Science & Technology

Nova Licensed Products

With in-house clinical expertise we have in-depth knowledge of current deficiencies in the treatment of rarer diseases, with a particular focus on creating liquid versions of existing medicines for precision dosing and use in paediatrics. Our formulation team have successfully created stable, liquid versions of several existing medicines, now brought to market, and continue to work on our pipeline.

Manufactured using our own equipment and facilities, we control all aspects from development batches to the scale-up of commercial batch size, QC testing, labelling and packaging, and QP release. Stored onsite in temperature-controlled facilities, we supply directly to NHS hospitals and GB community pharmacies, and via our distribution partners for territories outside of GB. For territories in the EU, we have our sister company, Nova Laboratories Ireland, for EU import testing and QP release before distribution within the EU community.

For more information on our licensed products, head to our Knowledge Centre

Sterile Manufacturing

Thanks to our technical excellence, operational know-how, and specialised experience we have a global reputation for complex aseptic processing of pharmaceutical, biopharmaceutical and medical device products when terminal sterilisation is not an option. Capable of routine liquid fill/finish from small hand filled batches to semi-automated batches of up to 10,000 vials, we are your trusted partner for any clinical trial work from pre-clinical testing through to large Phase III trials. We also provide a “turnkey” solution with in-house analytical and microbiological testing, clinical trial labelling and packaging, and QP release.

Having used gassed isolators since the founding of the Company, we are experts in their design, construction, and use. With our unique in-house engineering services, we have successfully incorporated many complex processes into them, including the world’s first cGMP spray drying process approved by both the EMA and FDA. We are happy to discuss the feasibility of any novel process that requires aseptic manufacture.

Our extensive experience in filling a wide range of products, either formulated in-house or preformulated, includes:

• • Small molecules
• • Peptides
• • Proteins
• • Monoclonal and polyclonal antibodies
• • Immunoconjugates
• • DNA plasmids
• • Live biologicals (category 1 and 2 bacteria, viruses and phages)*

*Dedicated Facility

With the following examples of novel presentations:

• • Liposomes
• • Oil-in-water and water-in-oil emulsions
• • Nanoparticulate dispersions
• • Variable-rheology implants
• • Protein-coated implants
• • Needle-free injectors (powder and liquid)
• • Next generation ambulatory infusers
• • Powder filling (vial, sachet)

We endeavour to form long-lasting relationships with our clients, which includes undertaking contract manufacturing of commercial products, either as a natural progression when an existing client’s product comes to market, or for new clients with products already on the market.

'Specials' Manufacturing

We are one of the UK’s leading independent suppliers of ‘Specials’ and non-sterile clinical trial medicines for healthcare providers and the veterinary sector. With 30 years’ experience, our business is based on our strong ethical beliefs of quality, service and value and we continue to work closely with the NHS.

Our unique facilities allow us to reformulate individual patient dosing requirements. We have a wide variety of formulations available to our customers, and we are continually expanding our range to satisfy patient needs.

• • Solutions
• • Suspensions
• • Mixtures
• • Creams
• • Ointments
• • Lotions
• • Capsules
• • Suppositories
• • Enemas
• • Nasal Drops
• • Cytotoxic Products
• • Controlled Drugs

Stabilisation Technologies

We are able to offer two proprietary stabilisation technologies, HydRIS® and VitRIS®, to enable customers’ thermolabile products to remain stable throughout storage and distribution, even in hot climates.

The Hypodermic Rehydration Injection System (HydRIS®) dries a formulated solution or suspension of an unstable API around the filaments of a small section of filter membrane, to create ultra-thin sheaths and webs of dried, stabilised product. The coated membrane is enclosed within a custom-designed housing, resulting in a dramatic increase in thermal stability. The unique advantage of this technology is that the dried API can be reconstituted and injected into the patient as a single action (i.e. no pause is required for dissolution). This technology is particularly useful for low volume injectables such as vaccines, including live viral and bacterial products.

The Vitrified Readily Injectable Suspension (VitRIS®) uses aseptic spray drying to produce thermo-stable spherical particles of a formulated solution or suspension of an unstable API. By varying the formulation and drying parameters, it is possible to vary the density of the resultant particles, to match the density of a non-aqueous injectable vehicle, thereby resulting in a stable suspension. Upon injection, the particles dissolve to release the API into the body.