Press Room

Event

Webinar - Practical Management of Pharmaceutical Impurities

Start
Wednesday, July 15, 2020 - 16:00
End
Wednesday, July 15, 2020 - 17:00
Location: online
Drug Substance pharmaceutical industry | Hovione

Wednesday, July 15th, 2020  |  11 am (EDT) / 4 pm (BST) / 5 pm (CEST)

 

Watch On-Demand Webinar

 

Speakers
Marco Galésio - Analytical Chemist
Daniel Pereira - Analytical Chemist

 

The management and control of pharmaceutical impurities is a matter of great concern and is an important part of drug development and regulatory assessment. Current regulations and guidelines demand a comprehensive understanding of the impurity profile of pharmaceutical products, as their safety and quality can be impacted by the presence of impurities. The nature and the quantity of impurities is affected by different factors, including synthetic route of the drug substance, quality of the starting raw materials, reagents, solvents, excipients, packaging and storage of the final product.

The ICH quality guidelines ICH Q3A and Q3B address questions related to the regulation of impurities in the drug substance and drug product, whereas other ICH quality guidelines address specific types of impurities, such as residual solvents and genotoxic impurities.

With this webinar we pretend to look at the different sorts of impurities that may occur in pharmaceutical products and discuss current regulations, requirements and control strategies to be followed in order to comply with the current demands.

Learning objectives

  1. General pharmaceutical impurities management and control
  2. Control of Residual Solvent, ICH Q3C
  3. Control of Elemental Impurities, ICH Q3D
  4. Control of Genotoxic Impurities, ICH M7

Watch On-Demand Webinar

 

 

Also in the Press Room

See All

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      

Press Clipping
Yakuji Nippo Magazine, 2 July 2025

Solving Complex Pharmaceutical Challenges

Jul 10, 2025

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        

Press Clipping
Pharmiweb.com, 25 June 2025

Inhalation CDMO Market Growth Analysis & Forecast 2025 to 2035

Jun 25, 2025

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    

Press Clipping
Scientist Live, 12 May 2025

Partnership advances liver cancer treatment

May 12, 2025

Also in Events

See All