the manufacturer of choice for Australian cell therapy immuno-oncology company Carina Biotech, undertaking the production of GMP- compliant lentivirus constructs for its LGR5 CAR-T. The partnership is slated to advance clinical trials for a treatment designed for patients with advanced colorectal (bowel) cancer.
CellVec is a certified GMP gene therapy contract development and manufacturing organization that provides an advanced lentiviral vector platform to upscale production of viral vectors and develop novel gene transfer technologies to advance therapies to clinical application. Its strategic offering of bespoke manufacturing services will enable the clinical grade lentivirus to be produced under GMP standards while using Carina’s proprietary manufacturing process, progressing the production of LGR5 CAR-T cells for a first in-human clinical trial in H2 2022.
“The partnership with Carina Biotech marks a significant milestone for us to facilitate the furtherance of gene therapies. It attests to our capabilities to effectively scale bespoke viral vector manufacturing processes, enabling the advancement of different clinical therapies from bench to bedside that will benefit more patients across the world. We look forward to supporting Carina in the successful development of its LGR5 CAR-T cells,” said Dr Ang Peng Tiam, Chairman of CellVec and Medical Director of Parkway Cancer Centre, the largest private oncology service provider in the region.
“We are delighted to be working with CellVec because of their outstanding track record and expertise,” said Professor Simon Barry, VP of CAR-T Manufacturing Research and Development and the co-inventor of Carina’s lead CAR-T cell. “Their flexibility and willingness to incorporate Carina’s proprietary manufacturing process was an important consideration in the selection of CellVec as our service provider.”
Leveraging its advanced CellVec Vector Platform, CellVec’s efficacious manufacturing processes will scale the production of high-titre, high yield lentivirus constructs in an accelerated timeline (6 to 8 months) for the project. The LGR5 CAR-T cell targets the LGR5 cancer stem cell marker that is highly expressed on advanced colorectal cancer and some other cancers, resulting in durable tumour suppression and the prevention of relapses commonly seen in patients with colorectal cancer.
“We are continuing to see fantastic results with our LGR5 CAR-T cell in pre-clinical testing. Colorectal cancer is Australia’s second deadliest cancer and its incidence is rising in people under the age of 50 – with many of these people being diagnosed with advanced disease and a very poor prognosis,” said Dr Deborah Rathjen, CEO of Carina Biotech.
“After our recent successful capital raise and welcoming new impact investors to our company, we are on track for a pre-IND submission in Q2 of 2022 and an IND submission to the FDA in the second half of 2022 and the initiation of a Phase I/II clinical trial in patients with advanced colorectal cancer.”
Commenting on the potential of the partnership, Dr Gayatri Sharma, Chief Commercial Officer of CellVec said, “Carina’s work in LGR5 CAR-T therapy aligns strongly with our mission of innovating for patient benefit. Our manufacture of the required lentivirus constructs will accelerate the clinical application and adoption of the therapy, bringing it to more patients around the world and ultimately reduce the incidence and mortality of colorectal cancer. We are pleased to be part of this journey with Carina and are extremely excited for what this will bring to the colorectal cancer community.”
CellVec boasts a GMP-certified pharmaceutical quality system (PQS) and facility, awarded by the Health Sciences Authority of Singapore under current PIC/S guidance annexes for medicinal products. These are designed in alignment with US FDA, EU GMP and TGA (Australia) regulations and industry expectations. With a strategic location in Singapore, the region’s biotech hub, CellVec is able to facilitate on-time delivery of quality viral vectors across the world, including to the US and the UK.
Meiji Seika Pharma: Adcock Ingram Ltd. in India to Build a New Manufacturing Facility to Enhance Its CMO Business
Meiji Seika Pharma Co., Ltd. has been decided to construct a new manufacturing facility at Adcock Ingram Ltd. (Headquarters: Bengaluru India, Managing Director: G.V. Ramireddy) in Bengaluru, India, to enhance its production capacity of the contract manufacturing organization (CMO) business.
Adcock Ingram Ltd., established in 2007, is a joint venture between Adcock Ingram Holdings Ltd., in South Africa, and Medreich Ltd. (Headquarters: Bengaluru India, Managing Director: Pankaj Garg), a wholly-owned subsidiary of Meiji Seika Pharma Co., Ltd. Adcock Ingram Ltd. manufactures pharmaceutical products, by contract manufacturing, and distributes for the South African, European and Oceanian markets. By adding the new manufacturing facility, it can manufacture pharmaceutical products not only for the Adcock Ingram Group, but also for other clients. The new manufacturing facility is built at a subsidiary of Adcock Ingram Ltd. and is scheduled to start operation in March 2023.
The Meiji Group's Pharmaceutical Segment, in its "2023 Medium-Term Business Plan", has set an agenda to "Expand CMO/CDMO business" in its business strategies. We will continue to optimize our production bases in Japan and overseas to strengthen our production system and establish a system for the stable supply of highly reliable pharmaceuticals and contribute to improving access to pharmaceuticals for people over the world.
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