iinformex 2012 showcase presentation
DESCRIPTION
Summary of Aesica Pharmaceuticals, presented at the informEx Showcase, February 2012TRANSCRIPT
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