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Article / Jun 17, 2016

Quality Culture Wins Over Compliance

Pharma's Almanac, June 2016

The author (Guy Villax) presents his views about the latest update of FDA's guidance which includes quality culture.

It’s Official! FDA has introduced Quality Culture in its guidance – although still in draft, it signals a sea change at the agency. No longer will FDA focus solely on compliance. Pharmaceutical manufacturers will be recognized for excellent performance. Pharma companies that rely on contract service providers will be able to use Quality Metrics and New Inspection Protocol Project (NIPP) performance scoring to make better decisions when it comes to selecting CDMOs.

Read Quality Culture Wins Over Compliance.

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Hovione is a global contract development and manufacturing organization (CDMO) company founded in Portugal in 1959. With approximately 2,400 team members worldwide, the company provides comprehensive services for drug substances, drug intermediates, and drug products in countries around the world. Japan in particular plays a very important role in Hovione's global strategy, and in 2017 it established a Japanese subsidiary in Osaka. The company plans to actively invest in further strengthening its organization and recruiting personnel. With development labs strategically located in Lisbon, Portugal, and New Jersey, USA, Hovione consistently provides superior solutions tailored to complex pharmaceutical challenges. Hovione is recognized globally for its scientific excellence, technological innovation, and customer-centric and integrated approach. Leveraging cutting-edge capabilities in chemical synthesis, particle engineering, and formulation development, the company supports its partners throughout the entire pharmaceutical life cycle.   Read the full article in Japanese Read the article translated in English   Visit the Yakuji Nippo online      

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The global inhalation contract development and manufacturing organization (CDMO) market is projected to grow from USD 9.13 billion in 2025 to USD 16.68 billion by 2035, reflecting a compound annual growth rate (CAGR) of 5.7% during the forecast period. This growth is driven by the increasing prevalence of respiratory diseases, advancements in inhalation drug delivery technologies, and the rising demand for outsourced manufacturing services in the pharmaceutical industry. The inhalation CDMO market has emerged as a pivotal segment in the pharmaceutical contract development and manufacturing industry. With a rising demand for inhaled therapies for conditions like asthma, COPD, and cystic fibrosis, companies are increasingly outsourcing drug development and production to specialized partners. Inhalation CDMO services cater to both large pharmaceutical corporations and small biotech firms, offering expertise in formulation, device compatibility, regulatory support, and scale-up manufacturing. This market is gaining traction due to the complexity of inhalation drug delivery, which often requires niche technical capabilities and specialized equipment. Outsourcing to an inhalation CDMO allows drug developers to reduce time-to-market while ensuring quality and compliance with global standards. (...) Top Companies Several players dominate the inhalation CDMO market through technological expertise, global reach, and service portfolio diversity: (...) Hovione – Offers particle engineering and inhalation development, with a focus on dry powder inhalers. (...) These companies are continually investing in facilities, talent, and technology to meet evolving customer needs in the inhalation CDMO market.   Read the full article on Pharmiweb.com        

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CDMO Hovione and biotechnology company Firstgene Life Sciences (of Xlife Sciences) have collaborated to advance Hovione’s drug delivery platform for the targeted treatment of Hepatocellular Carcinoma (HCC). “We are proud to advance the development of innovative oncology treatments that address a critical unmet need for precision gene expression at the tissue level,” said Hovione CEO Dr Jean-Luc Herbeaux. The virus-like particle technology will be engineered and functionalised for the specific carcinoma cell type using therapeutically validated AAVs, including a novel primer compound. Hovione will be responsible for molecular engineering, the supply of tailor-made virus-like particles and the execution of proof-of-concept studies. “HCC, the most common liver cancer and a leading cause of cancer-related death, continues to represent a major unmet medical need,” said Firstgene managing director Dr Alexander Zink. “The combination of Hovione’s expertise in complex chemistry and particle engineering and the commercialisation expertise of Xlife Sciences positions Firstgene well to offer patients potential new safe and effective therapy options.”   Read the full article at scientistlive.com    

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