Arcinova is a Contract Research and Development Organisation (CRDO), providing the pharmaceutical industry with a comprehensive range of services.
At Arcinova, we are focused on Process Research, Development, Scale-Up and small scale manufacturing, including bioanalysis, DMPK, regulatory and consulting services, covering drug candidates in Development and launched to the Market. We are trusted partners for our customers, supporting their development and delivery programmes for new medicines in a timely and cost effective manner to sustainably improve the health and wellbeing of society.
Our mission at Arcinova is to deliver best in class technology services in the fields of contract research, development and small scale manufacturing to maximise effectiveness whilst minimising risk and overall cost.
Arcinova staff have extensive experience in the Chemistry, Manufacturing and Controls (CMC) aspects of molecule development which, in the pharmaceutical arena, spans the discovery interface to First in Human clinical studies and beyond.
Our services can be provided either on a stand alone basis or as part of an integrated service offering depending on your particular CMC needs.
Arcinova continues to invest in facilities and people to ensure that all aspects of synthesis scale up and support are comprehensively resourced.
We seek to develop robust, economic and scalable API manufacturing processes which can be fine-tuned to your needs in terms of physical form (morphology, salt selection and particle size) and have extensive analytical capabilities to support this. We are closely integrated with our Drug Product development team as part of a more comprehensive Drug Substance / Drug Product development service.
We also work closely with alliance partners where, subject to customer requirements, we can offer a further scale up capability from > 10kg up to 100’s of Metric Tonnes
Current development projects include additional investment in GMP process chemistry facilities (up to 5Litre - complete), walk-in fume cupboards (up to 20litre - complete) and kilo lab capability (30-50litre - pending).
ARCINOVA provides comprehensive bioanalytical services that complement your drug discovery and development needs from preclinical development through to market. Within our state of the art facility, our experienced team can develop, validate and implement bioanalytical LC-MS assays for small and large molecule drugs, generics and biomarkers. Arcinova can also synthesise stable labelled standards to help provide increased speed, sensitivity, selectivity and robustness of LC-MS assays avoiding matrix effects and producing more reliable data.
In addition, we have extensive knowledge and experience of Inductively Coupled Plasma Mass Spectrometry (ICP-MS), particularly for platinum-containing drugs, but also spanning a wide range of elements and matrices. Our new services now include elemental ADME and LC-ICP-MS elemental speciation. Whether you need to make a quick internal decision with data generated using the principles of scientific validation, or require more rigorous EMA/FDA compliant bioanalysis to support eco-toxicology or pivotal bioequivalence studies, we can help.
We can determine the metabolic fate of your molecule or study its activity in cell based systems. Working in collaborative teams, our knowledge base draws from biotransformation specialists alongside biochemists and synthetic/analytical chemists. Our analytical capabilities include high resolution mass spectrometry, NMR and 96 well plate spectrophotometric technology. Both radiolabelled and non-radiolabelled samples are equally accommodated.
In our state of the art facility, incorporating the latest IT solutions, our experienced team have access to cutting-edge software, such as Watson™ LIMS, LabNotes™ ELN, Nugenesis™ SDMS and Laura™ CDS. When combined, these systems provide enhanced speed, efficiency and data security to support your data transfer and regulatory needs.
Early Stage Formulation Screening & Development for both aqueous and lipid based formulations.
ARCINOVA have established expertise and technologies that are routinely applied to the understanding of active pharmaceutical ingredients (APIs), how best to formulate them for clinical and non-clinical applications, what their stability characteristics are and how to manufacture the formulations of choice reproducibly. A range of product types are developed, including those containing highly potent, cytotoxic or radiolabelled APIs, the most common being:
Solutions (aqueous and non-aqueous), suspensions and intravenous formulations for clinical or non-clinical use
API in a capsule or API in a vial with an appropriate aqueous or non-aqueous constitution solvent for early phase clinical trials (including AME studies).
Formulation development programs can be conducted in isolation but are most powerful when combined with some or all of the synthetic, analytical, microbiological, clinical product manufacturing and regulatory CMC expertise available within ARCINOVA.
Our range of services related to drug product include:
With over 20 years as part of one of the top 5 global pharmaceutical companies, combined with 5 years working for one of the world’s largest CROs, the Arcinova team have a unique insight into your needs.
Our experts can work individually, collectively or as part of your development project team to assess the data from your compound and recommend a path forward to achieve rapid drug registration, solve ongoing problems or carry out due-diligence.
Whether you require expertise or advice in a particular area or a more integrated, holistic approach, we are here to help.
The dossier team at Arcinova have the knowledge and experience to advise on the CMC content of clinical trial applications and/or to prepare the CMC aspects of these applications directly from the relevant source data. This service can be accessed on a stand-alone basis or as part of an integrated Arcinova CMC service. This service is also provided for clinical trials designed to study the absorption, metabolism and excretion of pharmaceuticals which have been radiolabelled
Solid State: Solid-state NMR (ssNMR) data are essential for those seeking to fully understand the materials science aspects of Active Pharmaceutical Ingredients (APIs) and their products. This technology and the associated interpretive expertise is available within Arcinova and can be accessed either in isolation or as part of an integrated approach to pharmaceutical engineering and problem solving.
Solution-State: Understanding molecular structure and dynamics is fundamental to many aspects of drug discovery and development. Arcinova’s NMR facilities and associated interpretive expertise provide a means of rapid structure elucidation to deliver crucial information across a diverse range of applications, including those requiring the analysis of 14C material.
Our qualified and experienced microbiologists pride themselves on applying their knowledge and skills to ensuring that pharmaceutical products are safe and meet today’s rigorous quality specifications and regulatory standards.
Facilities and Equipment
Our purpose built microbiology suite comprises a media preparation area (including a media autoclave, two microbiology assay rooms with microbiological safety cabinets and a laminar air flow cabinet), a Grade C cleanroom with a Grade A positive pressure isolator and a waste disposal area complete with discard autoclave. The suite is equipped with a range of equipment such as continually monitored incubators, sterility testing apparatus, water baths, cold storage and microscopes.
A full method development/validation service is offered to support application of the following key microbiological techniques and as method development, validation and testing can all be performed at one Arcinova facility, there is no need for time consuming technology transfer activities. In addition, we are equipped to perform microbiological testing on radiolabelled, highly potent, cytotoxic and controlled substances.
Microbiological Aspects of Formulation Development:
Clinical manufacturing support:
Quality control release testing:
Other microbiological services:
Arcinova offers a comprehensive and high quality microbiological service encompassing a range of techniques and at all stages from their development through to their application. These services can be accessed on a transactional basis or as part of an integrated service offering such as pharmaceutical formulation development, manufacturing and quality control testing activities.
The FDA guidance for Safety Testing of Drug Metabolites recommends that the structure of any metabolite which may represent more than 10 % of the exposure in humans should be formally elucidated. The earlier a disproportionate metabolite is recognized and characterised in the drug development process, the lower the risk of downstream delays with better planning of clinical studies.
The expertise and experience, in conjunction with state-of-the-art technology, are available within Arcinova to advise on the optimal approaches for completion of metabolite isolation and identification. Where possible, isolation can be circumvented by hyphenated technologies. The in-house mass spectrometry – Nuclear Magnetic Resonance platform not only enables identification of metabolites, but it permits quantification within a biological matrix.
High quality stability testing of APIs or Drug Products is a critical part of the drug development process, ensuring that suitable and justifiable, re-test dates or shelf-lives are applied during all clinical phases.
Arcinova teams have many years experience in the provision and interpretation of high quality analytical, microbiological and materials science based stability data. These studies are supported by use of our state of the art, 'walk-in', ICH compliant stability chambers, a number of smaller, reach-in, units for investigative studies and ICH compliant photo-stability testing equipment. Stability testing services can be provided for discrete client projects or as part of an integrated CMC service provision.
The teams at Arcinova are experienced in the development, validation, application and technology transfer of GC (headspace or direct injection), ion chromatography, LC and UPLC based methodologies.
These activities are supported by a range of LC detector types including UV, DAD, N2 emission, radiochemical, MS (single quadrupole, triple quadrupole and accurate mass), ICP-MS, conductivity, fluorescence and CAD. In the case of GC, FID or TCD detection are available. Chromatographic services can be accessed for discrete projects or as part of integrated Arcinova services.
For LC-MS/MS and UPLC-MS/MS assays, we have eight triple quadrupole instruments (Thermo, Sciex and Waters), six of which are equipped with Turboflow® technology for high-speed bioanalysis. Two systems are also equipped with FAIMS (high field ion mobility spectrometry) for enhanced selectivity applications. Our GC-MS system includes a Gerstel multi-purpose sampler for sensitive liquid and headspace analysis of small volatile molecules.
Chromatographic services can be accessed for discrete projects or as part of integrated Arcinova services.
14C Radiolabelling Services:
• Custom synthesis of 14C-labelled compounds to support pre-clinical ADME studies
• GMP synthesis of 14C-labelled compounds for human AME studies
• Expertise and facilities for handling 14C-labelled gases and volatiles including 14CO2, 14CO, 14CH3I
Where possible we will recommend the synthesis of additional 14C-labelled late stage pre-clinical intermediates, which can be stored and used in subsequent GMP studies. This approach can avoid the need for a re-synthesis, saving both time and cost when providing labelled material for the hAME study.
Stable Isotopic labelling:
• Synthesis of stable-labelled compounds incorporating 2H, 13C, 15N or 18O
• Ability to perform H/D exchange on API or late stage intermediates
The use of stable labelled standards is recommended by EMA (Guideline on Bioanalytical method validation), AAPS/FDA (BMV Conference Report) and endorsed by the European Bioanalytical Forum and Global Bioanalytical Consortium. They provide increased speed, sensitivity, selectivity and robustness of LC-MS assays avoiding matrix effects, producing more reliable data.
Additional Experience and Services:
• Ability to safely handle high potency / high hazard compounds (cytotoxics)
• Synthesis of metabolites & reference materials aiding Bioanalytical and Metabolism studies
• Degradants and process impurities to support API development,
• GTI assessment of confirmed impurity / degradant structures found during the scientific evaluation of investigational drug substances and products, to comply with ICH M7 guidance.
• Route development and precursor synthesis for labelling with 3H and short lived isotopes 11C and 18F
• Experienced in classical and non classical synthetic techniques, microwaves, H/D-cubes, automated peptide synthesis, microbiological and bio-catalysis.
ADME and DMPK Studies Services
Product Quality Control and Assurance Services
Liquid Chromatography Coupled Mass Spectrometry Methods Services
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