Acino Contract Manufacturing Overview Introduction to Acino Contract - - PowerPoint PPT Presentation

Acino Contract Manufacturing Overview Introduction to Acino Contract Manufacturing Services July 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-Licensing

Acino products sold in European and other markets by a broad range of leading pharmaceutical companies

 Contract Manufacturing

Customers’ products are manufactured and packaged by Acino, often with a full-service business model

311 m€

Sales in 2018

~1’950

Employees globally

>75%

Sales in Emerging Markets 400 Employees in Switzerland

75% : 25%

Sales split B2C : B2B

3

Manufacturing sites (CH, EE, UA)

183 Years

Of Swiss company history

100%

Privately owned by Avista Capital & Nordic Capital

Where we deliver our products to

3

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

Technology we’re proud of

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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

Years experience in pharm. manuf.

>60

Countries being supplied with our products

10

multi-national pharma customers

27

small-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

224

Quality 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 Manufacturing Packaging Manufacturing Packaging Packaging, Logistics, Warehouse

AL AD AE AU

Aesch, Pfeffingerring, Switzerland Packaging, Logistics, Warehouse

AP

CH EE UA

7

Zurich, Switzerland Headquarters

HQ

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

Employees

~55

Employees in production

3’400 m2

Production area

10’500 m2

Total site area

33 km

Distance to Basel

3 bn

Bulk 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 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

Employees

42%

Employees with higher education

1’176 m2

Packaging site area

5’100 m2

Total site area with technical area and warehouse

228 km

Distance Tallinn to Polva

15 mio

Packs 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 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

Employees

1 bn

Tablet capacity

1 bn

Capsule capacity

2’150m²

Total production site area

June 2019

EU GMP Audit planned

30 mio

Packs capacity

Acino CMO Offering - Overview

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Granulation/Pelletization

• Wet (aqueous &
• rganic), 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-

• n, screw, snap safe,

desiccant capsules)

• Unit dose blister

Secondary Packaging

• Standard secondary

packaging (for packs &

• bottles)
• PIL-packages
• Artwork management
• Serialization &

aggregation

• Warehousing &

logistics

14

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.

15

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.

16

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

10

fluidized bed granulators in CH

350 t

• f pellets & granulate

produced in 2018 (CH)

Granulation / Pellet manufacture

available at

AL AU AP AE

18

• 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 bn

bulk units capacity in CH

up to 900 k

tablets / 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 m2

floor space

2 - 2’000 kg

batch size

available at

AL AU AP

Flexible scale

AE

20

138 mio

blisters packed in 2018

5’250 km

• f aluminium foil used in

2018

available at

AL AE AU AP

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 mio

packs shipped in 2018

~1’175 km

high tower of all packs shipped in 2018

available at

AL AE AU AP

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

2’303

global registrations

300

qualified suppliers in 2018

available at

AL AE AU AP

Additional Services

Liesberg & 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

• ur capabilities.

1200 m2

QC area

~50

Employees in QC

29

HPLC Instruments

6

UPLC Instruments

2’196

Samples analysed in 2018

25, 30 & 45° C

Stability chambers

Environment, health & safety

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Environment, Health and Safety (EHS) is an integral part of general management at Acino. The role of EHS is to provide the required tools to comply with all regulations regarding occupational safety, hygiene and medicine, environment, legal compliance and corporate 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
• f

an employer to protect employee`s integrity and environmental resources for a sustainable future.

• 35%

Less accidents within

• ne year (2018)

OEL 1 - 3

Level bulk manufacturing

• 30%

Less rate of illness within

• ne year (2018)

4’192 h

Internal EHS training (2018)

EHS Politics EHS Standard

Occupational Safety Occupational Hygiene Occupational Medicine Environment Legal Compliance Corporate Social Responsibility

EHS System & Culture

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

• ur every-day work to meet our customer’s demands &

expectations

100%

clarity on contact persons

100%

commitment

1

dedicated CMO Account Manager

up to 4

status calls per month

Project Management that goes beyond

14

transfer projects in 2018

~ 6 – 8 m

duration of a packaging project

• max. 1

month from RFQ to

• ffer

~ 12 – 18 m

duration of a bulk project to finalization of validation

Our project management goes beyond the technical realization of your project: By assuring fairness and transparency in our project proposal, we keep an eye

• n 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.

Acino Transfer Projects

Project Preparation Technical Feasibility Trials Preparation Process Validation Process validation Stability Studies Document ation 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

• f 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

1

dedicated CMO Global Supply Chain Manager

99%

batch release on time

370

GDP European road transports with partners

As a Swiss company, we make a commitment to the deadlines and we agree with our clients on OTIF KPIs. 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.

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 Manolova

Business Development Contract Manufacturing yuliyana.manolova@acino.swiss

linkedin.com/company/255145/ acino.swiss/contractmanufacturing/ facebook.com/acino.swiss

Felix Faupel

Head of Contract Manufacturing felix.faupel@acino.swiss

Patrick Frey

Global Key Account Manager Contract Manufacturing Patrick.frey@acino.swiss

Our Qua lity Our T e c hno lo g y Our F le xib ility

YOUR BE NE F IT YOUR CHOICE

Thank you for your attention!