Glasgow, UK FACTSHEET Sterile Fill Finish and Formulation Development & Clinical Trials Manufacturing At Aptuit’s Glasgow facility, specialists in sterile dosage forms deliver • Analytical and Ancillary Services liquid and lyophilized formulation development, complemented by – GMP release testing GMP sterile manufacturing facilities that include lyophilized and – GMP product stability cytotoxic products. Our scientists deliver innovative and quality – QP release solutions for Pharmaceutical Sciences programs. The Glasgow site – QA support and consulting has been part of the Aptuit family since 2007, when it joined the – Labeling/packaging and storage/distribution organization as part of the Evotec acquisition. Site Activities The pharmaceutical sciences delivered from the Aptuit Glasgow facility fall into three key categories: • Preformulation and Formulation Development, including analytical development services for method development, transfer and validation Why Aptuit? The fact that Aptuit can deliver both sterile fill/finish services and formulation development services within the same facility provides significant benefits to clients. Aptuit can manufacture, release, package and ship clinical materials in as few as six weeks. Aptuit’s capabilities in Pharmaceutical Sciences span – Liquid & lyophilized formulations of small organics, peptides, proteins and nucleotides a wide range of dosage forms and delivery systems. Our – Solubility & stability enhancement scientists in the industry – are what make this possible. Our – Proof of concept stability scientists can deliver quality solutions for your Pharmaceutical – Assessment of solution stability in infusion system Sciences program using innovative and flexible solutions. – Small scale prototype batch manufacturing capabilities for liquid and lyophilized products (utilizing the FTS Lyostar II lyophiliser system). Quality Assurance • Manufacture of Sterile Products for Clinical Trials people – some of the most experienced pharmaceutical The Glasgow site has high standards for quality and regulatory compliance. The site utilizes a Pharmaceutical Quality Management – Liquid fill batch (up to 10,000 units) aseptic production; highly potent and non-cytotoxic compounds for Phase I and II studies System that meets EU GMP standards. In addition to maintaining a – Primary packaging (glass vials, ophthalmics, nasal sprays) regularly audited by clients and inspected by government regulatory – Liquid & lyophilized filling agencies; no critical or – Ability to develop formulations for NCEs through the transfer of existing manufacturing processes into the Glasgow facility major findings have been high standard of internal quality processes and procedures, the site is cited. Aptuit Glasgow is licensed for Investigational Medical Products. APT/FACT/GLAS/01/14/V004 Glasgow, UK FACTSHEET Sterile Fill Finish and Formulation Development & Clinical Trials Manufacturing Formulation Development Services Sterile Manufacturing Services Liquid Formulation Terminally Sterilized and Aseptic Filling, with or without Freeze Drying • Formulation Type • D edicated Clean Room Suites (Grade D to A) for highly potent and non-Cytotoxic compounds – Parenteral – Oral – Ophthalmic – Nebulised • Solubilization Methods – pH/organic solvents – Organized into two units with three clean room suites and two dedicated lyophilizers for non-cytotoxic and cytotoxic products. Each unit includes a component preparation room, holding area for sterilized components, compound preparation area, and finished product filling/crimping area. – Cyclodextrins – Manual (flexible) manufacturing processes utilizing disposable contact parts – Surfactants – Process qualification covers 2 to 100ml vials – Liposomes/lipids – Up to 40L maximum batch volume • S tability Data Assessment using Arrhenius Model for predicting drug formulation shelf life • Sterile Manufacturing Expansions in 2012 • Compounding Process Development – Upgraded Unit 2 filling suite, with a larger class II manual filling cabinet • Sterilization Method (filtration, autoclave) – Upgraded component preparation areas • Finished Product Stability – New automated filling machine, Flexicon FPC 50 with Restricted Access Barrier System; increases liquid batch size to 10,000 units and lyo batch size to 6,000 2ml vials and 3,000 10ml vials Lyophilized Formulation • T hermal Properties of Formulation – Freeze drying microscopy – Differential Scanning Calorimetry (DSC) • S election of Lyophilization Excipients (cryo/lyo protecting properties) • D evelopment of Lyophilization Cycle (FTS Lyostar II) • Optimization of Cycle parameters – New tray vial washer that aligns vial tray system with auto-filler recently installed as part of major upgrades and expansion investment offering continuous Grade A containment for the primary packaging material through the manufacturing process. Analytical Services HPLC Analysis • Method acquisition for assay and impurity analysis • HPLC Method Development – Reverse phase – Normal phase (including chiral assay development) – Size exclusion chromatography (molecular weight distribution) • Assessment of Stability of Reconstituted Solution • Detection Systems (UV, DAD, RI, ELSD) • Finished Product Stability • HPLC Method Validation (full ICH or partial) APT/FACT/GLAS/01/14/V004 Glasgow, UK FACTSHEET Sterile Fill Finish and Formulation Development & Clinical Trials Manufacturing Analytical Services, continued Uncommon expertise. Exceptional results. Protein Analysis Aptuit provides early to mid-phase drug development solutions by • Protein assay (standalone UV) applying scientific excellence, outstanding service and a team of some • Gel electrophoresis (SDS-PAGE) of the foremost scientific professionals in the industry. These drug • Isoelectric focusing (IEF) discovery and development professionals offer proven experience • Size exclusion chromatography (molecular weight distribution) in key therapeutic areas. They share a legacy of success, having advanced a large number of molecules efficiently, expeditiously and Other Analysis economically, from early discovery through clinical development with • Gas chromatography low attrition rates. • Mass spectrometry It is our uncommon expertise that allows Aptuit to identify the unexpected, mitigating risks and maximizing promising possibilities, ensuring exceptional results through an open, transparent climate of trust that our clients can count on. Aptuit’s comprehensive drug development services include: • • • • • Drug Design & Discovery Preclinical Biosciences API Development & Manufacture Solid State Chemistry Pharmaceutical Sciences • Aptuit INDiGO® - fast track to IND program • Integrated Drug Discovery & Development For information about Aptuit’s services, please contact us: in Europe: +39 045 821 9333 in the US: 855-506-6360 email us at: [email protected] www.aptuit.com APT/FACT/GLAS/01/14/V004