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With four FDA inspected sites in the USA, China, Ireland and Portugal and development laboratories in Lisbon, Portugal and New Jersey, USA, the company provides branded pharmaceutical customers services for the development and compliant manufacture of innovative drugs including highly potent compounds. For generic pharmaceutical customers the company offers niche API products. Hovione also provides proprietary product development and licensing opportunities for drug products. In the inhalation area, Hovione is the only independent company offering a complete range of services.
3 primary service lines
- Contract manufacturing services
- Generic API products
- Proprietary drug product licensing
Contract Manufacturing Services
Our aim is to meet customer needs across products and services that require the very highest standards of manufacturing quality and technical performance.
Particle Engineering
We specialize in particle engineering technologies to address oral bioavailability, lung delivery, modified release and taste masking. In each technology, we can support you from proof of concept to commercial manufacturing.
Having been involved in over 100 scale-up projects, Hovione has unrivaled experience in the industrialization and manufacturing of processes that use spray drying technologies. To date, we have successfully supported numerous process validations and regulatory submissions with subsequent marketing authorizations.
Hovione performs: a) proof of concept studies using the absolute minimal quantities of the drug substance b) full process industrialization and c) commercialization. Our development tools are constantly evolving to provide an enhanced understanding of the product and process. Some of our tools include mechanistic modeling, scale-up science, statistical design of experiments, respective analysis and process analytical technologies (PAT).
Our Particle Engineering manufacturing assets are spread over three sites (Cork, Loures, New Jersey) and range from pilot to very large scale equipment. Hovione has also invested in capacity to handle highly potent compounds at our Loures and New Jersey sites in response to the increasing number of highly potent drugs under development and requests from customers. Our spray drying facilities are inspected and approved by all major regulatory authorities and audited by more than 30 clients a year. We can ship your Drug Product Intermediate anywhere you wish or continue downstream processing at our Drug Product facility.
Hovione has been at forefront of the application of Quality by Design methodology as well as Lean Manufacturing principles to drive efficiency in manufacturing processes. Step-change improvements in lead-times have also been achieved through detailed analysis of the product value chains, through elimination of redundant activities and focus on rate-limiting steps.
As an integrated service provider Hovione can manufacture your drug substance all the way to commercial supplies and perform formulation development and production of early clinical supplies.
Innovation and Expertise in Inhalation Drug Development
Your trusted partner for inhalation drug development.
Our experience in inhalation products started with corticosteroid APIs, which we have been manufacturing for the past fifty years. With a view to helping customers solve complex problems we have invested in building know-how and expertise in particle design and formulation development for highly sophisticated inhalation APIs.
Over the past twenty years Hovione has developed key expertise in inhaler development, leading to the market approval and introduction of the TwinCaps® inhaler, the only market approved single use disposable inhaler.
Key Particle Engineering Technology Development
We can tailor-make particle size distributions through complex particle engineering technologies, like wet-polishing and monosep, in ranges suitable for inhalation and incorporate desired morphology characteristics into your API. We are also able to start with a Hovione-produced API and develop a dry powder formulation to meet your inhalation product development demands.
Key Technical Capabilities
- Particle size reduction
- Particle engineering technologies – (jet milling, wet polishing, microencapsulation, monosep, nanomilling and others)
- Cascade impaction (Fast Screening Impactor, Andersen Cascade Impactor and Next Generation Impactor)
- Stability studies of inhalation powders
- Inhalation powders formulation
- Surface analysis (API and excipient)
- Non-carrier based formulation
- Carrier-based formulation
- Excipient identification, sourcing and characterization
- Microbiology controls
- Expert inhaler development services
- Seamless integration between formulation and inhaler development
- Proven track record in developing market approved drug products for inhalation
In addition to inhalation formulation services and devices we also offer:
- Automated capsule filling, for supporting both clinical and commercial purposes
- Packaging and finishing, for supporting clinical purposes
6 Areas of Expertise in Off-Patent Products
- Antibiotics
- Corticosteroids
- Macrolides
- Mectins
- X-Ray
- Contrast Media Products