Businesswire | June 02, 2023
REALM IDx announced the launch of REALM Pharma Services, an end-to-end discovery, translational research, and clinical trial service for biotechnology and pharmaceutical partners. Through a strategic integration, REALM Pharma Services brings together the research arms of subsidiaries, Ambry Genetics and Invicro, to offer cutting-edge genomics, traditional and molecular pathology, and advanced imaging and spatial biology. Combined with machine learning and artificial intelligence (AI) from REALM’s informatics organization, the company believes this end-to-end service can help reveal new insights and develop multi-dimensional models for drug discovery and validation.
“We are excited to offer a comprehensive multiomic and multimodal program that has been tailored to support the needs of our biopharma partners,” said Aaron Elliott, PhD, CEO of REALM IDx. “We believe the integrated approach offered through REALM Pharma Services is a transformative shift in research and will bring new, data-driven insights to precision medicine.”
Use of advanced omics, including single-cell omics, is increasingly being incorporated by biopharma into discovery and research efforts, particularly in the field of cancer. This approach can support improved understanding of biological complexity in immuno-oncology and a system-wide path to drug efficacy. However, a significant challenge has been the lack of a consolidated infrastructure to not only support analytical testing and data collection, but also computational analysis of unique data sets to find novel associations for translational insights.
“In supporting our biopharma partners, we see ourselves as a powerful connecting force,” said Jonathan Usuaka, PhD, Chief Strategy and Informatics Officer for REALM IDx. “Along with world-class genomics, pathology, spatial imaging and analysis services, we support real-world data and advanced analytics to inform drug development at every stage.”
The company will introduce REALM Pharma Services while exhibiting at the upcoming American Society of Clinical Oncology annual conference in Chicago, June 3 – 5. While at the conference, the company will also share details of a new comprehensive genomic profiling test (CGP) for cancer developed in collaboration with its partners in Japan and set to launch this summer. Additional information about REALM Pharma Services may be found on REALM’s website.
About REALM IDx
REALM IDx, Inc. is a health care company pioneering in the field of Integrated Diagnostics (IDx), an advanced field of clinical science that brings together laboratory medicine, radiology, pathology and sophisticated artificial intelligence to derive actionable insights to predict, diagnose and treat disease. Powered by proprietary software platforms, industry-leading genomics technology from Ambry Genetics Corporation and radiology and pathology services from Invicro, LLC, the company is equipped to collect, analyze and report on multi-modal precision diagnostic data sets.
BUSINESS INSIGHTS, PHARMACY MARKET
Businesswire | May 10, 2023
AustinPx, a contract development and manufacturing organization (CDMO) specializing in analytical and formulation development services and cGMP manufacturing for small molecule drugs, today announced the expansion of its capabilities to meet industry demand for the Company’s services and expertise. The Company has added new spray drying and encapsulation capabilities and has also expanded its GMP manufacturing capacity for high shear and fluid bed granulation.
AustinPx has installed and validated a Dott. Bonapace INCAP capsule filler, a Freund-Vector VFC3 model fluid bed, and a Freund-Vector GMXB-Pilot model granulator. The INCAP rounds out the Company’s solid dose manufacturing capabilities, while the fluid bed and granulator supplement the Company’s manufacturing scale.
“The investments are a key component of AustinPx’s larger strategy to expand our oral dose development and manufacturing capabilities to better serve our clients’ increasing demand,” said Justin Keen, PhD, senior vice president operations. “The additions demonstrate our ongoing commitment to providing our clients with the best possible service and support."
In line with the Company’s mission of providing science-driven formulation development, AustinPx has installed a PROCEPT modular 4M8-Trix for the development of spray dried amorphous solid dispersions. The addition supplements AustinPx’s current portfolio of bioavailability enhancement technologies, including KinetiSol® Technology - the Company’s proprietary fusion-based amorphous dispersion manufacturing platform.
“We are excited to add spray drying to our portfolio,” said Dave Miller, PhD, chief scientific officer. “When combined with our existing formulation capabilities, the addition enables us to provide a comprehensive suite of bioavailability enhancement solutions to identify the optimal formulation pathway for poorly soluble compounds and address a greater number of our clients’ challenges.”
The expanded capabilities are now available for use. These additions are the first of several strategic investments planned for the Company in the immediate future, as AustinPx continues to position itself as a leading CDMO in the pharmaceutical industry.
AustinPx, Pharmaceutics and Manufacturing, is a contract development and manufacturing organization (CDMO) providing analytical and formulation development services and cGMP manufacturing for small molecule drugs. We specialize in phase-appropriate development strategies, speed to clinic and market strategies, and bioavailability enhancement of poorly soluble molecules - including our next generation amorphous dispersion platform, KinetiSol® Technology.
BUSINESS INSIGHTS, PHARMACY MARKET
PCI Pharma Services | March 20, 2023
PCI Pharma Services (PCI), a leading global contract development and manufacturing organization (CDMO), announced plans for a new 200,000-square-foot facility in Rockford, Illinois to enhance the organization’s capacity in injectable drug-device combination product assembly of both biologics and small molecules. Building on PCI’s leadership in this space with its Philadelphia Biotech Center of Excellence, the new facility is the second expansion building off the success in Philadelphia and will house over 20 dedicated customer suites with multiformat machines for the assembly and packaging of vials, pre-filled syringes, auto-injectors, and pen-cartridge combinations. This machinery can be used for the glucagon-like peptide 1 agonists (GLP-1) class of drugs prescribed to treat diabetes and obesity, as well as those needed for oncology treatment and autoimmune diseases.
PCI’s Rockford location will have extensive product testing capability, state-of-the art top-load cartoning technology, and industry leading injector and pen assembly equipment. Additional capabilities include on-site cold storage, high-speed vial labeling, assembly, and packaging of multiformat autoinjectors, serialization, testing, and drug product release.
“We see the tremendous impact that we can make with patients with this investment,” said Salim Haffar, CEO of PCI Pharma Services. “The need for injectable drug-delivery device combination product capacity and expertise is critical, and we are responding with a world-class facility to address the future demands of our global clients so they can focus on developing therapies to improve the lives of patients with serious chronic conditions.”
The $50 million investment in Rockford will amplify PCI’s specialty drug leadership presence in the Midwest, adding to clinical and commercial sterile fill-finish capabilities in Madison, Wisconsin. The new facility will provide a second hub within the U.S., expanding from PCI’s foundation in the Northeast, with Bedford, New Hampshire’s campus growth in aseptic processing. PCI also has sterile fill-finish capabilities at its Leon, Spain; San Diego, California; and Melbourne, Australia locations. The expansion in Rockford is expected to bring 250 jobs to the region in the next two years, with continued growth over three to five years. The site is expected to be fully operational in summer 2024.
“With this new facility, we will be able to serve all clients focused on injectable drug products including biologics with the equipment and capacity to make life-changing medicines,” said Gil Valadez, Senior Vice President, Commercial Packaging Technology, PCI Pharma Services. “We want to help our clients by managing the technical aspects of drug manufacturing, engineering, and delivery, so they can focus on what’s most important: delivering quality products to meet patient needs. That's what PCI is ultimately all about.”
About the Rockford, IL Facility
Rockford is the largest of PCI’s 30 locations across the U.S., European, and Asia Pacific regions, providing industry-leading services for the clinical and commercial packaging of a diverse portfolio of products and specialized delivery forms destined to reach more than 100 countries across the world. The gated secured facility is classified by the Drug Enforcement Administration (DEA) as Schedule 3. It features temperature and humidity control, an approved Foreign Trade Zone (FTZ) and offers TF1 and Uhlmann blistering, vibratory and slat filler bottling, powder filling, cartoning, carding, kitting and serialization capabilities. Warehouse storage includes freezer storage -15°C to -30°C and cold storage 2°C to 8°C.
About PCI Pharma Services
PCI is a leading global CDMO, providing clients with integrated end-to-end drug development, manufacturing and packaging capabilities that increase their products’ speed to market and opportunities for commercial success. PCI brings the proven experience that comes with more than 50 successful product launches each year and over five decades in the healthcare services business. We currently have 30 sites across seven countries (Australia, Canada, U.S., Ireland, Wales, Germany and Spain) and over 5,000 employees that work to bring life-changing therapies to patients. Leading technology and continued investment enable us to address global drug development needs throughout the entire product life cycle – from manufacturing capabilities through the clinical trial supply chain and into commercialization. Our clients view us as an extension of their business and a collaborative partner with the shared goal of improving patients’ lives.