Aptuit provides drug development services to pharmaceutical and
biotechnology companies worldwide. Our development services are
based upon state-of-the-art facilities and timely delivery of quality data.
A wealth of experience allows Aptuit to help you define the best
strategy for the development of your compound. All of this is driven by
your ultimate goal – getting to market faster.
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The active pharmaceutical ingredient (API) is a key element of the drug
development process – all further development is dependent on its
supply. Given the integral role of API and Aptuit’s commitment to
streamlining and supporting the drug development process, it is fitting
that Aptuit offers a wide range of API services on a global scale. These
services span the range of radiolabeled API for preclinical ADME work to
commercial production of API post-NDA approval. A notable feature is
the ability to manufacture highly potent APIs.
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Our dedicated immunoanalytical team at Aptuit has a collective
experience of over 40 years, providing comprehensive and
innovative approaches to immunoassay. Our scientists’ knowledge
and expertise is gained from academia and industry and applied
across a range of therapeutic areas. The immunoanalytical group
support assay development and validation with applications in
discovery, preclinical/clinical sample analysis and immunogenicity
testing.
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Biotherapeutics have the potential to elicit an unwanted immune
response and a strategy to characterise this response must be in place
for clinical trials. Indeed, consideration of immunogenicity is initially
developed in the pre-clinical phase in order to assess the potential
effect such a response may have on drug activity and PK. Aptuit
engage a three stage approach as recommended in the EMEA
guideline on immunogenicity assessment of biotechnology-derived
therapeutic proteins (EMEA/CHMP/BMWP/14327/2006).
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Potential immunotoxicity of therapeutic compounds is a major
consideration in drug development. Aptuit’s toxicology and
immunoanalytical groups have a wealth of experience in conducting
immunotoxicology studies in state of the art AAALAC accredited
facilities supplemented by analysis of a range of immunological
parameters appropriate to the drug’s mechanism of action.
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Aptuit’s acquisition of GlaxoSmithKline’s Medicines Research Centre in Verona,
Italy expands and bolsters Aptuit’s integrated scientific capability and expertise
for the benefit of our customers globally.
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Aptuit Verona Integrated Drug Discovery Service
Aptuit’s facility in Verona, Italy expands and bolsters Aptuit’s integrated
scientific expertise and operational capabilities for the benefit of our global
customers.
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Aptuit Verona Clinical Pharmacometrics
Our pharmacometrics team provides planning and analysis support for a wide
range of clinical studies as well as entire clinical plans from First-Time-In-
Human through to proof of concept clinical trials.
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Aptuit Verona Medicinal Chemistry & Computational Chemistry Service
Aptuit’s strategy is to work with our clients to develop innovative, robust, and
cost-effective chemistry solutions for any of their medicinal or computational
chemistry needs from hit identification (hitID) through to candidate selection.
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From FIM to PoC and Beyond
The challenge of the development in new drugs from candidate selection to
launch resides in the high clinical attrition rate. In fact, only 8% of new drugs
will successfully make it up to launch and the attrition rate for new molecules
entering clinical development is on average 85%. The probability of success
for compounds in Phase I & II has a significant impact on overall development
costs, in a way that clinical development accounts for approximately 60% of
the cost for each new drug.
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Pathology is the integrative discipline by definition, with a long tradition of
integrating structure and function of disease. Pathology possesses a unique
skill, microscopic interpretation that can be applied to the evaluation of the
expressed phenotypes in both humans and animals. Pathology uses multiple
and irreplaceable tools, particularly histology, ultra structure techniques and
biomarkers.
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Aptuit Verona Pharmacology and Safety Pharmacology Service
Pharmacology and Safety Pharmacology can support all phases of the Drug
Discovery process from Target Validation to Candidate Selection, FIM and
beyond, in a fully integrated manner with other preclinical disciplines. Our fully
integrated approach, working closely with colleagues in Medicinal Chemistry
and DMPK, allows us to produce high-quality candidates and reduce candidate
attrition rates. We have experience and expertise in a wide variety of target
types including: GPCR targets, ion-channels, transporters and enzymes.
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Aptuit Verona Analytical Sciences
Aptuit Verona offers unique integrated analytical capabilities and expertise. It
delivers complete and high quality packages of analytical services for drug
discovery and development of chemical entities customized for each phase,
from early definitions through a fully validated GMP environment to analytical
tech transfer. This translates in to benefits for our customers and is assured by
a seamless transfer of knowledge and methods from one phase to the other.
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Aptuit Verona Chromatography
Aptuit provides chiral and achiral method development as well as sample
analysis services. Chromatography experts offer a wide range of analytical and
preparative support for chiral and achiral compounds, using both HPLC and
SFC technologies.
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Aptuit Verona Clinical Sciences
Clinical Sciences includes activities such as discovery medicine, clinical trial
management, data management, pharmacokinetics and statistical services,
which span from the design and implementation of multi-faceted projects up
to proof of concept, through the design and implementation of single areas
within the client’s clinical development plan.
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Assessment of Potential to Prolong QT Interval
The ICH S7B guidelines highlight the importance of understanding the
consequences for development of a drug candidate with a potential to
prolong QT interval. Cardiovascular assessment in vivo along with in
vitro assessment at the HERG channel is recommended. If results from
these two tests are equivocal then further investigation in other models
are advised. Aptuit provide a fully comprehensive package of studies to
cover ICH S7B regulatory requirements, which can be monitored for GLP
compliance.
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Automated Robotic Powder Dispensing System
At our GMP manufacturing facilities in Kansas City, MO, our AutoDose’s
Powdernium™ can significantly improve your drug development
timelines and decision-making process by accelerating your drug to
First-in-Man studies. The system offers great flexibility by dispensing
drug substance directly into capsules, vials or bottles. It also minimizes
early formulation development, drastically decreases the amount of
drug substance needed to get to First-in-Man, and reduces analytical
development costs. Aptuit customers can access this technology within
the security of Aptuit’s GMP facility located in Kansas City, Missouri.
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Biochemistry Services for Protein and Peptide Drug Substances and Drug Products
Identification and Authentication
Peptide mapping procedures (e.g. peptide mass fingerprinting) are used
to identify the protein.
Comparability Testing
This service is used to assess whether process changes have had an
effect on the properties of a protein drug substance.
Separation
We offer a full complement of chromatographic as well as
electrophoretic separation techniques as listed below.
Related Substance Isolation and Characterization
Related substances may include such variants as oxidized forms,
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Aptuit Consulting - Drug Development Programmes
Development of new therapeutic entities can be a complex process
requiring the development of a sound strategy and a detailed project
plan. These are essential for progression of a compound through the
different phases of preclinical and clinical testing in a timely and
cost-effective manner.
Aptuit Consulting is an independent group
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Aptuit Consulting - Getting you to market faster
Development of new medical products for regulatory approval is
complex, costly, and time-consuming. There is a myriad of external
providers capable of undertaking work to achieve the discreet steps
within this process, but coordinating these steps within an appropriate
regulatory framework requires considerable skill and experience.
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Discovery support to full product development
Pharmaceutical development is one of the most challenging aspects of
pharmaceutical and biopharmaceutical innovation. It involves
navigating the complexities of pharmaceutical science and
manufacturing, while achieving regulatory compliance. Aptuit
recognizes that rising to today’s challenges requires a network of highly
skilled specialists and global, integrated pharmaceutical development
capabilities. With more than 500 scientists operating out of 330,000 sq.
ft. of state-of-the-art GMP/GLP laboratory and manufacturing capacity,
Aptuit is the global leader in pharmaceutical sciences.
Aptuit offers solutions tailored to our customers’ exacting needs
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Drug Product Mapping and Image Studies
Mapping and Image Studies
On a micron or sub-micron scale, solid samples such as powders, pressed
tablets or cast films typically exhibit non-homogeneous mixing of
components. This results in regions that are disproportionately more
concentrated in individual components, which can have major impact
on stability, delivery and other physical properties of the product. Our
powerful analytical techniques provide a wealth of chemical and
physical information on specific microscopic regions of solid samples.
Some of the most prominent techniques are:
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Drug Substance Amorphous and Disordered Materials
Preparation of Amorphous or Disordered Materials
We have experience with a broad range of methods of preparation of
amorphous and disordered materials including an amorphous screen
(see screening section). These methods are optimized based on the
drug substance of interest.
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Drug Substance Crystallization of Difficult Materials and Scaleup
Crystallization of Difficult Materials and Scale-up
Crystallization is the critical step in solid form control. We can help you
define a process that ensures the solid form you manufacture is the one
you want.
Crystallization Process Development and Scale-up
We have wide-ranging experience in all areas of crystallization. We can
take your compound through the stages of generating the first crystals,
polymorph screening, salt or cocrystal form selection and
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Drug Substance Solid Form Screening Polymorphs Salts Cocrystals
Traditional Polymorph Screen
Our standard screen is designed to identify most of the solid forms of
your drug substance.
Super Screen
A combination of traditional and proprietary technology, our
SuperScreen™ is a comprehensive polymorph screen. We have
developed and/or licensed novel proprietary technologies designed to
generate new solid forms of materials. The use of these technologies in
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Early Biotheraputic Development
Safety, efficacy and mechanistic analysis at Aptuit
The cellular and biochemical mechanisms involved in biotherapeutic
function are inherently complex. In depth characterization of the
mechanisms of action of biotherapeutics is required to successfully
support pre-clinical development to first in man. At Aptuit we have
expertise in the development of biotherapeutics and biosimilars. As
part of your early development program, Aptuit can provide specific
support to evaluate mechanisms of action, efficacy and PK / PD
assays in addition to our comprehensive range of standard safety
pharmacology and toxicology studies and in vivo efficacy models.
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With over 20 years’ experience of drug discovery and development,
Aptuit’s Efficacy Group has outstanding pharmacological expertise
covering a broad range of therapeutic areas. These services can be used
to screen test substances for lead candidate selection, and to test
pharmacological efficacy in a range of models. Protocols are individually
designed to meet the requirements of the Sponsor and studies are
conducted in a GLP environment (and may be monitored by QA if
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Rapid Ion Channel Electrophysiology (ICE) Screening Service
The advent of automated patch-clamp recording and subsequent
launch of Rapid ICE has revolutionized the use of electrophysiology in
drug discovery and development. Rapid ICE screening of compounds
for activity at the hERG ion channel has proved to be an invaluable
early safety assessment assay.
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Solid State Analytical Services
Techniques
• X-ray Diffraction
• Micromeretics
• Solid State Spectroscopy
• Sorption and Desorption
• Thermal Analysis
• Water Analysis
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Advancements being made in genomics, proteomics and systems biology are
transforming the drug discovery and development process, while facilitating
our understanding of the molecular underpinnings of disease. Translational, or
“bench-to-bedside,” research involves expediting the translation of these
scientific discoveries in to clinical practice.
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