Manufacturing roundup: Lonza completes manufacturing facility in Eastern Oregon; Walmart and CVS part of massive Covid vaccine dump — report

2022-06-09

疫苗小分子药物

While Bend, Oregon is more known for its outdoor amenities and the last remaining Blockbuster Video store, Swiss manufacturing company Lonza has expanded its presence in the area. The expanded facility, called the Early Phase Clinical Manufacturing facility, has added a new facility to its small molecules site that also serves as the company’s center of excellence for bioavailability enhancement and inhaled delivery for its small molecules business unit. The new multimillion-dollar, 13,000-square-foot facility now provides additional capacity for solutions to complex bioavailability challenges in clinical projects and contains seven GMP processing suites. Jason Bertola, the executive director of commercial development at Lonza, said in an email to Endpoints News that the expanded facility will support the early clinical phase development and manufacturing capabilities of particle-engineered intermediates and finished oral drug products. “The early stages of drug development are critical to our business, and we continue to observe strong demand from customers. These fit-for-purpose suites are designed to rapidly advance challenging molecules. The facility is now open and includes spray drying dispersion, dry granulation and a tablet press,” Bertola said. According to Lonza, additional developments are already underway. Toward the end of the year, Lonza anticipates adding a second spray dryer specifically designed for the manufacturing of engineered particles for inhalation as well as encapsulation equipment for encapsulated drug products. Lonza has been strengthening its capabilities recently, expanding its API development and manufacturing labs at a site in Nansha, China last year. Oasmia Pharmaceutical has inked a deal with Lonza to manufacture its ovarian cancer drug candidate Cantrixil there. Also in 2021 , the company laid out a $935 million outlay to build new sites in Visp, Switzerland and Portsmouth, NH, to help grow the company’s biologics portfolio. According to a report from NBC News, pharmacies, US territories and federal agencies wasted 82.1 million vaccine doses from December 2020 through mid-May. The leading culprits were the retail pharmacy chains CVS and Walmart, who were responsible for over a quarter of the doses thrown away in the country in that period, mainly due to the large volume of vaccines they received, according to the NBC report. Other major players that have tossed their vaccines include Health Mart, DaVita, Rite Aid, Publix and Costco. This is not the first time a large batch of vaccine doses has been tossed, as a report detailed in early May that the manufacturer Emergent had to destroy over 400 million doses due to a failure of quality standards at their plant in Maryland. In May , Switzerland announced they were destroying 600,000 doses of Moderna’s Spikevax Covid-19 vaccine Covid-19 vaccine as the doses have reached their expiration date. England and Denmark have had to toss over 6.6 million doses combined due to expiration dates hitting or donation efforts failing. The UK-based manufacturer SMC has opened the doors of a new facility in Cambridge, UK. Cambridge Pharma, a subsidiary of SMC and Oval Medical Technologies, is now open to offering pharmaceutical development services. Their new 20,000-square-foot facility at the Cambridge Research Park includes a purpose-built sterile fill-finish facility, a process development laboratory and an analytical laboratory. Services at the facility will include process development and scale-up, sterile fill-finish for clinical trials, QC and stability testing, and QP release of the clinical trial process. “We value pharmaceutical partnerships and continue to expand services in development, manufacturing and analytical testing to help accelerate drug product development,” SMC Group CEO Chetan Patel said in a statement. The company’s sterile fill-finish facility contains two clean rooms designed to support batch sizes from 100 units to 15,000 units in vials, cartridges or syringes. Cambridge Pharma is designed to take a customer’s laboratory-scale formulation and develop a process for clinical trials in Phases I to III, including process development and filling of viscous formulations, suspensions and gels.