Acino Contract Manufacturing Overview - Introduction to Acino Contract Manufacturing Services
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Acino Contract Manufacturing Overview Introduction to Acino Contract Manufacturing Services July 2019
Acino at a Glance
Headquartered in Zurich, Switzerland, Acino Key Figures
Acino develops, manufactures and commercializes high
quality pharmaceuticals for the benefit of patients
Acino takes leadership through commercial excellence in 311 m€ ~1’950
selected emerging markets with own Acino brand Sales in 2018 Employees globally
Middle East, Africa, CIS, Russia and LATAM
>75% 400
Sales in Emerging Markets Employees in Switzerland
Swiss manufacturing sites serve a variety of B2B customers
Out-Licensing 75% : 25% 3
Acino products sold in European and other markets by a Sales split B2C : B2B Manufacturing sites (CH, EE, UA)
broad range of leading pharmaceutical companies
Contract Manufacturing
183 Years 100%
Of Swiss company Privately owned by Avista Capital &
Customers’ products are manufactured and packaged by
history Nordic Capital
Acino, often with a full-service business model
2
Where we deliver our products to
Corporate Headquarters
Regional Offices
Production and Packaging
Market Authorization office, Germany
Commercial operations English-speaking Africa
Commercial operations Middle East,
North/French-speaking Africa
Commercial operations Latin America
Commercial operations Ukraine/CIS
Commercial operations Russia
Out-licensing and contract manufacturing
3
Technology we’re proud of
We have the know-how, the technology and the infrastructure to
support you achieving your needs.
Our in-house engineering team has the experience and know-how to
be able to adapt or bring in technology solutions quickly.
We continue to invest in a range of technologies, capabilities and
company structures to stay competitive.
>50 >60
Years experience Countries being supplied
in pharm. manuf. with our products
10 27
multi-national small-medium sized pharma
pharma customers customers
5
Quality in all we do
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
100% 99.6%
Passed audits & Batch acceptance in
we deliver.
HA inspections 2018
Our Quality Policy greets every visitor and employee in
every site entrance in Acino. 10+2 224
Customer + Quality employees in
Health Authority 2018
audits in 2018
Our global CMO presence
Liesberg, Switzerland Põlva, Estonia
AL AE
Manufacturing Packaging, Logistics,
Warehouse
Aesch,
Dornacherstrasse, Switzerland Kiev, Ukraine
AD AU
Manufacturing Manufacturing
Packaging Packaging
Aesch,
Pfeffingerring, Switzerland
Zurich, Switzerland
AP HQ
Packaging, Logistics, Headquarters
Warehouse
CH EE UA
7
Our OSD Center of Excellence Since many decades Acino has been manufacturing pharmaceuticals. With many successful in-house developments, we have gained in-depth knowledge in bringing products from development to commercialization and expertise in solid dosage forms by constantly optimizing and improving our processes. ~130 ~55 Employees Employees in production 3’400 m2 10’500 m2 Production area Total site area 33 km 3 bn Distance to Basel Bulk unit capacity
Overview Health Authority Audits:
Liesberg, Switzerland
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
January 2019 Russia
Federation
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
9
Our Packaging and Logistic Site in Estonia
Our Estonian packaging site in Põlva offers our customers
packaging services for OSD’s at the highest flexibility in
terms of order volumes, costs and delivery performance,
while applying highest Acino quality standards. From large
scale down to small manual packaging order volumes, our
Estonian team is capable to transform their flexibility to a
customer’s benefit.
~62 42%
Employees Employees with higher education
1’176 m2 5’100 m2
Packaging site area Total site area with technical area
and warehouse
228 km 15 mio
Distance Tallinn to Polva Packs packaging capacityHealth authority inspections, customer &
internal audits, Põlva, Estonia
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
11GMP-certified manufacturing and QC and R&D in Ukraine Our 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. 317 2’150m² Employees Total production site area 1 bn 1 bn Tablet capacity Capsule capacity 30 mio June 2019 Packs capacity EU GMP Audit planned
Acino CMO Offering - Overview
Granulation/Pelletization Finished Dosage Form Primary Packaging Secondary Packaging
• Wet (aqueous & • Modified-release • PVC//Alu • Standard secondary
organic), dry and melt tablets (MUPS & • PVC/PVDC//Alu packaging (for packs &
granulation Matrix tablets) • PVC/PE/PVDC//Alu • bottles)
• Fluid-bed & high shear • Film coated- or • Alu//Alu • PIL-packages
granulation dispersible-tablets • Controlled substances • Artwork management
• Direct compression • Printed tablets packaging (AP & AE) • Serialization &
• Extrusion / • Modified release • Packaging of potent aggregation
Spheronization capsules OSDs • Warehousing &
• Pellet layering in fluid • Micro-tablets in • Bottles (glass, plastic, logistics
bed process capsules aluminium) with
• Coating of pellets • Controlled substance different Caps (push-
• Fluid-bed and tray & broad-spectrum on, screw, snap safe,
drying antibiotics desiccant capsules)
• Sieving / blending • Unit dose blister
13Our flexibility – your choice
AL AL
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.
14Our flexibility – your choice
AL AE
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.
15Our flexibility – your choice
AP
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.
16Granulation / Pellet manufacture
• 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
10 350 t available at
fluidized bed of pellets & granulate
granulators in CH produced in 2018 (CH) AL AP AE AUBulk Production
• 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
3 bn up to 900 k available at
bulk units capacity tablets / hr
in CH AL AP AE AU
18Flexible scale
• 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 m2 2 - 2’000 kg available at
floor space batch size
AL AP AE AU
19Primary 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
138 mio 5’250 km available at
blisters packed in of aluminium foil used in
2018 2018 AL AP AE AU
20Secondary Packaging
• 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 mio ~1’175 km available at
packs shipped in high tower of all packs
2018 shipped in 2018 AL AP AE AU
21Additional Services
• 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
2’303 300 available at
global registrations qualified suppliers in 2018
AL AP AE AU
22Liesberg & Aesch Quality Control Our brand new Quality Control laboratories meet and exceed the highest quality standards and requirements. We have know-how, technology and facilities to support you achieving your projects goals. Continuously investment in our equipment with the latest technologies constantly increases our capabilities. 1200 m2 ~50 QC area Employees in QC 29 6 HPLC Instruments UPLC Instruments 2’196 25, 30 & 45° C Samples analysed Stability chambers in 2018
Environment, health & safety
Environment, Health and Safety (EHS) is an integral part of
general management at Acino.
EHS System & Culture
The role of EHS is to provide the required tools to comply
with all regulations regarding occupational safety, hygiene
Occupational Medicine
Occupational Hygiene
Occupational Safety
Legal Compliance
Corporate Social
and medicine, environment, legal compliance and corporate
Responsibility
Environment
social responsibility.
EHS ensures the appropriate application of these tools for
safe workplaces and, at the same time, respect of the
environment. EHS supports Acino in taking all responsibilities
of an employer to protect employee`s integrity and
environmental resources for a sustainable future.
EHS Standard
- 35% OEL 1 - 3 EHS Politics
Less accidents within Level bulk manufacturing
one year (2018)
- 30% 4’192 h
Less rate of illness within Internal EHS training (2018)
one year (2018)
24100% 100%
clarity on contact commitment
persons
1 up to 4
dedicated CMO status calls per month
Account Manager
Your partner from wish to product
When 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 we
understand your means in full. Our team will then propose
the best options.
We know how situations can change within a minute, so we
commit to highest flexibility in our offerings, services and in
our every-day work to meet our customer’s demands &
expectationsProject Management that goes beyond
Our project management goes beyond the technical
realization of your project: By assuring fairness and
transparency in our project proposal, we keep an eye
on your budget and timelines.
The key to a successful project is a good planning – we
strive for close collaborations and open communication
with our customers directly from the start to make it
work right from the beginning.
With our long-term experience in manufacturing of oral
delivery forms, knowledge of your target markets &
regulatory excellence, we can advise our customers in
many aspects to make your project a success.
14 ~6–8m
transfer projects in duration of a packaging
2018 project
max. 1 ~ 12 – 18 m
month from RFQ to duration of a bulk project to
offer finalization of validationAcino Transfer Projects
9 - 15 months 3 - 12 months
Technical Preparation
Project Process Stability Document Continuous
Feasibility Process Registration
Preparation validation Studies ation Supply
Trials Validation
Documentation Small Scale Preparation Production of Packaging Validation Submission to
exchange Technical Trials Validation Plan Validation Batches of Stability Report relevant
Samples authorities
Transfer Plan Signature round
Testing of Analytics of Stability Report
Documents Stability Approval of
Preparation Analytical Validation Batches
Studies authorities
Material No. Methods Ordering/
according
Delivery of
Ordering/ Analytical ICH
API/Excipients
Delivery of Method Guidelines
API/Excipients Validation
Ordering of
ToolingSwiss time
>99% 1
OTIF target dedicated CMO Global
Supply Chain Manager
99% 370
batch release on GDP European road
time transports with partners
As a Swiss company, we make a commitment to the
deadlines and we agree with our clients on OTIF KPIs.
When we know, you know
In contract manufacturing there are times when we
face challenges and it’s times like this that you need a
reliable partner.
If deadlines are ever at risk we will inform you as soon
as we know and give you a clear overview of the
situation.Why work with us?
Open, transparent & pro-active communication
Technology & Stable Supply
Swiss Quality Flexibility
Know-How ChainOur Liesberg Team
Our Estonia Team
31Your contacts within Acino
Felix Faupel Yuliyana Manolova Patrick Frey
Head of Contract Business Development Global Key Account Manager
Manufacturing Contract Manufacturing Contract Manufacturing
felix.faupel@acino.swiss yuliyana.manolova@acino.swiss Patrick.frey@acino.swiss
linkedin.com/company/255145/ acino.swiss/contractmanufacturing/ facebook.com/acino.swissOur Quality
Our Technology
Our Flexibility
Thank you for YOUR BENEFIT
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