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TRUSTlab Diagnostics expand across India by opening 6 new labs

TRUSTlab Diagnostics has announced a significant expansion initiative across India, representing a huge step towards its mission of delivering accessible, precise and top-quality diagnostic services nationwide. In a move that underscores its unwavering commitment to excellence, TRUSTlab Diagnostics takes pride in introducing the inauguration of five new state-of-the-art laboratories. These cutting-edge facilities are situated in Noida, Patna, Bengaluru and at Hanamkonda & Karimnagar in Telangana. Additionally, TRUSTlab has established a collaboration with Blossom Hospital in Rajahmundry for their lab services. In the current fiscal year of 2023, TRUSTlab has already opened 10 such labs, and they plan to open an additional 7 labs by March 2024. These newly established laboratories will offer a comprehensive range of departments, including Biochemistry, Hematology, Assay & Hormones, Clinical Pathology, and more. TRUSTlab Diagnostics plans to establish additional centres in the upcoming months, in an effort to ensure that the entire population of India has access to advanced and affordable diagnostic services.

ThermoGenesis to Open a new cGMP Facility in US

ThermoGenesis Holdings, Inc., a market leader in automated cell processing and cell and gene therapy services, announced the grand opening of its new state-of-the-art facility, housing ISO 7 cGMP cleanroom suites, along with research and development labs. The Grand Opening Celebration for the ReadyStart Cleanrooms and IncuStart Wet Labs was held at the facility located at 2890 Kilgore Rd., Rancho Cordova, CA 95670. The state-of-the-art ReadyStart cGMP Cleanrooms and IncuStart Wet Labs will be an incubator facility which will provide the cleanroom environment, equipment, and services needed for R&D and cGMP manufacturing of cell and gene therapies and other life science products. The rollout of the ReadyStart Cleanroom suites is part of ThermoGenesis' previously announced plan to transform from a medical device company to a cell and gene therapy services company and, eventually, a contract development and manufacturing organization (CDMO). The ReadyStart Cleanrooms consist of twelve leasable cGMP compliant ISO 7 cleanroom suites. Each private cGMP suite comes fully equipped and can be configured to meet the client's specific needs. Within the cGMP facility are the IncuStart Wet Labs. The facility will be maintained and supported by ThermoGenesis' operations, quality, regulatory and scientific staff, with more than 25 years of industry experience. "We launched the innovative, flexible ReadyStart cGMP Suites and IncuStart Wet Labs to better support the research and clinical development of cell and gene therapy products. Early-stage life science and cell and gene therapy companies face a long and complex path to product commercialization, often while being constrained by limited budgets," stated Chris Xu, Ph.D., Chairman and Chief Executive Officer of ThermoGenesis. "Our all-encompassing facility will provide a flexible option, enabling companies to achieve their anticipated milestones faster and more efficiently. Additionally, our team's strong expertise in regulatory affairs and product commercialization can help accelerate the development of our customers' products, allowing them to focus on their science, while ThermoGenesis will manage the regulatory and quality compliances associated with running a cGMP facility."

Labstat Announces Expansion into Europe with New Laboratory

Labstat, an industry-leading provider of tobacco/nicotine and cannabis/hemp testing and research services, is excited to announce the opening of a new laboratory in Utrecht, The Netherlands. This marks a crucial step in the expansion of Labstat's global laboratory network, which includes operations in Kitchener, Ontario; Edmonton, Alberta; Knoxville, Tennessee; and Greensboro, North Carolina. "The opening of our Utrecht laboratory signifies an exciting period of growth for Labstat, presenting us with a unique opportunity to extend our top-notch service to our expanding European client base," said Michael Bond, Labstat President. "The new facility allows us to provide superior scientific support locally, meaning shorter turnaround times and more streamlined logistics for our customers." The Utrecht laboratory will commence operations within the next year, focusing on a variety of tobacco/nicotine projects for European customers, offering capacity and readiness to work with clients to scale up testing. "Whether in North America or Europe, our goal is to deliver the same high-quality Labstat service to all our customers," Bond said. "This network expansion not only amplifies our global footprint but also generates new opportunities for our team to help advance scientific excellence in this industry." This European expansion aligns with Labstat's objective to have a broader, positive impact on public health by providing globally reliable and comprehensive nicotine, tobacco, cannabis/hemp, and NHP (natural health products) testing and research services.

CMIC CMO USA and Rutgers University announces partnership, expect to double the jobs at the new facility

CMIC CMO USA Corporation, a subsidiary of Japan’s top contract development and manufacturing organization, CMIC CMO Co., Ltd., and Rutgers, The State University of New Jersey, a renowned institution for research and education, are proud to announce their partnership in advancing the field of Advanced Pharmaceutical Manufacturing. CMIC CMO, a joint venture between DNP Group and CMIC Group, boasts 18 years of industry experience and a global presence with six sites worldwide, including four in Japan, one in South Korea, and one in the US. CMIC CMO USA and Rutgers have agreed to join forces to establish a Center of Excellence in Advanced Pharmaceutical Manufacturing, co-located at CMIC’s 224,000sqf facility in New Jersey. Takahiro Ueda, CEO of CMIC CMO USA Corporation ambitions, “Rutgers brings expertise in advanced and continuous manufacturing, while our suppliers provide the latest technological advances in equipment. This expertise allows us to integrate state-of-the-art infrastructure for rapid product and continuous process development in both non-GMP and GMP environments, giving CMIC unique capabilities to accelerate manufacturing of investigational and commercial products for the benefit of patients around the world”. Makoto Matsukawa, CEO of CMIC CMO, added, “We are very excited about this partnership. CMIC and Rutgers’ shared commitment to innovation and excellence fully aligns with our vision. Together, we can enhance pharmaceutical manufacturing technologies and processes, contributing to the industry’s global advancement.” During the Choose New Jersey Governor-led economic mission to Japan, New Jersey Governor Phil Murphy joined the MOU ceremony between Rutgers and CMIC CMO USA at CMIC headquarters in Tokyo. “Cranbury is already the proud home of CMIC’s operations in North America, and with this new partnership, the company’s economic footprint in New Jersey will only grow in the years to come and is expected to double the number of jobs at the new Cranbury facility in the future,” said Governor Phil Murphy. “This new partnership will put both New Jersey and Japan at the forefront of unlocking the world-changing innovations of tomorrow.”

GordonMD Announces Investment in Radiopharmaceutical Biotech Radionetics Oncology

Craig Gordon, MD, Chief Executive Officer of @GordonMD Global Investments LP, announced that his firm has jointly invested in a private placement financing for Radionetics Oncology. Radionetics Oncology, a clinical stage pharmaceutical company spun out of Crinetics (Nasdaq: CRNX) in 2021, focuses on the discovery and development of novel radiotherapeutics for the treatment of a wide range of oncology indications. GordonMD® joins Frazier Healthcare, 5AM Ventures, and Crinetics Pharmaceuticals as investors in Radionetics. According to commercially available market research reports, the market for radiopharmaceuticals is expected to rise to $12.6 billion by 2027. Radionetics Oncology’s platform technology uses small molecule targeting to deliver radioisotopes to a broad range of cancers by binding selectively to receptors that are overexpressed on tumors. This small molecule technology attempts to address the significant challenges currently facing peptide and protein targeted radiotherapeutics, particularly in the realm of optimizing drug-like characteristics and manufacturing. Radionetics Oncology is advancing a pipeline of novel small molecule radioligands targeting G-protein coupled receptors for the treatment of a broad range of cancers, including adrenocortical carcinoma, breast cancer, and lung cancer. “I believe Radionetics Oncology presents a unique investment opportunity. The company leverages novel targets and the power of radiopharmaceuticals for the treatment of cancer,” said Dr. Gordon, who is also a Board of Directors Observer for Radionetics. “Radionetics just launched an exciting clinical program for adrenocortical carcinoma, which has a high unmet need with no new therapeutics approved since 1970.”

Bayer invests 250 million USD in new cell therapy manufacturing facility in the U.S

Bayer AG has opened a new cell therapy production plant in Berkeley, California, USA, to bring cell therapies to patients on a global scale. The USD 250 million investment will support the production of material required for clinical trials and potential commercial launch of BlueRock Therapeutics’ bemdaneprocel an investigational cell therapy currently in evaluation for treating Parkinson’s Disease. BlueRock Therapeutics LP is a clinical stage cell therapy company and wholly owned, independently operated subsidiary of Bayer AG. The new facility will also support the future production of additional cell therapies as Bayer’s cell therapy portfolio advances. “This new facility ensures our investment in cell therapies can become a reality for patients around the world,” said Stefan Oelrich, member of the Board of Management of Bayer AG and President of the company’s Pharmaceuticals Division. “Cell therapies represent an important opportunity to treat diseases differently by targeting the underlying cause or enabling the human body to restore vital functions.” The new cell therapy facility is part of a transformation at the company’s dedicated biotechnology site in Berkeley, California, where Bayer has invested around USD 500 million over the past five years. “Manufacturing is an important element in taking the biopharmaceutical sector’s pipeline of cell and gene therapies from the laboratory to patients, and this facility enables Bayer to play a critical role in making that happen,” said Holger Weintritt, Member of the Executive Committee of Bayer’s Pharmaceuticals Division and Head of Product Supply of the Pharmaceuticals Division of Bayer AG. “We’re building on our capabilities in manufacturing the most complex protein therapeutics to drive forward platforms that further enable the industry to bring these new medicines to patients worldwide.” Bayer’s global biotech organization supports pharmaceutical innovators to transfer their product candidates from the laboratory bench to patient care. The company’s biotech team provides its biologic development and manufacturing capabilities for Bayer’s larger biotherapeutics portfolio, including commercial products and late-stage protein and cell therapies in development. At the same time the company supports third party companies to enable patient trials and commercial launches through its BioPartnering Solutions offerings. “Having access to this new cell therapy manufacturing facility is important to deliver impactful cell therapies from our development portfolio to patients in need,” said Seth Ettenberg, President and CEO of BlueRock Therapeutics. “Our team is excited to be working shoulder to shoulder with Bayer’s biotech scientists and manufacturing experts as we look to scale up manufacturing for our first investigational therapy, bemdaneprocel for treating Parkinson’s disease, as it advances through clinical trials.”

Lotte Biologics to establish three bio plants, boost local employment

Lotte Biologics has signed a land purchase agreement with the Incheon Free Economic Zone Authority (IFEZ) for the establishment of a Bio Plant in Songdo International City, Incheon, South Korea. Under this land purchase agreement, the company plans to construct three Bio Plants at Block KI20 in Zone 11 (418, 418-9, Songdo-dong, Yeonsu-gu, Incheon) by 2030. Aiming for a total antibody drug production capacity of 360 kL, each plant will be capable of producing 120 kL of antibody drugs. Furthermore, the addition of small-scale bioreactors for clinical material production and Drug Product (DP) facilities is being considered. Plants 1, 2, and 3 are expected to be completed in 2025, 2027, and 2030, respectively, with full-scale operations to begin by 2034, bringing Lotte Biologics' total production capacity to 400 kL. The groundbreaking for Plant 1 is planned for the first quarter of 2024, after finalising preparations such as vendor selection and the remaining review processes, with completion scheduled for the end of 2025. In addition, a 'Bio-Venture Initiative' will be established as part of the Bio Plant complex to support bio-ventures by offering incubation programmes (providing joint laboratories and research equipment), acceleration programmes (technical support in collaboration with global equipment manufacturers, IND filing and commercialisation support in collaboration with accelerator firms, and support for strategic consulting on technology transfers), and support programmes (investment connections, legal and accounting consulting). The company also aims to boost local employment by establishing specialised training programmes for tenant ventures using the company's CDMO capabilities, develop diverse specialised training programmes on CMC document drafting, and creating job opportunities in collaboration with educational institutions in Incheon.

Lonza to expand its Biopharmaceutical capacity, generates 180 new jobs

Lonza, a global manufacturing partner to the pharmaceutical, biotech and nutraceutical markets, announced an extension of a long-term collaboration with a major global biopharmaceutical partner. The extended agreement will increase the current dedicated bioconjugation capacity fourfold by adding two new bioconjugation suites for the commercial supply of ADCs at Lonza's Ibex® Dedicate Biopark in Visp (CH). The extension will occupy 1500m2 of manufacturing space, and will connect to key infrastructure supporting the containment of highly potent drug linkers and the handling of bioconjugates in a highly automated, high-throughput environment. The two dedicated manufacturing areas are expected to comprise one of the largest bioconjugation facilities globally. The new suites are expected to be operational in 2026 and will generate approximately 180 jobs upon completion. The announcement expands Lonza’s current relationship with the customer, through which the company provides highly potent payload, drug-linker, conjugation services, and commercial mAb manufacturing from a single site at Visp (CH). Jean-Christophe Hyvert, President, Biologics, Lonza, commented: “The expansion of this strategic collaboration further validates the concept of Ibex® Solutions and demonstrates our dedication to supporting our partners with operational excellence, specialist expertise and flexible business models. The complete end-to-end ADC ecosystem at our Visp site eliminates supply chain complexities and supports all stages necessary for the manufacture of these highly potent therapies.” Christian Morello, Vice President, Head of Bioconjugates, Lonza, added: “The expanded relationship with our partner builds upon trust and expertise in delivering manufacturing solutions built upon extensive experience in bringing ADC-based therapies to the clinic and beyond. Our relationship with the customer has been evolving to incorporate all stages of bioconjugate manufacturing. This unique journey is a testament to our dedication, expertise, and production capacity, all helping to advance cancer treatment options.”

Freudenberg Medical opens expanded manufacturing facility, creating 100 new jobs in Ireland

Freudenberg Medical, a leading global design and manufacturing partner for minimally invasive medical devices, has announced the creation of 100 new jobs, as it marks the official opening of its newly expanded facility in Galway, Ireland. The newly opened facility increases Freudenberg Medical’s existing manufacturing footprint in Galway by 50% while the newly announced jobs will increase staffing levels by 25%, bringing total staff numbers in Galway to 400 within the next 18 months. The new roles include positions in engineering, research and development, manufacturing operations, quality and support services. The expansion is a strategic move to meet soaring global demand for the company's critical metal components used in minimally invasive surgery catheters. It also positions Freudenberg Medical to develop increasingly complex products to serve its global customer base. Freudenberg Medical employs more than 1,000 people in Ireland, operating from a combined 200,000 sq ft manufacturing footprint at facilities in Galway and Co. Leitrim. Together, its Irish operations manufacture more than 16 million complex catheters each year, serving a global customer base. The company operates sites in key industry hubs across the US, Europe, Asia and Costa Rica. Its Irish facilities were originally established as joint venture partnerships with the former Cambus Medical and VistaMed operations which have now transitioned into Freudenberg Medical.

Cambrex completes expansion of its API manufacturing facility, generates 70 new jobs in Carolina

Cambrex announced the completion of its $38 million capacity expansion at its small molecule active pharmaceutical ingredient (API) manufacturing facility in High Point, North Carolina. This expansion doubles the facility's manufacturing capacity, with new state-of-the-art analytical and chemical development laboratories, two new clinical manufacturing suites, and a small-scale commercial manufacturing operation with three work centers and 2,000 Liter reactors. "When we began this project in 2021, our vision extended far beyond capacity," said Tom Loewald, CEO, Cambrex. "We designed a facility that can continue to deliver on client needs as the industry evolves, with state-of-the-art technology and laboratory equipment, an energy-efficient infrastructure, and clinical to commercial manufacturing scale." The High Point capabilities complement those of previously acquired Snapdragon Chemistry, which specializes in R&D for API batch and continuous flow process development. The combination of Snapdragon Chemistry and the expansion in High Point allows clients to utilize one vendor for flow chemistry scale-up from R&D through commercialization. In addition to the new infrastructure, more than 70 new jobs have been created as Cambrex continues to recruit expert pharmaceutical R&D scientists and staff to the region. Dan Bowles, Vice President and General Manager, Cambrex High Point added, "We are extremely excited about this expansion in North Carolina, which would not have been possible without the support of the State's leadership and economic development programs, and their focus on nurturing the region's skilled and diverse workforce." Cambrex continues to expand its capabilities and capacity across its North American and European network to meet the growing demand for outsourced product development and manufacturing services.