acino cmo services · • pellet layering in fluid bed process • coating of pellets • fluid-bed...
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Acino Contract Manufacturing OverviewIntroduction to Acino Contract Manufacturing ServicesJuly 2019
Acino Key Figures
Acino at a Glance
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Headquartered in Zurich, Switzerland, Acino develops, manufactures and commercializes high quality pharmaceuticals for the benefit of patients
Acino takes leadership through commercial excellence in selected emerging markets with own Acino brand
Middle East, Africa, CIS, Russia and LATAM
Swiss manufacturing sites serve a variety of B2B customers
Out-LicensingAcino products sold in European and other markets by a broad range of leading pharmaceutical companies
Contract ManufacturingCustomers’ products are manufactured and packaged by Acino, often with a full-service business model
311 m€Sales in 2018
~1’950Employees globally
>75%Sales in Emerging Markets
400Employees in Switzerland
75% : 25%Sales split B2C : B2B
3 Manufacturing sites (CH, EE, UA)
183 YearsOf Swiss company history
100%Privately owned by Avista Capital & Nordic Capital
Where we deliver our products to
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Corporate HeadquartersRegional OfficesProduction and PackagingMarket Authorization office, GermanyCommercial operations English-speaking AfricaCommercial operations Middle East, North/French-speaking AfricaCommercial operations Latin AmericaCommercial operations Ukraine/CISCommercial operations RussiaOut-licensing and contract manufacturing
Technology we’re proud of
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We have the know-how, the technology and the infrastructure tosupport you achieving your needs.
Our in-house engineering team has the experience and know-how tobe able to adapt or bring in technology solutions quickly.
We continue to invest in a range of technologies, capabilities andcompany structures to stay competitive.
>50 Years experience in pharm. manuf.
>60Countries being supplied with our products
10multi-national pharma customers
27small-medium sized pharma customers
Quality in all we do
100%Passed audits & HA inspections
99.6%Batch acceptance in 2018
10+2 Customer + Health Authority audits in 2018
224Quality employees in 2018
Our Quality Mindset is rooted in our Swiss heritage.
We meet and exceed the highest standards for our products, as well as using our own quality culture to continually improve our offer.
Our global Quality strategy that covers all aspects of our business, from the relationships we develop to the products we deliver.
Our Quality Policy greets every visitor and employee in every site entrance in Acino.
Our global CMO presence
Liesberg, Switzerland
Aesch, Dornacherstrasse, Switzerland
Põlva, Estonia
Kiev, Ukraine
Manufacturing
ManufacturingPackaging
ManufacturingPackaging
Packaging, Logistics,Warehouse
AL
AD
AE
AU
Aesch,Pfeffingerring, Switzerland
Packaging, Logistics,Warehouse
AP
CH EE UA7
Zurich, Switzerland
Headquarters
HQ
Our OSD Center of ExcellenceSince many decades Acino has been manufacturingpharmaceuticals. With many successful in-housedevelopments, we have gained in-depth knowledge inbringing products from development to commercializationand expertise in solid dosage forms by constantly optimizingand improving our processes.
~130Employees
~55Employees in production
3’400 m2Production area
10’500 m2Total site area
33 kmDistance to Basel
3 bnBulk unit capacity
Overview Health Authority Audits: Liesberg, Switzerland
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Regulatory Authority Date of inspection Country / Region
Ministry of Health of the Republic of Belarus May 2019 Belarus
Ministry of Industry and Trade of the Russian Federation January 2019 Russia
RHI /Swissmedic February 2017 Switzerland
RHI /Swissmedic March 2014 Switzerland
RHI /Swissmedic December 2011 Switzerland
Executive Board of the Health Ministers’ Council January 2011 Gulf Cooperation Council
• The Liesberg facility is routinely inspected by both its international clients and its local Health Authority – Swissmedic
• The facility is approved for all European countries, Canada, New Zealand and Australia through mutual recognition and ships to multiple destinations such as, Europe, Asia, MEA, South America etc.
• The facilities have received accreditation by the Japanese Ministry of Health, Labour and Welfare.
• Russian audit (GISK) in January 2019 – approval outstanding
Our Packaging and Logistic Site in EstoniaOur Estonian packaging site in Põlva offers our customerspackaging services for OSD’s at the highest flexibility interms of order volumes, costs and delivery performance,while applying highest Acino quality standards. From largescale down to small manual packaging order volumes, ourEstonian team is capable to transform their flexibility to acustomer’s benefit.
~62Employees
42%Employees with higher education
1’176 m2Packaging site area
5’100 m2Total site area with technical area and warehouse
228 kmDistance Tallinn to Polva
15 mioPacks packaging capacity
Health authority inspections, customer &internal audits, Põlva, Estonia
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Competent authority/ corporate audits Date of inspection Country / Region
Veterinary and Food Board December 2013 Estonia
Veterinary and Food Board November 2014 Estonia
State Agency of Medicines January 2015 Estonia
Veterinary and Food Board November 2015 Estonia
Veterinary and Food Board September 2016 Estonia
State Agency of Medicines February 2018 Estonia
Veterinary and Food Board March 2018 Estonia
Customer audit Date of inspection Comments
MNC Company 1 – external audit: initial qualification September 2017 Acceptable
Acino (AL) – initial assessment audit April 2018 Acceptable
MNC Company 2 – qualification audit June 2018 Acceptable
MNC Company 3 – qualification audit October 2018 Acceptable
MNC Company 4 – qualification audit February 2019 Approved
GMP-certified manufacturing and QC and R&D in UkraineOur modern production site in Kyiv, was planned and built in accordance with GMP ЕU guidelines; applying the highest Acino quality standards. We manufacture and package products for the Ukrainian market as well as export to CIS countries: 105 MA’s in Ukraine, 86 MA’s in CIS. Our plant is equipped with state-of-art technology and our warehouse complex has a capacity ~2,700 pallets.
317Employees
1 bnTablet capacity
1 bnCapsule capacity
2’150m²Total production site area
June 2019 EU GMP Audit planned
30 mioPacks capacity
Acino CMO Offering - Overview
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Granulation/Pelletization
• Wet (aqueous & organic), dry and melt granulation
• Fluid-bed & high shear granulation
• Direct compression• Extrusion /
Spheronization• Pellet layering in fluid
bed process• Coating of pellets• Fluid-bed and tray
drying• Sieving / blending
Finished Dosage Form
• Modified-release tablets (MUPS & Matrix tablets)
• Film coated- or dispersible-tablets
• Printed tablets• Modified release
capsules• Micro-tablets in
capsules• Controlled substance
& broad-spectrum antibiotics
Primary Packaging
• PVC//Alu• PVC/PVDC//Alu• PVC/PE/PVDC//Alu• Alu//Alu• Controlled substances
packaging (AP & AE)• Packaging of potent
OSDs• Bottles (glass, plastic,
aluminium) with different Caps (push-on, screw, snap safe, desiccant capsules)
• Unit dose blister
Secondary Packaging
• Standard secondary packaging (for packs &
• bottles)• PIL-packages• Artwork management• Serialization &
aggregation • Warehousing &
logistics
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AL AL
Our flexibility – your choice
Due to our flexibility, our customer can choose the right set-up for their supply chain. Our team will assist our customers to choose the perfect solution.
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AL AE
Our flexibility – your choice
Due to our flexibility, our customer can choose the right set-up for their supply chain. Our team will assist our customers to choose the perfect solution.
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AP
Our flexibility – your choice
Due to our flexibility, our customer can choose the right set-up for their supply chain. Our team will assist our customers to choose the perfect solution.
• Pellet manufacture and coating• By extrusion & spheronization• Pellets layering on starter cores• Pellets coatings with functional and/or non-functional films
• Wet granulation:• Fluid Bed and High Shear Granulation• Aqueous & organic granulation (Isopropanol & Ethanol)
• Dry granulation / Roller compaction
• Melt granulation / Cooling with dry ice
10fluidized bed granulators in CH
350 tof pellets & granulate produced in 2018 (CH)
Granulation / Pellet manufacture
available at
AL AUAP AE
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• Focus on hard-to-make generics & niche-technologies
• Focus on suspension layering & modified-release dosage forms
• Strong expertise in narcotics & broad-spectrum antibiotics production
• Our offerings:• Modified-release Tablets (MUPS & Matrix Tablets)• Film- or Dispersible- Tablets• Printed Tablets• Modified-release Capsules (MUPS)• Capsules• Micro-tablets in Capsules
available at
AL AE AU
Bulk Production
AP
3 bnbulk units capacity in CH
up to 900 ktablets / hr
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• Small scale to large scale batch sizes (50’000 – 4’000’000 units)
• Clinical trial material and Small scale commercial manufacturing
• Support in late stage development & product launch
• Broad and current tech transfer expertise, process optimization
• Our offerings:• Granulation / pelletization• Encapsulation• Compression• Coating
300 m2floor space
2 - 2’000 kgbatch size
available at
AL AUAP
Flexible scale
AE
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138 mioblisters packed in 2018
5’250 kmof aluminium foil used in 2018
available at
AL AE AUAP
Primary Packaging• Price competitive:
• High speed lines in AP for larger order quantities• Low-cost packaging in AE for smaller order quantities
• Transport to AE under GDP conditions and in full responsibility of Acino
• Our offerings:• PVC//Alu• PVC/PVDC//Alu• PVC/PE/PVDC//Alu• Alu//Alu• Controlled substances packaging (AP & AE) & packaging of potent OSDs (AP)• Bottles (glass, plastic, aluminum) with different Caps (push-on, screw, snap safe, desiccant
capsules)• Unit dose blister
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• Batch release according to customer wishes• CH batch release in AP• EU batch release in AE
• Transport to AP under GDP conditions and in full responsibility of Acino
• Serialization/UI & tamper evidence • Implemented and running in AP; standard Acino-wide implementation Nov & Dec 2018 • Tracelink data sharing
• Our offerings:• Standard secondary packaging (for packs & bottles)• PIL-packages• Artwork management• Serialization / aggregation• Clinical trials packaging
40.2 miopacks shipped in 2018
~1’175 kmhigh tower of all packs shipped in 2018
available at
AL AE AUAP
Secondary Packaging
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• Acino can be your full service CMO:
• Worldwide API, raw material and FDF sourcing, including supplier qualification
• Warehousing & distribution services
• Regulatory support
• Process optimization
• Additional QC Services for customers
2’303global registrations
300qualified suppliers in 2018
available at
AL AE AUAP
Additional Services
Liesberg & Aesch Quality ControlOur brand new Quality Control laboratories meet and exceedthe highest quality standards and requirements.We have know-how, technology and facilities to support youachieving your projects goals. Continuously investment in ourequipment with the latest technologies constantly increasesour capabilities.
1200 m2QC area
~50Employees in QC
29HPLC Instruments
6UPLC Instruments
2’196Samples analysedin 2018
25, 30 & 45° CStability chambers
Environment, health & safety
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Environment, Health and Safety (EHS) is an integral part ofgeneral management at Acino.
The role of EHS is to provide the required tools to complywith all regulations regarding occupational safety, hygieneand medicine, environment, legal compliance and corporatesocial responsibility.EHS ensures the appropriate application of these tools forsafe workplaces and, at the same time, respect of theenvironment. EHS supports Acino in taking all responsibilitiesof an employer to protect employee`s integrity andenvironmental resources for a sustainable future.
- 35%Less accidents within one year (2018)
OEL 1 - 3Level bulk manufacturing
- 30%Less rate of illness within one year (2018)
4’192 hInternal EHS training (2018)
EHS Politics
EHS Standard
Occ
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l Saf
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Occ
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l Hyg
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Occ
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l Med
icin
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Envi
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Lega
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plia
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Cor
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EHS System & Culture
Your partner from wish to productWhen you engage Acino, you are getting a true partner.
We think this starts with transparency and right expectations– before we go in to business together we make sure weunderstand your means in full. Our team will then proposethe best options.
We know how situations can change within a minute, so wecommit to highest flexibility in our offerings, services and inour every-day work to meet our customer’s demands &expectations
100%clarity on contact persons
100%commitment
1dedicated CMO Account Manager
up to 4status calls per month
Project Management that goes beyond
14transfer projects in 2018
~ 6 – 8 mduration of a packaging project
max. 1month from RFQ to offer
~ 12 – 18 mduration of a bulk project to finalization of validation
Our project management goes beyond the technicalrealization of your project: By assuring fairness andtransparency in our project proposal, we keep an eyeon your budget and timelines.
The key to a successful project is a good planning – westrive for close collaborations and open communicationwith our customers directly from the start to make itwork right from the beginning.
With our long-term experience in manufacturing of oraldelivery forms, knowledge of your target markets ®ulatory excellence, we can advise our customers inmany aspects to make your project a success.
Acino Transfer Projects
Project Preparation
Technical Feasibility Trials
Preparation Process Validation
Process validation
Stability Studies
Documentation
Registration Continuous Supply
Documentation exchange
Transfer Plan
Preparation Material No.
Ordering/Delivery of API/Excipients
Ordering of Tooling
Small Scale Technical Trials
Testing of Analytical Methods
Analytical Method Validation
Preparation Validation Plan
Signature round Documents
Ordering/ Delivery of API/Excipients
Production of Validation Batches
Analytics of Validation Batches
Packaging of Stability Samples
Stability Studies according ICH Guidelines
Validation Report
Stability Report
Submission to relevant authorities
Approval of authorities
9 - 15 months 3 - 12 months
Swiss time >99%OTIF target
1dedicated CMO Global Supply Chain Manager
99%batch release on time
370GDP European road transports with partners
As a Swiss company, we make a commitment to thedeadlines and we agree with our clients on OTIF KPIs.
In contract manufacturing there are times when weface challenges and it’s times like this that you need areliable partner.
If deadlines are ever at risk we will inform you as soonas we know and give you a clear overview of thesituation.
When we know, you know
Why work with us?
Swiss Quality Flexibility Technology & Know-How
Stable Supply Chain
Open, transparent & pro-active communication
Our Liesberg Team
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Our Estonia Team
Your contacts within Acino
Yuliyana ManolovaBusiness Development Contract Manufacturing
linkedin.com/company/255145/ acino.swiss/contractmanufacturing/ facebook.com/acino.swiss
Felix FaupelHead of Contract
Patrick FreyGlobal Key Account Manager
Contract [email protected]
Our Quality Our TechnologyOur FlexibilityYOUR BENEFITYOUR CHOICE
Thank you for your attention!