THE WHOLE
SUPPLY CHAIN.
SIMPLIFIED.
QUALITY.
DELIVERED.
FASTER.
HOW AESICA CAN ADD
VALUE AT EVERY STAGE
BY CONSORT MEDICAL
By simplifying the supply chain, Aesica offers you a tried and trusted
single source from drug and device development (via Bespak) to
delivery to get you to market sooner, more cost-effectively and with
reduced risk.
Aesica’s full service, end-to-end pharmaceutical development
and manufacturing solution comprises capabilities in formulation
development for both API and finished dose, manufacturing at all scales
and packaging services.
By bringing Aesica and Bespak together, Consort Medical aims to
become your leading customer-centric CDMO, delivering exceptional
value to the supply chain from early stage development of drugs and
devices to full commercialisation.
LIFESAVING PRODUCTS
QUALITY ASSURANCE
BESPAK DEVICES
DRUG
DISCOVERY
INNOVATION ALL THE WAY
DRUG
DEVELOPMENT
API
MANUFACTURE
BESPAK DEVICES
DEVICE FEASIBILITY,
CONCEPT AND
INITIAL DESIGN
DEVICE DETAILED
DESIGN AND
DEVELOPMENT
DRUG FORMULATION
DEVELOPMENT
CUSTOMER
CUSTOMER
AESICA API AND FINISHED DOSE
AESICA API AND FINISHED DOSE
BESPAK DEVICES
BESPAK DEVICES
DEVICE PILOT,
CLINICAL AND LOW
VOLUME PRODUCTION
DEVICE HIGH
VOLUME COMMERCIAL
PRODUCTION
DRUG/DEVICE
ASSEMBLY
(FILL/FINISH)
FORMULATED PRODUCT
MANUFACTURE
AESICA API AND FINISHED DOSE
AESICA AND BESPAK
Our international network offers you a world of expertise from API
development to commercial manufacture – and beyond – supported
and managed anywhere in the world.
HERE TO HELP
ANY SPECIFIC REQUIREMENTS OR QUESTIONS?
JUST ASK.
AESICA
+44 (0) 191 218 1960
enquiries@aesica-pharma.com
www.aesica-pharma.com
@aesica
BESPAK
+44 (0) 1553 691 000
enquiries@bespak.com
www.bespak.com
@Bespak_
Aesica is a leading pharmaceutical contract development
and manufacturing organisation (CDMO) for both APIs and
finished dosage forms. We can take your product through to
commercialisation – or provide specific services at any stage – with
processes customised to suit your company, output and brand vision.
ALWAYS
DEVELOPING.
FROM API TO FINISHED
DOSE AND BEYOND
ANY SPECIFIC REQUIREMENTS OR QUESTIONS?
JUST ASK.
AESICA
+44 (0) 191 218 1960
enquiries@aesica-pharma.com
www.aesica-pharma.com
BESPAK
+44 (0) 1553 691000
enquiries@bespak.com
www.bespak.com
www.aesica-pharma.com
SINGLE SOURCE FOR
DRUG DEVELOPMENT
AND MANUFACTURING.
API MANUFACTURE
FINISHED DOSE MANUFACTURE
Combined with our development and supply services, Aesica can take your
API from early clinical trials scale, all the way to commercial manufacture.
As a full service CDMO, we offer a broad variety of capabilities
in finished dose manufacturing and packaging. Our extensive
network of manufacturing facilities can take you to commercial
scale finished dose seamlessly.
Six cGMP manufacturing plants are dedicated to the commercial scale production
of APIs and GMP intermediates, operating from kilo to multi-tonne scales.
This gives us the capability to manufacture licensed and generic, potent and
controlled drugs to commercial scale.
We’re ahead of the curve on important developments such
as continuous tablet manufacturing; while actively looking
to innovate further and give our customers a clear,
competitive edge.
Our experienced Regulatory Affairs Team routinely submits regulatory filings
(i.e. DMF, CEPs etc) to the relevant authorities around the world and can guide
you through the ever-changing regulatory environment.
PACKAGING AND SERIALISATION
Aesica offers a quick turnaround for primary and secondary
packaging for numerous dosage forms, including blister,
bottles, pouches, liquids, injectables and syringes. Through
serialisation, we can reliably and robustly check your products
and batches all the way through the packaging and distribution
process. Alongside technical, complex verification systems, we
can issue fully compliant labelling, artwork management and
graphic design services (across regulatory environments and
national/international authorities).
API DEVELOPMENT
FINISHED DOSE DEVELOPMENT
With over 30 years of manufacturing expertise and
significant experience as a contract manufacturer,
Aesica is a global leader in the production of generic
APIs in areas such as antidepressants, narcotics and
anaesthetics.
Aesica offers a breadth of finished dose expertise across
our established sites throughout your product lifecycle.
Quantities start from grams to hundreds of kilograms
in our flexible development facilities, which enable the
manufacture and isolation of potent and controlled
drugs. Operating to full cGMP standards, the flexible
kilo lab handles multi-stage complex processes with
batch sizes from 10g to 5kg. Our modern pilot plant
delivers 10kg to 100kg batch sizes and was purposebuilt to handle a broad range of complex chemistries
to support your clinical and small-scale commercial
demands – via safe processes that support modern
regulatory requirements.
EARLY STAGE
SERVICES
Starting with formulation development and optimising
as we scale up across the lifecycle of your product, our
end-to-end capabilities ensure a smooth transition from
clinical development to the commercialisation of your
product.
•
Pre-formulation
•
Pre-clinical trials
•
Phase I and II clinical trials
•
Potent and controlled drug capabilities
•
Process research and development
•
Stability testing
•
QP release
•Technology transfer
•
Support services
•Continuous improvement
•Generic APIs
•Phase III
•Product launch
No project is too big or too small. We can help navigate
the complex development stage and regulatory
environment faster – and more economically – to prepare
you for commercial manufacturing.
FORMULATION DEVELOPMENT
Our API and pre-formulation insights
offer a development service for new
and existing molecules – including
formulation development in solid,
oral liquid, semi-solution, solution
and granular forms.
CLINICAL TRIAL SUPPLY
We can lead through Phase I–III
trials, traditional or adaptive clinical
supply design.
SMALL SCALE
COMMERCIAL SUPPLY
From bulk materials for clinical
studies to small volume and
commercial production.
KEY CAPABILITIES
•Wet granulation, tablet
production and encapsulation
•Liquid manufacturing and
bottle packaging
•Terminal sterilisation
(ampoules and vials)
• Continuous manufacture
•Potent and controlled drugs