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
Businesswire | April 24, 2023
PCI Pharma Services a leading global contract development and manufacturing organization announced that three new state-of-the-art automated sterile fill-finish machines at its San Diego and Melbourne facilities are now fully operational. The innovative machinery from Cytiva can be used to fill various sterile medications into vials and syringes for small-to-mid scale client needs. The equipment, paired with PCI’s end-to-end services, accelerates Speed to Study™, and drastically decreases the average turnaround time from proposal signing to the injectable product’s distribution.
“As the capacity for CDMOs worldwide to take on new projects shrinks, we’re excited to be able to offer integrated sterile fill-finish capabilities, alongside our clinical packaging facilities, to new and existing clients in Melbourne and San Diego,” said Brad Payne, Chief Operating Officer, PCI Pharma Services. “Our increased capacity, stockpile of standardized components, including glass, and technical expertise means we can start running batches as soon as needed. This will cut down on the wait times many pharmaceutical companies are facing and begin to help alleviate the global capacity shortage for sterile drug product and downstream packaging.”
The Microcell Vial Filler and SA25 Aseptic Filling Workcell at PCI’s San Diego facility ensures the delivery of medicines from phase I through phase III, supporting local and global Clinical client needs. Additionally, a Microcell Vial Filler at Melbourne further enhances the early-stage services offered and brings additional capacity to Australia—the world’s leading phase I environment. These advanced machines expedite the filling process with automation and remove the need for human intervention in a sterile environment, creating compliance advantages over standard equipment.
“There are less barriers to entry to start a clinical trial in Australia, as well as significant cost benefits, and with Melbourne being an especially popular place to conduct phase I trials, we knew we needed to bring this capability and added capacity to the local market,” said Tim Roberts, Chief Commercial Officer, PCI Pharma Services. “In addition, we are then able to take our clients through their lifecycle journeys with the expansions and advanced capabilities in our New Hampshire and Madison campuses. With successful recent inspections at our Bedford facility by the Brazilian (ANVISA) and Japanese (PDMA) regulatory authorities, our global reach to supply life-changing therapies to patients quickly and safely is wider than before.”
To better support its clients throughout the world, PCI has also recently invested in expansions in Rockford, IL, and Tredegar, Wales, as well as established new facilities in Bedford, NH, and Bridgewater, MA.
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 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 4,300 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.
VIEWS AND ANALYSIS
Businesswire | May 05, 2023
Harrow a leading U.S. eyecare pharmaceutical company, announced the completion of the transfer to Harrow of the New Drug Applications (NDAs) for ILEVRO® (nepafenac ophthalmic suspension) 0.3%, NEVANAC® (nepafenac ophthalmic suspension) 0.1%, and MAXIDEX® (dexamethasone ophthalmic suspension) 0.1%. These three FDA-approved ophthalmic medicines, which are now commercially available under the Harrow umbrella, were among the five products that Harrow purchased in January of 2023 and for which Harrow has been receiving net profits from unit sales during the NDA transfer process. Harrow expects to complete the transfer of the NDAs for the two remaining products, VIGAMOX® (moxifloxacin hydrochloride ophthalmic solution) 0.5% and TRIESENCE® 40 mg/ml, by year-end.
“We are delighted to have completed the NDA transfer process for ILEVRO, NEVANAC, and MAXIDEX earlier than our originally estimated six-month period,” said Mark L. Baum, Chief Executive Officer of Harrow. “We can now implement our market access, marketing, inventory management, and national sales detailing strategies for each of these three products, and we expect to extend those efforts when the NDAs for the remaining two products, VIGAMOX and TRIESENCE, are transferred later this year.
“Our market research has shown that the market need for all five of these products continues to increase with U.S. demographic growth and that there are few, if any, new competitive threats, particularly in the NSAID market. These products are used during procedures and within markets in which Harrow already has a strong foothold, and we look forward to making these well-known and valuable ophthalmic medicines available to the eyecare professionals that we serve nationwide as we continue to execute our branded ophthalmic pharmaceuticals market strategy.”
Product orders for ILEVRO, NEVANAC, and MAXIDEX can be made directly through Harrow’s dedicated customer service ordering partner, Cardinal’s Cordlogistics, which includes a wholesaler distribution system encompassing McKesson and AmerisourceBergen.
Harrow is a leading U.S. eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic prescription therapies that are accessible and affordable. Harrow owns U.S. commercial rights to ten FDA-approved ophthalmic pharmaceutical products. Harrow also owns and operates ImprimisRx, the leading U.S. ophthalmic‑focused pharmaceutical compounding business, which also serves as a mail-order pharmacy licensed to ship prescription medications in all 50 states. Harrow has non-controlling equity positions in Surface Ophthalmics, Inc. and Melt Pharmaceuticals, Inc., companies that began as subsidiaries of Harrow. Harrow also owns royalty rights in four late-stage drug candidates being developed by Surface and Melt.