Issue link: https://www.e-digitaleditions.com/i/1521797
News about companies that support development of orally inhaled and nasal drug products (OINDPs), including regulatory approvals, new partnerships, new products and services, and results of clinical studies. 8 June 2024 Inhalation patients should not have to bear the responsibility of environ- mental impact when consider- ing treatment options that affect their health," explained Giuseppe Accogli, CEO. "We are dedicated to developing inhalers that meet patient needs while minimizing environmental impact." Scherdel Medtec NA achieves ISO 13485:2016 certification MUSKEGON, MICHIGAN, US—Scherdel Medtec North America, part of Scherdel Med- tec GmbH, which provides high- precision medical device components—including compo- nents for inhalers—announced it has achieved certification to the ISO 13485:2016 standard. "We are confident that ISO 13485 certifica- tion will provide several key bene- fits for our customer and Scherdel Medtec NA," said Drew Jelgerhuis, Business Development Manager. ose benefits include a stronger foundation for continued growth in North America; enhanced cus- tomer confidence and a com- mitment to quality and safety; expanded market access to meet the growing requirements of drug, device, and contract manufactur- ers; risk reduction to identify and mitigate potential risks before they impact medical devices; improved efficiency including reduced waste to increase productivity and increased employee engagement leading to improved performance. Nebu-Flow secures additional investment GLASGOW, UNITED KING- DOM—According to Business Wire, Nebu-Flow has secured an additional $5.9 million of invest- ment to accelerate its development of the next generation of inhaled drugs for patients with respiratory disorders. e funding round was led by SCVC, a UK-based ven- ture capital firm that invests in early-stage deep-tech spinoffs, and was supported by Scottish Enter- prise, Foresight WAE Technology, Renaissance Lakewood opens new headquarters LAKEWOOD, NEW JERSEY, US—Renaissance Lakewood, LLC announced the official open- ing of their new headquarters in Lakewood, New Jersey, US. e multi-million-dollar expansion and facilities upgrade began in 2020 and consists of two new build- ings, as well as the renovation of the company's former headquar- ters building. e new headquar- ters will "dramatically increase" Renaissance Lakewood's GMP warehouse square footage and serve as the primary client engagement and administrative hub for the company. e office space portion of the building is now fully occu- pied and the warehouse is expected to be online by third quarter of this year. "Creating an environment where our clients feel welcome and supported is of paramount impor- tance to us as a CDMO," noted Serge Maltais, President and CEO. Chiesi begins Phase III trial of carbon- minimal inhaler PARMA, ITALY—Chiesi Group announced it has started a long- term, Phase III clinical safety trial of its carbon-minimal inhalers platform, replacing the current hydrofluorocarbon propellant (HFC-134a) with the low global warming (LGW) potential pro- pellant (HFC-152a). A company news release stated that Chiesi "already completed two short- term clinical trials assessing the safety of the new propellant, plus three clinical pharmacology stud- ies on the carbon- minimal, fixed combination of an inhaled cor- ticosteroid (ICS) and a long-act- ing bronchodilator (LABA)." ose studies "have collectively provided reassuring evidence of similar performance and toler- ability of the new formulation," when compared to the current [formulation], for patients with asthma and chronic obstructive pulmonary disease (COPD). "At Chiesi, we strongly believe that INDUSTRY NEWS Bespak and H&T Presspart to collaborate on low GWP pMDIs HOLMES CHAPEL, UK, AND BL ACK BUR N, UK—Bespak and H&T Presspart announced a collaboration to accelerate the industry's transition from existing pressurized metered dose inhaler (pMDI) formulations to more climate- friendly alternatives uti- lizing low global warming (GWP) potential propellants. e partner- ship will provide rapid access to small-scale filling capabilities in GMP conditions to support devel- opment programs and clinical trials with both HFA-152a and HFO- 1234ze propellants. "We believe in working together across the indus- try to achieve this goal—which not only helps protect the planet, but also safeguards patient access to inhaler options," said Chris Hirst, CEO, Bespak. "is collab- oration underlines [our] core stra- tegic commitment to support the industry in creating more sustain- able inhalation products for future generations," commented Christian Krätzig, President, H&T Presspart. Lonza expands offering for spray-dried biologics BASEL , SW ITZER L A ND — Lonza announced an expansion of its services for spray drying of proteins for pulmonary delivery. Its new offering will provide man- ufacturing of spray-dried protein formulations, nucleotide-based drugs and peptides for clinical and commercial supply, at a kilogram scale, for bioavailability enhance- ment and inhaled delivery, from its Center of Excellence in Bend, Oregon, US. "Pulmonary delivery of solid protein formulations using a dry powder inhaler is a growing trend among drug developers," said Kimberly Shepard, Director, Respiratory Delivery. "Our new clinical offering [can] enable our customers to bring innovative new medicines to patients with unmet medical needs." continued on page 35