BUSINESS INSIGHTS, PHARMA TECH
US Pharmacopeia | January 04, 2023
The United States Pharmacopeia (USP) has announced the launch of the USP Advanced Manufacturing Technology Lab in Richmond, Virginia, as a part of its launch of a suite of R&D analytical solutions. These analytical lab services will aid drug manufacturers in adopting advanced manufacturing technologies, such as pharmaceutical continuous manufacturing (PCM), to increase geographic diversity in pharmaceutical manufacturing and support medicine supply chain resilience.
The new R&D analytical solutions will include analytical lab services that take advantage of USP's in-house scientific expertise and cutting-edge facilities at the USP Advanced Manufacturing Technology Lab in Richmond, as well as its headquarters in Rockville, Maryland. These capabilities will be utilized to characterize materials and qualify and develop ways to help ensure the quality of PCM-based medicines.
PCM involves a continuous flow of materials through a process pipeline in which two or more unit operations are directly connected and the sequential transformation of those materials. As the input materials are fed in, the process output, such as an active pharmaceutical ingredient or drug product, is collected, and the complete procedure is carried out in a single facility.
USP's emphasis on R&D analytical solutions and PCM-specific quality assessments is part of a broader set of activities aimed at addressing the problems of PCM adoption and bolstering pharmaceuticals' supply chain resilience.
Consulting services provided by a USP company, Pharmatech Associates, Inc., can assist manufacturers with decision-making and problems associated with PCM adoption. Pharmatech Associates consulting services, which operate independently of USP's standards-setting processes, provide manufacturers interested in PCM and other advanced manufacturing technologies with technical, business, and regulatory strategies, workforce training, and equipment and process design.
About The U.S. Pharmacopeia (USP)
USP is a non-profit, independent scientific organization that provides safe, high-quality pharmaceuticals. The organization has strived to establish confidence in the world's drugs, dietary supplements, and foods for more than two centuries. It protects patient safety and enhances global health via rigorous science and the establishment of public quality standards.
BUSINESS INSIGHTS, PHARMACY MARKET
PRNewswire | March 23, 2023
Hovione and Laxxon Medical announced a strategic collaboration to advance the use of 3D screen printing technologies for the pharmaceutical industry. This partnership combines Laxxon´s expertise in 3D screen printing, based on their SPID®-Technology, with Hovione's product & process development, engineering and manufacturing expertise in pharmaceutical applications. Under the terms of the agreement, Hovione will establish the Laxxon Medical 3D screen printing technology at Hovione's cGMP production sites first in Portugal and later in the USA.
The 3D technology displays numerous advantages including the potential to produce unique or customized dosage forms with characteristics that cannot be achieved with conventional dosage forms, the ability to create tablets of any shape and size, the option to easily adjust the number of active substances and individual components in the composition of the tablet and even to set the dosage individually for each patient for personalized medicines.
"Laxxon is thrilled to establish a long-term partnership with Hovione." said Klaus Kuehne, COO of Laxxon Medical. "This partnership will serve as a great accelerator in establishing 3D screen printing within the pharmaceutical industry thus accelerating our ability to serve our customers." "Hovione has a global reputation for their pharmaceutical innovation services, expertise and market access. This agreement marks a significant milestone for Laxxon in terms of our own market strategy and development efforts." said Helmut Kerschbaumer, Laxxon's CEO. "We are looking forward to collaborating with Hovione to promote innovation through 3D screen printing."
"We find the Laxxon Medical 3D printing technology to be very innovative and enabling. It not only allows for the customization and production of drug products with complex shapes and structures as well as unique API release characteristics but it also has the potential to reduce the time and cost of drug development" says Dr. Jean-Luc Herbeaux, Hovione´s CEO. He adds "Hovione has a track record of turning emerging pharmaceutical production technologies into reliable and scalable offerings at both developmental and commercial scales. We are excited at the prospect of supporting Laxxon in industrializing its 3D printing technology and make it accessible to a greater number of pharmaceutical and medical device companies."
With this partnership the platform will be available from early development phases to routine commercial manufacturing.
Hovione is an international company with over 60 years of experience in pharmaceutical development and manufacturing operations. As a Contract Development and Manufacturing Organization (CDMO) Hovione has a fully integrated offering of services for drug substance, drug product intermediate and drug product. The company has four FDA inspected sites in the USA, Portugal, Ireland and China and development laboratories in Lisbon, Portugal and New Jersey, USA. Hovione provides pharmaceutical customers services for the development and compliant manufacture of innovative drugs, including highly potent compounds, and customized product solutions across the entire drug life cycle. In the inhalation area, Hovione offers a complete range of services, from API, formulation development and devices. Hovione´s culture is based on innovation, quality and delivery. Hovione was the first Chemical/ Pharmaceutical Company to become a Certified B Corp, is a member of Rx-360, EFCG and participates actively in industry quality improvement initiatives to lead new global industry standards.
RESEARCH, PHARMA TECH
OM1 | February 06, 2023
OM1, a leading real-world data, results, and technology firm focused on chronic diseases, recently announced the release of its Reasons for Discontinuation (RfD) Analytic Reports. Utilizing the OM1 Real-World Data CloudTM, Immunology Real-World Data Network, and proprietary artificial intelligence (AI) technology, the RfD reports provide difficult-to-obtain, extremely valuable discontinuation trends for cDMARDs, bDMARDs, and tsDMARDs in primary dermatologic and rheumatologic conditions.
Each year, millions of Americans cease their prescriptions prematurely, costing the pharmaceutical industry in the United States an estimated $250 billion in lost income and can affect the health of these patients. Therefore, it is crucial for pharmaceutical businesses to comprehend patient discontinuation patterns so they may act on information regarding tolerability, costs, and emerging contraindications to enhance the patient experience. Prior to this point, it was extremely difficult to extract these insights due to the fact that crucial information was not reflected in claims or any other sort of structured data but was only available in clinical notes.
OM1 is elevating the clinical narrative into actionable insights that pharmaceutical companies can rely on to comprehend patient adherence and clinician prescribing behavior, thanks to its data cloud built on billions of data points from over 300 million patients and unique AI and modeling capabilities. The analyses, which are conducted across multiple strata, such as demographic groups, patient characteristics, medical histories, comorbidities and care pathways, extract insights from the extensive clinical data sets available to OM1 and notes from prescribing clinicians dating back to 2013.
Currently, accessible RfD reports include psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis, psoriasis, and atopic dermatitis, with more to come, including schizophrenia, depression, and bipolar illness.
Founded in 2015, OM1 is a renowned health outcomes, and registries firm focused on treatment outcome measurement, comparison, and prediction. OM1 created the first intelligent data cloud for healthcare, leveraging big data, standardized outcomes measurement, and artificial intelligence technologies to provide more precise information and improve decision-making for stakeholders across the healthcare ecosystem. The company is reimagining real-world data and evidence in immunology, cardiometabolic, mental health and neurosciences, respiratory and ENT specialty areas by establishing vast electronically connected networks of clinicians and health data.