Human Drug Formulation & Analytical Development
EirGen was founded on experience and knowledge in high potency molecules. The addition of an aseptic steriles line using isolator technology fits well with EirGen’s existing experience in containment.
Our R&D team are resourced and experienced to deliver high value medicines in both the OSD and SFF (aseptic) spaces.
Capabilities in formulation and analytical development are strongly focused on applying this experience on multiple platforms to development of innovative medicines as well as standard generics in the high containment space.
EirGen will always try to add value to the product. For example, in paediatric medicines, we use easy-to-swallow liquid formulations that can be sprinkled on food while for geriatric medicines, our pellet technology delivers medication that can be suspended in water.
We have also reformulated products from soft gel to banded liquid filled hard capsules, converting solid formulations to liquid filled hard capsules, manufacturing combination products using our IMA encapsulation machine capable of filling combinations of pellets, powders, mini-tablets, or liquids into hard capsules or converting a vial product into a pre-filled syringe version for easier administration.
EirGen offers these R&D services either in partnership with an interested third party or as a contract development activity.
Veterinary Drug Formulation & Development
EirGen has a portfolio of five companion animal veterinary products in both the oncology and renal space.
These drugs are tailored to the dose presentation required for the target species and clinical and toxicological research has been completed or is in various stages of progression for each of these molecules.
EirGen is identifying new candidate molecules to add to this portfolio and is strongly focused on combining clinical research into new indications for existing off-label use of human drugs as well as bringing some of our parent company OPKO Health’s novel drugs into the companion animal space.
EirGen is always open to new collaborations in the veterinary space and sees this key strategic area as strongly complementing our well-established activity in human health.
Manufacture of High Potency Finished Product
EirGen has two high containment manufacturing suites along with a new state-of-the-art high containment packaging facility.
Our manufacturing suites support the manufacture of high potency finished product in multiple formats including film-coated tablets, soft-gel capsules and hard-shell capsules (powder/liquid-filled).
The design of our suites is such that all areas use single pass, cascading negative air pressure systems back to dedicated handling areas to enhance in-room containment.
Additional technology includes performance-qualified, closed-loop isolators; down-flow and powder containment booths and local exhaust ventilation (as required).
Risk-dependent PPE (air suits, masks and so on) is used as a secondary control throughout processes.
Integrated Pharmaceutical Packaging & Global Serialisation
We’ve recently qualified our new state-of-the-art high containment packaging facility which means we now offer the complete solution from manufacture right through to serialisation for global markets.
Packaging formats supported include blister, bottle, sachet and cartoning. Serialisation is supported for all finished packaging formats.
Quality Batch Release to Global Markets
Quality Excellence / Systems
• In EirGen, Quality is a state-of-mind with WORLD CLASS STANDARDS OF QUALITY to safeguard patients in place across all operations;
• We provide simple, robust, sustainable and compliant quality processes that add value with zero-defect thinking;
• Our Pharmaceutical Quality System (PQS) is designed to support different processes by assuring compliance with regulatory requirements in both clinical and commercial supply.
Regulatory Affairs & Clinical Research for Global Markets
Built on many years of experience, EirGen has a very stable regulatory and clinical team who manage our own product portfolio in collaboration with global marketing partners as well as supporting the registration of OPKO’s products with their partners for registration of their new drug developments in territories outside of the USA.
The clinical team execute studies required to support new developments and the building of dossiers on behalf of our partners.
Clinical experience ranges from PK studies – exploratory for new drug developments and bioequivalence studies for generic drug development, toxicology studies in support of veterinary drug applications as well as clinical efficacy studies for veterinary drugs.
Apart from management of numerous US ANDAs, NDAs (via OPKO), MAAs in the EU and global registrations for human drugs, EirGen has also successfully navigated a veterinary MUMS NADA in the US.
Depending on the partnership model undertaken, EirGen can offer the strategic regulatory and clinical support required by the customer.