For peace of mind from development to commercial supply aesica-pharma.com weshouldtalk@aesica-pharma.com @aesica CorporateBroEng_v2 0814 @ Aesica 2014
Your full service CDMO Our vision: To be the number one supplier of APIs and finished dose products to the pharmaceutical industry Innovative. Integrated. We work of the with8 10 world s Finished dose and API Aesica: largest pharmaceutical companies the strongest link in your supply chain International. The Aesica story is one of success and stability. In ten years we have expanded our network across Europe, Asia and North America. With a series of world class development and manufacturing facilities, we have become a trusted ally to a diverse range of organisations in the pharma marketplace. We re proud of our long-standing partnerships with multinational, mid-sized and virtual pharma companies. The calibre of our customers speaks volumes about us. We are a chosen CDMO to eight of the world s ten largest pharmaceutical companies and GMP partner to a number of Europe s most prominent universities. As a fully integrated CDMO, we have a team of highly accomplished specialists with the expertise to surpass our customers expectations. Our customers rely on expert support and flexibility at all stages of the product lifecycle, from early stage development through to commercial manufacturing services and supply. Delivering the assurance of outstanding quality is absolutely fundamental to us. Customers gain confidence from our exemplary record of meeting stringent regulatory standards set by the FDA, EMA, PMDA and ANVISA. We re proud to stand out as the CDMO that delivers flexibility and peace of mind in a fast-moving market that demands innovation and service excellence.
Commercially competitive at every stage Lead selection Pre-Clinical Phase I Phase II Phase III Commercial From our customers in universities, virtual pharma, biopharma and the world s leading multinationals, we offer the same formula: When we ask our customers why they choose Aesica, they tell us we meet their exact production and quality standards at a competitive cost. Our customers tell us we re agile. They say we re the CDMO they contact when they have a challenge that requires an innovative and customised approach. We pride ourselves on our agility and flexibility, be it a high volume manufacturing contract or a pilot project. Irrespective of size, we re used to short lead times or complex projects. You ll discover this first hand when you talk to us. Friendly experts of the highest calibre Facilities we expand to meet pharma s future needs Peace of mind that we believe is second to none
Early stage development From lead candidate selection to Phase II clinical trials API development When a customer comes to us with a concept, we produce the low volume API needed to develop the initial formulation for pre-clinical, Phase I and Phase II clinical trials, including potent and controlled drugs. We then develop and optimise the synthesis to convert a concept into a process that s safe, reproducible and commercially viable. Capsules Suspensions Creams Tablets Liquids Inhaled Ointments Our QPs 50+ clinical batches release every year Biotechs, virtual pharma companies and universities respect our formulation capabilities and tap into our experienced team of specialists to support their formulation challenges across topical, oral and inhaled dosage forms. We excel in taking an initial concept and working with our clients to develop a robust formulation to submit to Phase I clinical trials. We offer objective advice and expert guidance which, according to our customers, gets them to clinical trials faster and more economically. Plus, our regulatory support team can manage clinical trial documentation on your behalf. Pre-formulation We invest our years of expertise to evaluate how we can manipulate your API to develop the optimum drug delivery system. Formulation Using data gathered at the pre-formulation stage, we propose the optimum formulation and manufacturing method. Prototype batches are then developed to conserve your valuable API, while still generating invaluable data for further analysis. Stability testing We test all formulations at our in-house analytical labs to refine and optimise the product before proceeding to clinical trials. Manufacture and QP release We produce clinical trial materials in our cgmp compliant facility before our in-house QPs release products for clinical studies.
Late stage development From Phase II to pre-launch On completion of Phase II clinical studies, we provide the expertise and facilities to prepare for Phase III, product launch and Phase IV. Robust track record of audit excellence FDA EMA and approved facilities Scaling up API and drug product Whether providing larger batch sizes for Phase III clinical trials or manufacturing drug products ready to launch, we have the manufacturing and regulatory expertise to take API and drug products to the next stage of the development process. Prepare to launch Together with our regulatory affairs team, our expert packaging, artwork and distribution services form part of a complete end-to-end solution to get new products to the marketplace quickly and economically. Our award-winning in-house design team creates compliant packaging and patient information materials that meet both regulatory and marketing requirements. We also offer market-leading packaging fulfilment services including bottles, blisters and sachets. Our specialist distribution capabilities mean we can help our global customers be first to market, even in cold chain conditions. Tech transfer We can manage the seamless transfer of API or finished products to and from our facilities at any stage in the product development lifecycle. All of which means you can proceed to launch, through API manufacture and pre-commercial validation, with complete confidence. We provide: European distribution QP release Cold chain capabilities Packaging and artwork Tech transfer cgmp scale up Process development and optimisation We can efficiently establish and validate the optimum processes to take API from kilo lab to commercial scale, working closely with our customers via a dedicated project manager. With API supplies in place, we offer manufacturing facilities of the highest calibre to produce the finished drug product, be it liquid, solid dose or a controlled drug.
Commercial supply From launch to lifecycle management Our integrated network of world class facilities and local experts puts us in a strong position to optimise product lifecycles from development through launch towards maturity. Continuous tablet processing We offer flexible capacity, room to grow and the ideal infrastructure to handle complex API, manufacturing and packaging projects. Supply Import chain management service Packaging updates Manufacturing for the life of your product Our commercial scale manufacturing facilities provide customers with ongoing access to new processing technologies, flexible assets and specialist expertise that deliver a high return on their outsourcing investment. Our technical and manufacturing experience ranges from sublingual, bilayer and controlled release tableting to device assembly, hard gel encapsulation, oral liquids, pellets and terminally sterilised injectables. We re licensed to manufacture controlled drugs and adept at handling potent drugs and API to SafeBridge category 3. Our API experience comes into its own at commercial scale. We re one of the leading contract manufacturers across patented and generic drugs, managing multi-tonne projects to strict cgmp standards. Commercial scale drug product manufacturing Variation strategy and submission Bulk API manufacture Potent capabilities to 3 SafeBridge category Licensed controlled to handle drugs
Your full service CDMO from development to commercial supply Packaging excellence Pouches Medical Devices Sachets Blisters Bottles Oral Injectables liquidstablets Contract pharmaceutical packaging Our customers take advantage of our wealth of packaging experience encompassing sustainable materials, 2D Data Matrix capabilities and anti-counterfeit innovations. We produce packaging in more than 50 languages that is fully compliant with regional legislation across Asia, Europe and beyond. As legislation evolves, we re well placed to advise on the necessary changes to packaging, labelling and design to ensure 100% compliance. Lifecycle guidance Our regulatory team offers expert support in planning variation strategies to take advantage of diverse applications for patented formulations. We also plan and write submissions for our customers developed or developing markets. For products manufactured outside the EU, our import service is an end-to-end solution enabling successful marketing in Europe; including regulatory support, packaging services, QP release and local distribution. 10 years of outstanding compliance in high containment Aesica has x grown 10 in the last ten years Our strong track record in manufacturing commercial scale API and drug products means we hold long-standing contracts with some of the world s most prominent pharma companies. Long after product launch, or following tech transfer to our facilities, we continue to refine our manufacturing processes, ensuring we deliver the most efficient and economical solution for our customers continued commercial success.
A world of expertise United Kingdom Newcastle Cramlington Nottingham Queenborough We operate a European network of finished dose and API facilities, supported by our team of global sales representatives. North America Europe India China Japan Around the world, across all Aesica sites, our customers can choose from a diverse range of complementary services to add value to the development and manufacturing process. From regulatory support to QP services and supply chain management, we customise our services to suit the project at hand. South America And this is just thestart. Germany Monheim Italy Zwickau Pianezza Peace of mind on a global scale We are constantly exploring new opportunities to expand our network and the technologies we offer via acquisitions and strategic alliances. aesica-pharma.com Visit weshouldtalk@aesica-pharma.com Key Headquarters Development and manufacturing facilities Sales representatives Monheim, Germany Integrated packaging and distribution capabilities including artwork services, packaging of blisters, bottles, sachets and pouches. Zwickau, Germany Bulk production site excelling in solid dose forms and offering a full spectrum of analytical and development capabilities. Cramlington, UK With capabilities in managing potent and controlled APIs, our API development and commercial scale manufacturing is equipped with development labs, kilo labs and pilot plant capabilities. Queenborough, UK Commercial scale manufacture of oral, solid and liquid finished dose forms as well as high potency APIs, with anesthetic API and bottling capabilities. Nottingham, UK Specialising in formulation development, the facility provides pre-clinical and early phase clinical trial support. Pianezza, Italy Commercial scale manufacture of liquid products: both terminally sterilised injectables (vials and ampoules) and oral liquids. Blister packaging with fully automated flexible packaging lines and analytical capabilities. @aesica