This week, SpeakPharma interviews Denise Sutton, Chief
Operating Officer and Site Head at Quotient Sciences’ Nottingham facility in the UK. Quotient Sciences is a drug development and manufacturing accelerator that offers the innovative Translational Pharmaceutics platform to support customers in overcoming drug development challenges. Sutton has been with the company for over 25 years.
In this interview, she provides insights into the evolution of Quotient Sciences’ Nottingham facility and discusses how the organization has transformed from a small 10-bed clinic to a comprehensive drug development campus with six GMP suites. She also shares her perspective on the company’s unique approach to integrating drug development services.
HIGHLIGHTS// evolution of Quotient Sciences’ Nottingham facility/ unique approach to integrating drug development services
How has the Nottingham site
transformed from when it was founded, to what it is today?
Initially, we were a small company with fewer than 50 employees, a 10-bed clinic, and a single lab. Over 90 percent of our work focused on gamma scintigraphic imaging (a diagnostic test that creates images of the body’s internal organs and tissues using gamma rays). Due to the short half-life radionuclides we used to label dosage forms, every product we manufactured had a limited time to be dosed.
At the end of 1999, we moved our headquarters to a purpose-built, two-storey facility—now known as Trent House on our now much larger Nottingham campus. We built three good manufacturing practice (GMP) suites on the top floor and three clinical wards on the bottom floor. These were very early days that marked the start of our Translational Pharmaceutics platform.
We continued to expand the range of scintigraphy applications we offered in response to changing customer requirements until, in 2008, when we approached the MHRA (UK’s Medicines and Healthcare products Regulatory Agency) with a new request. We asked if it might be possible to work at the same pace as we did in our scintigraphic imaging studies, but do so for conventional drug development, without the radiolabel.
We explored the application of ICH Q8 Quality by Design (QbD)
guidelines to introduce a compositional design space into the CMC section of
our regulatory dossier. This officially created a methodology for applying the
Translational Pharmaceutics platform, and we haven't looked back since.
Today, we have expanded substantially. Our Nottingham site is a
campus of five buildings. We have development and analytical labs, six GMP
suites, six clinical wards with a total of 85 beds (where we conduct healthy
volunteer phase 1 clinical studies), and many talented colleagues covering our
spectrum of CRO and CDMO services.
HIGHLIGHTS// officially created a methodology for applying the Translational Pharmaceutics platform/ development and analytical labs/ six GMP suites
How is Translational
Pharmaceutics applied to drug development programs?
We apply Translational Pharmaceutics across three core
applications: first-in-human clinical studies, drug product optimization
programs through rapid formulation development and clinical testing, and as a
part of human ADME (absorption, distribution, metabolism, and excretion)
programs.
No matter how a client chooses to work with us to apply
Translational Pharmaceutics, the benefits of using a single organization and
project management team to integrate services lets our clients remain in
control and one step ahead of the emerging data that impacts the success of
their molecule.
Over all these years, our flagship Translational Pharmaceutics
platform for drug development has remained unchanged in the way it empowers our
customers and offers them unparalleled flexibility.
HIGHLIGHTS// three core applications/ benefits of using a single organization/ clients remain in control
What would you say are the key strengths of Quotient Sciences’ Nottingham site? How do you support customer programs?
Nowhere else would a single project manager oversee such a broad
spectrum of activities, let alone be expected to ensure seamless, timely
progression across functions that in any other company (i.e. at other CDMOs or
CROs) would be delivered through multiple operating areas or through the use of
a combination of third-party vendors.
The project managers do face challenges. But by working with the project team, they are able to anticipate, avoid, and mitigate any impact whenever necessary. We know that time is incredibly valuable for our customers. A project Gantt chart is our project management team’s guiding light. I believe our project management team is truly world-leading – they communicate well, show great compassion, and lead with integrity.
I’m super proud of our high-performing, supportive, cross-functional teams that support our customers when they trust their molecules to us, and work collaboratively to deliver the best possible service. After 25 years at Quotient, I continue to really enjoy going to work. I am indebted to various colleagues for helping me continue to feel this way.
HIGHLIGHTS// project management team is truly world-leading/ high-performing,
supportive, cross-functional teams/ 25 years at Quotient
The contract development and
manufacturing organization (CDMO) space continued to grow at an impressive pace
in the second half (H2) of 2024, with significant progress being made across
cell and gene therapies (CGTs), antibody-drug conjugates (ADCs), novel drug
modalities, and digital solutions.Some of the key players in
the CDMO space include Lonza, EUROAPI, Evonik, SEQENS, Fujifilm Diosynth Biotechnologies, Quotient Sciences, Axplora, PolPharma, and Famar from Europe; Mission CDMO, LGM Pharma, Veranova, and Thermo Fisher from the US; and Samsung Biologics, Bora Pharmaceuticals, and Porton Pharma Solutions from Asia. Texas-based Mission CDMO
has been in the pharma industry for over 75 years.
Today, it is known for its comprehensive contract services and high-quality
manufacturing capabilities that have reinforced its position as a trusted
partner. View CDMO Activity Tracker for H2 2024 (Free Excel Available)Bora, PolPharma drive CDMO acquisitions; Samsung Biologics clocks over
US$ 4 bn in contract valueThe second half of 2024 saw
several high-value acquisitions and expansions that reshaped the CDMO
landscape. South Korea-based Samsung Biologics clocked a cumulative
contract value of over US$ 4 billion. It signed its largest manufacturing deal with an Asia-based pharmaceutical company, valued at US$ 1.24 billion.
It also announced a series of manufacturing deals with a European
drugmaker worth over US$ 668 million. Samsung Biologics is also building a dedicated ADC facility that is likely to be complete soon. Taiwan’s largest CDMO, Bora Pharmaceuticals, announced its second acquisition of the year. It
bought New Jersey-based Pyros Pharmaceuticals, a developer of rare disease treatments. Pyros recently launched Vigafyde, the only
ready-to-use vigabatrin oral solution and
the first new product approved to treat infantile spasms in 15 years. Bora also
announced a strategic investment in Tanvex Biopharma, thereby creating a
global platform for biologics development and supply.PolPharma acquired Ziołolek, a renowned manufacturer of dermatological products, medical devices, and OTC medicines, thereby
expanding its product portfolio. It also launched a state-of-the-art HPAPI (highly potent active pharmaceutical ingredients) facility in Poland, which is being seen as another step towards securing Europe’s drug supply chain.In other developments, Avid Bioservices got acquired
by funds managed by Ampersand and British healthcare
investment firm GHO Capital Partners in an all-cash deal worth US$ 1.1 billion. And Agilent Technologies agreed to acquire
Canadian specialty CDMO Biovectra for US$ 925 million, thereby enhancing its capabilities in gene-editing technologies and sterile fill-finish services. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Evonik, EUROAPI, Porton Pharma, GSK announce tieups, technological
expansionsSeveral CDMOs announced new
collaborations and acquired new capabilities to enhance their service
offerings. Evonik expanded its formulation capabilities for lipid nanoparticles used for mRNA and gene therapies through a collaboration with KNAUER Wissenschaftliche Geräte. This partnership aims to expand Evonik’s portfolio of biosolutions.Evonik is also restructuring its keto and pharma
amino acid business to focus on strategic core growth areas. Evonik launched Eudracap colon functional capsules for targeted delivery of oral drugs. These ready-to-fill
capsules are designed to release their contents specifically in the colon,
improving the efficacy of treatments for various gastrointestinal conditions.
Evonik also opened a new facility for drying aqueous dispersions of Eudragit polymers in Darmstadt, Germany. This facility will enhance Evonik’s capabilities in producing high-quality polymers for pharmaceutical applications.EUROAPI launched a new AI-powered Electronic Batch Record solution in collaboration with Aizon to enhance manufacturing productivity. This collaboration aims to digitize operations towards more data-driven manufacturing, focusing on small-scale productions and highly flexible plants.Porton Pharma Solutions has expanded its reach through several strategic
initiatives. In October, Porton entered into a partnership with
Shanghai InnoStar to enhance its service offerings beyond small molecules,
targeting peptides, oligonucleotide drugs, conjugated drugs, and advanced
therapies. It continued to grow its
capabilities by enhancing its GMP manufacturing capacity in Fengxian, Shanghai (China). The facility’s expansion is aimed at increasing the production of novel therapies, including peptides and oligonucleotide drugs. These moves are part of Porton’s broader strategy to position itself at the forefront of advanced pharmaceutical manufacturing.Corden Pharma is investing € 900 million (US$ 985 million)
over the next three years to expand its peptide platform facilities in Colorado
(US) and Europe. While the US site will help meet the rising demand for GLP-1
peptides, in Europe, CordenPharma will construct a greenfield facility for small
to large-scale peptide development and manufacturing.CDMO Touchlight signed a
licensing agreement with GSK that grants the drug behemoth non-exclusive rights to use Touchlight’s proprietary enzymatic doggybone DNA (dbDNA) technology for the development and production of mRNA-based products, particularly vaccines. Curia also integrated
enzymatic dbDNA solutions through a collaboration with Touchlight, enhancing mRNA
production for vaccine and cancer therapies. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Lonza, Merck, Dr. Reddy’s owned Aurigene invest in cell and gene therapiesThe CGT space continued to
draw both deals and investments. Lonza and Vertex signed a long-term
commercial supply agreement for Casgevy, the world’s first CRISPR/Cas9 gene-edited cell therapy, to treat sickle cell disease and beta thalassemia. This agreement includes manufacturing at Lonza’s Geleen (the Netherlands) cell therapy manufacturing facility, with plans to expand to Portsmouth, New Hampshire (US).Miltenyi Biotec began manufacturing lentiviral vectors for Adaptimmune’s Tecelra, the first engineered TCR T-cell therapy for the rare soft tissue cancer synovial sarcoma approved by the US Food and Drug Administration.Merck KGaA commenced commercial production at its first GMP-compliant manufacturing line for cell culture media
(CCM) in China. This facility addresses the growing local demand for quality
custom CCM used in biopharmaceuticals, vaccines, and novel therapeutics.Aurigene and Edity Therapeutics announced a strategic collaboration in cell therapy, with Aurigene providing cell therapy discovery services to support Edity’s clinical development. Additionally, Aurigene and its parent, Dr. Reddy’s Laboratories, signed a memorandum of understanding (MoU) with Kainomyx for the development and commercialization of an affordable anti-malarial drug. ProBio and UCI Therapeutics signed an MoU for a comprehensive collaboration in gene delivery technologies, including viral and non-viral approaches. Additionally, Korea’s VaxCell-Bio partnered with ProBio to accelerate
the development of its chimeric antigen receptor (CAR)-related therapies.The ADC market continued to
be a hotbed of innovation and strategic expansion. Merck KGaA invested € 70 million (US$ 75 million) to triple its ADC manufacturing capacity at its Missouri (US) facility, aiming to support the rising demand for oncology therapies.Sterling Pharma entered into a partnership with GlycoNex to
support the clinical trials of their ADCs that target solid tumors. And, NJ Bio and Charles River Laboratories also announced a collaboration to optimize ADC manufacturing.The adeno-associated viral (AAV) vector field also saw activity with Rentschler Biopharma and Forge Biologics
announcing the launch of a new service offering and a manufacturing platform, respectively. Similarly, Andelyn Biosciences was selected by Hubble Therapeutics to
manufacture clinical grade AAV.Meanwhile, Lonza has gone in for a restructuring exercise in order to become a “pure-play CDMO”. It has exited its capsules
and health ingredients business, and adopted a new organizational structure.
The Swiss CDMO has also extended a
collaboration with a major global biopharmaceutical partner for commercial-scale manufacture of ADCs. View CDMO Activity Tracker for H2 2024 (Free Excel Available) Our viewAs pharmaceutical development becomes increasingly complex, CDMOs are no longer just manufacturing partners, but critical innovation hubs. Little wonder then that 2024’s biggest pharma deal was in the CDMO space – Novo Holdings’ US$ 16.5 billion buyout of Catalent. This trend should gather momentum. We expect more M&A activity in this space in 2025.
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