Exhibitor Showcaseat

14 February 2012

3:40 PM in Room 266

What We Do

Established and Integrated provider of

Manufacturing & Development services,

for Finished Dose Forms & APIs

Global network of six development & manufacturing sites

Annual turnover ~ $260M

Staff of ~ 1300

Timeline

2004 // 2007 2008 2009 2010 2011 2012

BASF Cramlington, UK

Abbott Queenborough, UK

R5 Pharma Nottingham, UK

UCBZwickau DE

Monheim DE Pianezza ITNottingham, UK

Cramlington, UK

Queenborough, UK

Monheim, DE Zwickau, DE

Pianezza, IT

Business Units

Phase I Phase II Phase III CommercialPre-clinicalLead Selection

APIKilo Lab Pilot Plant Scale-up Manufacturing

Formulation Development Screening Development Clinical Supply

Formulated Products

Bulk Packaging Distribution

Pharmaceutical Support Services

QA RA CTDClinical

Active Pharmaceutical Ingredients

Development

Route selection, optimisation, process R&D, DOE

Reactions to 50L scale

5L Hastelloy® filter drier

-20 ºC to 150 ºC reaction temperatures

Distillation, hydrogenation, RC1, DSC

cGMP preparation for preclinical & early clinical

Scale Up

Process scale up to pilot plant & commercial scale

Glass-lined reaction vessels to 250L volume

Hastelloy® filter drier with glove box isolation technology

-20 ºC to 150 ºC reaction temperature capability

Campaigns from 10kg to 100kg

Clinical supply or small scale commercial manufacture

Manufacturing

2 computer controlled multi-purpose plants

Reactors: 1m³ to 10m³Filter driers: 1m² to 6m²Blender driers: to 1m³Temps: -15 ºC to 150 ºC

Home Office licenses for manufacture & handling of controlled substances and highly potent drug classes

Approvals to supply into US & other major markets

Bespoke software solutions for complex inter-reaction chemistry

High vacuum distillation & drying equipment

Clean room facilities for finished product handling, milling

Commercial scale pressure hydrogenation, hydrochloric acid gas & bromine technology

Potent & Controlled Substances

Capable of handling SafeBridge® category 3

450 liter scale, filter dryer, glove box charging

Preparative HPLC system

Controlled drug licences for Schedule I - IV

Manufacture from laboratory through commercial scale

Secure storage for intermediates & APIs

Quality & Compliance

FDA MHRA ISO 14001 ISO 9001 Licence of Possession

of Controlled

Drugs

Licence to Manufacture Controlled

Drugs

CramlingtonUK

√Jun-06

√Nov-08

√ √ √Schedule 1,

2, 3, 4

√Schedule 2,

3, 4

QueenboroughUK

√2010

√2010

√ √Schedule 2,

3, 4

√Schedule 2,

3, 4

Formulation Development

Formulation DevelopmentCapabilities

Formulation, process and analytical development

Clinical trial manufacture

QP release

Expert in Sterile, Topical, and Oral dose forms

Manufacture for Phase I & Phase 2 Clinical Trials

IMP & Specials licensed facility

Oral / Topical

Fourteen GMP flexible manufacturing rooms

Positive Pressure Corridor with100% fresh intake

Plumbed cleaning systems

Temperature / Humidity17°C – 23°C35%RH – 65%RH

Manufacturing equipment for:

• Tablets up to 100,000/hour• Coated tablets 500g – 12kg• Capsules 200 – 3,000/hour• Powders up to 50kg• Creams up to 20kg• Ointments up to 20kg• Oral liquids up to 500 litres

SterilesAseptic filling, terminal sterilisation & lyophilisation services

Formulation & process development

Manufacture for Phase I & II Clinical Trials

Solutions / Suspensions / Powders

Aseptic Filling Sterilisation by filtration, dry & wet heatFreeze Dryer in Grade A UDAF100% visual inspection

Vial Data• Sizes: 2ml to 50ml• Aseptic fill batch size 2ml vials is 1800 vials• Aseptic fill batch size 50ml vials is 650 vials• Lyophiliser size 770 x 2ml vials

Pre-filled syringes

Infusion bags

Spray Drying

Bench-top Buchi*:• Upto 5l • 100mg – 100g spray-dried material (efficiency dependent)• Flow rate – up to 1 l/hr

Niro Mobile Minor*:• Upto 50l• 100g – 10kg (efficiency dependent)• Flow rate – upto 6.5l/hr

Inert handling available - process under N2

*Material dependant

Quality & Compliance

MHRA IMP Manufacture & Testing of Steriles

MHRA IMP Manufacture & Testing of Non-Steriles

Home Office Controlled

Drugs Licence

MHRA Specials Licence

General Commercial

Licence

Cytotoxic Commercial

Licence

NottinghamUK

√Dec-07Mar-09Apr-11

√Mar-07Mar-09Apr-11

√Apr-07

√Jun-10Apr-11

√Apr-11

√May-11

Formulated Products Manufacture

Timeline

2004 // 2007 2008 2009 2010 2011 2012

BASF Cramlington, UK

Abbott Queenborough, UK

R5 Pharma Nottingham, UK

UCBZwickau DE

Monheim DE Pianezza ITNottingham, UK

Cramlington, UK

Queenborough, UK

Monheim, DE Zwickau, DE

Pianezza, IT

Bulk Formulation & Packaging

Manage complexity

Quality ingrained in our culture

Proven technical transfer procedures

Cost effective processes

Global supply chain

Capabilities

Technical Capability Capacity (per annum)

Wet granulation - low shear, high shear, fluid bed

> 1000 tonnes

Tablet production - single, bilayer > 4 billion tablets

Encapsulation > 1 billion capsules

Liquids - temperature non-critical 2 million litres

Liquids - temperature critical 300,000 litres

Blister packing 300 million packs

Bottle packing - tablets & granules 15 million bottles

Bottle packing - liquids 30 million bottles

Terminal sterlisation 25 million ampoules & vials

Additional CapabilitiesGranulation / Drying - vacuum, solvent based, fluid bed, blending

Tableting - bilayer, multiple lines, B&D tooling

Potent Manufacture – to SafeBridge® Category 3 solid dose

Coating - actives, controlled release, pellets

CTM Support – encapsulation, tableting

Packaging - in-line printing, cold chain, devices, patches

Other technologies - sachet/bottle filling, device assembly

Quality & Compliance

FDA MHRA Multi Region Supply

Japanese Supply Line

QP Release EU Approved

QueenboroughUK

√ √ √ √ √ √

MonheimDE

√ √ √ √Local German

Health Authority

ZwickauDE

√Inc. Korean

FDA

√ √ √Local German

Health Authority

PianezzaIT

√ √ √ √Local Italian

Health Authority

Pharmaceutical Support Services

Quality ServicesRegulatory AffairsAnalytical ServicesSupply Chain & DistributionArtwork Services

The Aesica Offer

An Established and Integrated contract manufacturing and development organisation

Delivering rapid, cost effective & compliant solutions

Providing our customers with assurity of supply

Our expertise delivers your peace of mind

Meet Us in 2012

informEx Booth #1606DCAT

CPhI Japan

Interphex

Bio International

CPhI China

ChemOutsourcing

Contract Pharma

CPhI WW

AAPS

www.aesica-pharma.com

Meet Us in 2012

informEx Booth #1606DCAT

CPhI Japan

Interphex

Bio International

CPhI China

ChemOutsourcing

Contract Pharma

CPhI WW

AAPS

www.aesica-pharma.com