Upperton Pharma Solutions now has a fully commissioned
60 square metre non-GMP pilot plant, mirroring our GMP manufacturing facility.
The pilot plant is equipped for three scales of spray drying:
•ProCept 4M8-Trix for batch sizes of up to 300g
•Upperton
Intermediate Spray Dryer for batch sizes of up to 1kg
•GEA
Niro Mobile Minor for batch sizes of up to 3kg
In addition, the pilot plant has all of the powder
handling and processing capabilities offered in our GMP manufacturing facility,
for downstream processing of spray dried powders into final dosage forms.
Formulations and processes optimised in our R&D
laboratories can be quickly scaled up to produce non-GMP material for
toxicology and stability studies and CMC batches. The mirroring of our GMP
capability enables a rapid seamless transfer of processes into clinical
manufacture, along with all of the expertise and formulation-specific know-how
built up during the development stages.
In 2014, Upperton Pharma Solutions was awarded a
prestigious Horizon 2020 grant as part of a European consortium led by Mymetics, a pioneering company at the forefront of the development
of virosome-based vaccines.
The MACIVIVA goal was to develop dry powder, thermostable, cold-chain
independent virosomal vaccine formulations for non-invasive needle-free
administration. Such solid form vaccines should reduce the cost and improve safety
and compliance in National Immunisation Programs, particularly in the developing
world.
The Upperton formulation development team successfully developed spray dried
formulations of HIV virosomal vaccines for both oral and nasal delivery routes.
The optimised processes were scaled up and transferred into the company’s GMP
clean room facility, where batches of both the Oral and the Nasal formulation
were manufactured.
Retained virosome structure and
particle size on spray drying
Preserved antigenicity in the
final solid vaccine forms
Retained the initial vaccine
immunogenicity after storage for three months at 40°C / 75%RH
Both nasal and oral formulations
were successfully dosed in animal models
The immunogenicity of the nasal
solid vaccine form was comparable to subcutaneous injection of the
reference liquid vaccine
Participation in the MACIVIVA
project has enabled Upperton to expand their technical capabilities to include
GMP manufacture of solid form virosomal vaccines.
Successful Completion of N2 Business Growth Grant
In October 2017, Upperton was delighted to be awarded grant
funding by the Nottinghamshire-based N2 Business Growth Fund to support
investment into a capital project leading to business growth and the creation
of new sustainable jobs. Upperton used the funds to support the establishment
of a GMP clinical manufacturing capability at its Nottingham site.
The success of the project was easily measured:
In November 2018 Upperton Pharma Solutions’ manufacturing facilities passed
inspection by the UK Medicines and Healthcare products Regulatory Agency. The
MHRA licence allows the company to develop pharmaceutical formulations for
oral, nasal and pulmonary delivery right through from early feasibility studies
to scale up and Phase I & II clinical manufacture, all from its Nottingham
Science and Technology Park site.
Upperton Pharma Solutions’ new pharmaceutical spray drying manufacturing facilities at Nottingham Science and Technology Park have successfully passed inspection by the UK
Medicines and Healthcare products Regulatory Agency (MHRA).
A pharmaceutical spray drying contract development and manufacturing organisation (CDMO),
Upperton Pharma Solutions moved to its new facilities on Nottingham Science and Technology Park from its previous headquarters at BioCity Nottingham in March 2018, as part of a planned expansion of its services.
The company has invested heavily in the new facilities both in terms of building enhancements and in the expansion of its processing and analytical
capabilities.
The successful MHRA inspection provides Upperton Pharma Solutions with the
necessary MHRA licenses for manufacture, downstream processing into capsules
and tablets, as well as release of spray dried formulations of Biotherapeutics and small molecule APIs for clinical trials.
The company is now able to develop pharmaceutical formulations for oral, nasal and pulmonary delivery from early feasibility studies to Phase I & II clinical manufacture, from its Nottingham Science and Technology Park site.
Richard Johnson, CEO and Founder of Upperton Pharma Solutions, said: “We are absolutely delighted with the expansion of our capabilities in GMP clinical manufacturingand look forward to seeing our clients’ projects progress within Upperton, from early formulation development studies right through to clinical manufacture.”
“The positive endorsement by the MHRA will enable a seamless transition from R&D to GMP manufacture within the organisation, ensuring that all of the
project-specific knowledge and expertise developed in R&D will flow through to the GMP manufacturing processes.”
Paul Kelsall, Director of Clinical Trials Manufacturing commented: “This is a great opportunity for our business and is a result of our team’s commitment to
achieve the targets and aspirations of our business. We are looking forward to working with our clients and offering services from early stage development
through to clinical manufacture. These are exciting times for Upperton as we
continue to move forward and expand our capabilities.”
About
Upperton Pharma Solutions: At a time when the global CDMO market place is consolidating, Upperton Pharma Solutions remains as one of the few independent CDMO service providers with a specific focus on developing pharmaceutical
dosage forms using its specialised spray drying capabilities. Upperton provides a range of integrated services to the pharmaceutical and biotech sectors around the world. The services include: early feasibility studies, formulation
development for both small molecule APIs and Biotherapeutics for a range of
final dosage forms and GMP manufacture of materials for Phase I & II
clinical trials. Full analytical support, including ICH stability studies,
is offered.
The company is a privately-owned
organisation that has grown organically over almost 20 years and now employs 24 highly skilled personnel. Upperton Pharma Solutions has its headquarters in
Nottingham, UK.
Contact:
Klara Fisken
Business Development Associate
Upperton Pharma Solutions, Albert Einstein Centre, Nottingham Science & Technology Park
Nottingham NG7 2TN
T: +44 (0) 115 855 7050 (Monday to Friday 8.30am – 4.30pm)
Upperton Pharma Solutions will be exhibiting at AAPS
PharmSci360 for the first time, with this year’s event running from November
5th – 7th in Washington, D.C.
·CEO & Founder Dr Richard Johnson and
Business Development Executive Annette Kleiser
will
be available at booth 1643 to discuss how Upperton can support your development
programme from early feasibility to clinical trials manufacturing
·Richard will also be presenting a scientific
poster titled “Developing Cold Chain Independent Vaccines - Spray-drying of
Virosomes to Produce Dry Powder Formulations”, on Tuesday
6th November
·This presentation will be based on the work of
the MACIVIVA project which has the end goal of producing pioneering virosome-based vaccines against life threatening dise
ases
Find Richard at Booth 1643 or arrange a meeting by contacting us.
Through
extending our capabilities Upperton’s family have grown from three members
of staff four
years
ago, to twenty-one staff this year. The latest staff updates are:
·Paul
Kelsall, Director of Clinical Trials Manufacturing
Bringing
experience in both sterile and non-sterile manufacturing, formulation
development and facilities management. Paul formerly worked for Boots, Reckitt Benkiser, Nova Laboratories and Aesica.
·Sarah
Bayliss, Director of Quality & Compliance
Experience of
implementing, maintaining and remediating quality management systems. Sarah
joins us from Aesica.
·Thomas
Williams, Head of Clinical Manufacturing
Experience in
developing and manufacturing investigational medicinal products for Phase I
and
II clinical trials. Thomas joins us from Quotient Sciences.
·Rebecca
Gray, Senior QC Analyst
Experience in
QC testing, early formulation development analysis and analytical method
qualification. Rebecca joins us from Quotient Sciences.
·Klara
Fisken, Business Development Associate
Klara joins us
from the University of Nottingham, where she has just completed an MSc in
Biopharmaceutical Biotechnology and Entrepreneurship.
·Ella
Rose, Junior Project Scientist
Ella joins us
from Nottingham Trent University as a year long placement student, where she is
currently studying towards a BSc in Chemistry.
Our newly expanded Pilot
Plant has enabled us to provide our customers with a seamless transfer of
processes from laboratory to clinical trials manufacture. In particular we
offer three scales of spray dryer, all of which can also be operated in our GMP
plant. Spray dryers in our pilot plant include:
·ProCepT
4M8-TriX spray dryer
·Intermediate spray dryer
(Upperton design)
·Niro Mobile Minor
These spray driers
can spray dry a range of batch sizes (from 10mg to 3kg), allowing Upperton to
conduct feasibility studies at scale to enable rapid transfer and reduce risk
on scale up.
Successful First
Batches from Upperton Clinical Manufacturing Plant
Upperton has successfully produced its first batches of
product from its clinical manufacturing plant during August.
The inaugural batches were:
·Spray dried from solutions containing a range of
excipients.
·Spray dried powder was both filled into capsules
and tableted.
·Analytical tests including particle sizing,
hardness and dissolution testing were performed.
The Upperton GMP manufacturing team were delighted to
successfully complete these initial batches and now look forward to further
work for an expanding customer base. To initiate discussions and learn more
contact Upperton.
Upperton adds Mass Spectroscopy to its analytical capabilities
Upperton Pharma Solutions has now completed the installation and commissioning of its Agilent 1100 series LC/MSD (Liquid Chromatography mass selective detector) with ESI (Electrospray ionisation). The new capability will allow Upperton to offer clients molecular mass analysis, useful for assessing purity and detecting API decomposition or modification during formulation processing.
Contact Upperton and discuss how we can use this technique to characterise your API before, during and after formulation and dosage form development
Upperton will be attending the 9th International GI-Targeting Seminar hosted by Evonik in Darmstadt, Germany
This 2-days seminar takes place between June 6-7, 2018 and offers attendees hands-on practical sessions in the Evonik laboratories.
Upperton Pharma Solutions we will be attending the APS Regulatory Essentials Conference in Loughborough 22nd-23rd May. If you are there, talk to us about your GMP Spray drying requirements
With over 20 years of experience we have successfully spray dried, formulated and characterised a vast range of pharmaceutical and biotechnology products for companies across the globe.
