Learn about us from the beginning and the founding principles of our success
Our story began in the 1980s, when founder Dr Peter White led a team of fellow NHS pharmacy colleagues who shared in his belief that pharmaceuticals could be made more effectively, efficiently and safely than conventional approaches of the time dictated.
The founder of Nova Laboratories Ltd first uses gassed isolator technology in the NHS.
Nova Laboratories Ltd is incorporated as a Private Limited Company on 25th November.
The Company receives a manufacturing licence for ‘Specials’ (MS 13581 & MANSA 13581) and on 1st April officially starts trading as an independent supplier of sterile and non-sterile ‘Specials’. The Company has 24 ex-NHS employees, two 2-glove isolators and operates from two sites located within the grounds of the Leicester Royal Infirmary and Leicester General Hospital.
The Company moves to its current site, now known as Building A, and invests in an additional 4-glove isolator. The Company receives a licence for GMP manufacturing (MIA 13581) which at this time included authorisation for manufacturing both Commercial and Clinical Trials medicines.
The Company continues to pioneer the use of gassed isolators and develops its own designs of hybrid rigid base and top, flexible walled isolators and gas generators, still in use today.
The Company completes validation of Building B, a dedicated facility for antibiotic bone cement manufacture, with the capacity to produce 2 x 200 kg batches a week.
The Medicines for Human Use (Clinical Trials) Regulations come into effect and the Company receives a manufacturing licence for Investigational Medicinal Products (MIA(IMP) 13581).
The Company completes the validation of Building C, a new aseptic filling facility dedicated to live biologics (viruses, bacteria and phages), and installs and validates the world’s first GMP Aseptic Spray Dryer, available for contract manufacture.
The Company conducts a training session for the MHRA on the use of gassed isolator technology.
The Company acquires the patented drug delivery and stabilisation technologies HydRIS® and VitRIS®.
The Company relocates commercial manufacture of antibiotic bone cement to a larger, dedicated facility, Building D, capable of producing 4 x 250 kg batches per week. Work begins on the conversion of Building B into a dedicated cytotoxic facility.
The Company completes its centralised GMP store, Building E, supporting all four manufacturing facilities.
The Company receives an Orphan Drug Marketing Authorisation in the EU and launches its first Nova-branded licensed product, with exclusive access to the market for ten years.
The Company receives FDA approval and a seven-year exclusive licence for its first Nova-branded licensed product in the USA.
The Company receives approval from the FDA and EMA for the contract manufacture of the world’s first aseptically spray dried pharmaceutical product.
The Company receives approval from the FDA and EMA for the contract manufacture of the world’s first CAR-T Therapy.
The Company receives approval from the FDA and EMA for the contract manufacture of the world’s first AAV-based Gene Therapy.
The Company launches its second Nova-branded licensed product in the EU. Throughout the pandemic, the Company supports the NHS with the supply of ‘Specials’ and becomes involved in the clinical manufacturing of several early stage COVID-19 therapeutics and vaccines.
Nova Laboratories Ireland Ltd becomes operational to continue the supply of products to the EU.
The Company launches its third Nova-branded licensed product in GB.
Our expertise has set us apart from competitors in providing solutions to different healthcare needs and patients with clinically complex conditions a better quality of life.
We take pride in our ability to develop, manufacture and distribute niche licensed medicines for unmet needs.
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As our founding specialty in 1994, we are constantly improving and developing the manufacture of bespoke special medicines and continue to be a trusted name in the industry.
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We have a strong reputation for developing novel aseptic processes for our clients, such as spray drying, as well as routine fill/finish for both Clinical Trials medicines and commercial products.
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Our passion for innovative medicine led to the acquisition of bespoke stabilisation technologies, HydRIS® and VitRIS®, to facilitate the stabilisation and storage of temperature-sensitive medicinal products.
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Our manufacturing support has always been recognised as vital to the successful production of pharmaceuticals, with a unique ability to engineer solutions.
Under shared oversight, our highly experienced quality, analytical, and validation teams provide the necessary support to produce quality products to cGMP. From equipment to facilities, our engineering team can design and build everything in-house, and provide in-service maintenance. Utilising the most up-to-date CAD/CAM underpins our ability to provide quality by design and sustains our reputation as a globally recognised aseptic manufacturer for novel processes. For clients using us for contract manufacture, this can simplify a complex technical transfer process into a “turnkey” solution.
Our facilities have always been designed by us, and built by us, to meet our exacting requirements.
Operating in our unique cleanrooms, manufacturing is split across several dedicated facilities, served by a shared GMP central store. Non-sterile compounding operates from their own dedicated Grade D cleanrooms for the manufacture of all ‘Specials’. Sterile manufacturing operates from several facilities depending on dedication, with separate facilities for small molecule and biologics, live biologics and antibiotics. Using our own isolators, we can provide routine liquid fill/finish, powder filling and spray drying aseptically. Analytical and microbiological testing facilities are also situated on the main site of manufacture, ensuring efficient integration into the workflow. Our in-house engineering facility houses the latest CNC machines providing the highest quality parts for GMP equipment.
See What We Do
We listen to the needs of our customers to strategically develop practical solutions to their clinical challenges.
We understand that ‘the whole is greater than the sum of its parts’ and always look to develop into other areas of healthcare.
Our expertise and services stem from our deep understanding of the pharmaceutical industry and intricate knowledge of pharmaceutical manufacture.
We see where things can improve and look to be the first in leading the continuous advancement of our industry.
We are constantly inspired by medical advances, seeking new ways to incorporate future technologies to enhance our processes.
Transparency and integrity have always been important to us, as a privately owned and family-run business.
We encourage open and honest communication, and embrace a collaborative relationship with our clients. Our commitment to developing products, meeting manufacturing standards, and ethically promoting and distributing our products ensures robust frameworks are in place to maintain the transparency of our professional relationships.
If you have any questions or would like more information on our products or services, please do not hesitate to get in touch.
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