Recipharm is a contract development and manufacturing organization with 14 commercial manufacturing sites across Europe. It provides pharmaceutical development services from its facilities in Pessac, France and Solna, Sweden. Recipharm has extensive experience developing drug products for clinical trials and commercial markets. It offers a full range of development services from API development to clinical trials to technology transfer for commercial manufacturing. Recipharm aims to provide development services that facilitate efficient scale-up and technology transfer to its own commercial manufacturing sites or third party sites.
Group of companies PIQ-PHARMA suggests partnership in contract manufacturing of products for pharmaceutical companies having no their own production sites, or for companies interested in localization of foreign products in Russia. We can help with manufacturing of both solid and liquid dosage forms. We are ready to provide elaboration or adaptation of production technology in our own technological lab, and administer the registration of finished products in Russia.
Presentation given by Cipan at the BioEngineering Week (Semana da Bioengenharia – SBE) an initiative of the Bioengineering Department students of the Masters in Biological Engineering, Biomedical Engineering, Biotechnology and Microbiology of the Instituto Superior Técnico – Lisboa (http://sbe.tecnico.ulisboa.pt/).
Presentation given by Laurène Haurie from Plateforme Gala in the framework of the Emergence Forum Barcelona
Biocat organized the Barcelona Emergence Forum (April 10-11th, 2014, Congress Palace, Montjuïc) supported by the TRANSBIO SUDOE, a translational cooperation project dedicated to innovation in life sciences in South-West Europe. The Barcelona Emergence Forum contributed to bringing together Academics, Companies, Investment Entities, Technology Platforms and Technology Transfer Offices from Spain, France and Portugal to set up collaborative projects on Human Health & Agro-food Innovation.
More information at: http://www.b2match.eu/emergenceforum2014
Group of companies PIQ-PHARMA suggests partnership in contract manufacturing of products for pharmaceutical companies having no their own production sites, or for companies interested in localization of foreign products in Russia. We can help with manufacturing of both solid and liquid dosage forms. We are ready to provide elaboration or adaptation of production technology in our own technological lab, and administer the registration of finished products in Russia.
Presentation given by Cipan at the BioEngineering Week (Semana da Bioengenharia – SBE) an initiative of the Bioengineering Department students of the Masters in Biological Engineering, Biomedical Engineering, Biotechnology and Microbiology of the Instituto Superior Técnico – Lisboa (http://sbe.tecnico.ulisboa.pt/).
Presentation given by Laurène Haurie from Plateforme Gala in the framework of the Emergence Forum Barcelona
Biocat organized the Barcelona Emergence Forum (April 10-11th, 2014, Congress Palace, Montjuïc) supported by the TRANSBIO SUDOE, a translational cooperation project dedicated to innovation in life sciences in South-West Europe. The Barcelona Emergence Forum contributed to bringing together Academics, Companies, Investment Entities, Technology Platforms and Technology Transfer Offices from Spain, France and Portugal to set up collaborative projects on Human Health & Agro-food Innovation.
More information at: http://www.b2match.eu/emergenceforum2014
Process validation- This guidance incorporates principles and approaches that...Sanchit Dhankhar
This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing processes.
It is the process of establishing, through documented evidence, a high degree of assurance that a specific process will consistently produce a product that meets its predetermined specifications and quality characteristics.
Ko services brochure-online-hi-jan2021bSteve Brough
• Fragment Libraries
• Screening compounds
• Large collection of building blocks and intermediates
• PROTACs
• Custom and contract synthesis
• Scale up and route development
• Stable label synthesis
Concept to commercialization document gives an insight into the basic prerequisites of the technical & commercial process being followed at Stabicon. Its key input includes various segments of unmet needs in the Quality Management and address development, Analytical and services and innovation technology. Also a simplified business model along with our concept to completion laboratory design gives Stabicon additional efficiency & viability to our clients.
Excipients selection for high risk formulations Smita RajputMerck Life Sciences
Are you choosing the right excipients for your high risk application? Find out how to select the right excipients and enable your process optimization to improve the total cost of ownership.
In this webinar, you will learn:
• Selection of right excipients for high risk formulation is very critical step
• Low Endotoxin and low bioburden limits are important aspect while selecting raw materials
• Strong regulatory support is crucial for high risk formulation
Excipients selection for high risk formulations like parenteral and ophthalmic applications is very challenging. Excipients should be inert with high purity for such dosage forms because trace amounts of impurities present in excipients can interact with active pharmaceutical ingredient (API) which results in instability of the formulation. This presentation discusses how to select the right excipients for high-risk applications and gives guidance for process optimization by choosing the best combination of filters and excipients to improve the total cost of ownership.
Graphenstone Cradle To Cradle Gold Certified Calvin Degroodt
"Graphenstone presents materials whose raw material, lime, is obtained by artisanal means, helping to preserve the purity, density, the benefits and properties of limestone. The benefits of using the purest Lime: breathable, antibacterial, antifungal and insect repellent. It also contains graphene, a nano component manufactured through gas deposition, which enhances properties of flexibility, hardness, and thermal conductivity."
More information on our website, www.graphenstone.eu
Integrity Bio is a protein formulation development, fill finish, and drug delivery CMO. Injectable formulations include protein,antibody, vaccine, and peptide. http://www.integritybio.com
Developing a new Product that needs new environmentally friendly packaging or changing the packaging design
and need a laboratory for extractable or container closure testing. EFRAC, a highly admired ISO/IEC 17025:2017
accredited Laboratory extends packaging studies, research, testing, experimentation, developments, certifications
and studies.
We are highly equipped with different highly sophisticated, precise & robotic instruments for packaging material
testing & analysis.
Kemwell provides extensive mammalian cell culture-based formulation development services. The labs have the capability of performing complete process development, process optimization, scale-up, technology-transfers and process characterization.
This document gives detailed information regarding the processes followed in a Pharma Manufacturing Company.
It also includes graphical representation, for easy understanding.
Formulations in drug discovery, changing the formulation paradigm in early drug discovery, critical role of solubility and formulation screening, innovative formulation screening with low amounts of test compound and the impact of early formulation screening on pharmacokinetic studies from Suma Gopinathan at Lexicon Pharmaceuticals.
Process validation- This guidance incorporates principles and approaches that...Sanchit Dhankhar
This guidance incorporates principles and approaches that all manufacturers can use to validate manufacturing processes.
It is the process of establishing, through documented evidence, a high degree of assurance that a specific process will consistently produce a product that meets its predetermined specifications and quality characteristics.
Ko services brochure-online-hi-jan2021bSteve Brough
• Fragment Libraries
• Screening compounds
• Large collection of building blocks and intermediates
• PROTACs
• Custom and contract synthesis
• Scale up and route development
• Stable label synthesis
Concept to commercialization document gives an insight into the basic prerequisites of the technical & commercial process being followed at Stabicon. Its key input includes various segments of unmet needs in the Quality Management and address development, Analytical and services and innovation technology. Also a simplified business model along with our concept to completion laboratory design gives Stabicon additional efficiency & viability to our clients.
Excipients selection for high risk formulations Smita RajputMerck Life Sciences
Are you choosing the right excipients for your high risk application? Find out how to select the right excipients and enable your process optimization to improve the total cost of ownership.
In this webinar, you will learn:
• Selection of right excipients for high risk formulation is very critical step
• Low Endotoxin and low bioburden limits are important aspect while selecting raw materials
• Strong regulatory support is crucial for high risk formulation
Excipients selection for high risk formulations like parenteral and ophthalmic applications is very challenging. Excipients should be inert with high purity for such dosage forms because trace amounts of impurities present in excipients can interact with active pharmaceutical ingredient (API) which results in instability of the formulation. This presentation discusses how to select the right excipients for high-risk applications and gives guidance for process optimization by choosing the best combination of filters and excipients to improve the total cost of ownership.
Graphenstone Cradle To Cradle Gold Certified Calvin Degroodt
"Graphenstone presents materials whose raw material, lime, is obtained by artisanal means, helping to preserve the purity, density, the benefits and properties of limestone. The benefits of using the purest Lime: breathable, antibacterial, antifungal and insect repellent. It also contains graphene, a nano component manufactured through gas deposition, which enhances properties of flexibility, hardness, and thermal conductivity."
More information on our website, www.graphenstone.eu
Integrity Bio is a protein formulation development, fill finish, and drug delivery CMO. Injectable formulations include protein,antibody, vaccine, and peptide. http://www.integritybio.com
Developing a new Product that needs new environmentally friendly packaging or changing the packaging design
and need a laboratory for extractable or container closure testing. EFRAC, a highly admired ISO/IEC 17025:2017
accredited Laboratory extends packaging studies, research, testing, experimentation, developments, certifications
and studies.
We are highly equipped with different highly sophisticated, precise & robotic instruments for packaging material
testing & analysis.
Kemwell provides extensive mammalian cell culture-based formulation development services. The labs have the capability of performing complete process development, process optimization, scale-up, technology-transfers and process characterization.
This document gives detailed information regarding the processes followed in a Pharma Manufacturing Company.
It also includes graphical representation, for easy understanding.
Formulations in drug discovery, changing the formulation paradigm in early drug discovery, critical role of solubility and formulation screening, innovative formulation screening with low amounts of test compound and the impact of early formulation screening on pharmacokinetic studies from Suma Gopinathan at Lexicon Pharmaceuticals.
10 New Business Models for this Decade (beta)
1. Localized Low-Cost Business Model
2. One-Off Experience Business Model
3. Beyond Advertising Business Model
4. Markets Are Conversations Business Model
5. Low-Budget Innovation Business Model
6. Community-Funded Business Model
7. Sustainability-Focused Business Model
8. Twisted Freemium Business Model
9. Unlimited Niches Business Model
10. In-Crowd Customers Business Model
TREND RESEARCH BY Trend Firm trendwatching.com
MARKET ANALYSIS BY Strategy Boutique Thaesis
BUSINESS MODEL DESIGN BY Strategy Consultant/Graphic Facilitator Ouke Arts
Kuecept Ltd was founded in 2007 by a group of experienced industrial scientists to provide customised R&D solutions and consultancy services to the pharmaceutical, biotech and health-care industries.
Today, we are one of a few contract research organisations dedicated solely to providing preformulation, formulation development and enabling drug delivery services to companies in the discovery / preclinical stages. By working exclusively in this field, we have developed a wealth of knowledge and expertise of enabling drug delivery technologies and formulation know-how in drug solubility and bioavailability enhancement and with over 600 projects completed to date on over 250 NCEs, are well placed to help resolve some of the most complex drug development issues.
Our experience covers a broad range of discovery, development & related activities supporting oral, parenteral and orally / nasally inhaled drug products.
Aarti Pharmalabs Ltd specializes in the clinical phase and commercial production of APIs and NCEs, intermediates, regulatory starting materials, key building blocks and xanthine derivatives. Our offerings include process R&D, analytical method development and validations, stability studies, scale-up and process optimization, process validations and commercial production. The quality and purity of our products have enabled us to be the leading Active Pharmaceutical ingredients manufacturers in India.
Spread over more than 1,05,000 sq. ft. area, Cadila Pharmaceuticals’ R & D facilities, recognized by the Department of Science & Technology, Government of India, are manned by more than 300 scientists. A centralized Quality Control & Analytical Research Laboratory has been set up to meet the domestic and international quality standards. The Company has expanded operations by building further on already existing set-up by investing in new premises, to include modern, state-of-the-art amenities. One of the few companies in the country carrying out collaborative research, Cadila Pharmaceuticals taps the best scientific talent in the country and has collaborations with more than 30 leading Research and Development centers in India.
To know more about Cadila Pharmaceuticals visit: http://cadilapharma.com/
Stabicon has been ambitiously established in 2010. Professionally managed with 75 scientists from diverse background expertise. Our organization is specialized in managing product quality process, upgrading and introducing advanced technology into products. we are proud to lay a foundation for prosperous future in prevention and cure segment, future medicine & FMCG business.
LGM Pharma | Drug Research & Development APIsLGM Pharma
LGM Pharma is a leading innovative U.S. supplier and distributor of active pharmaceutical ingredients (APIs) to pharmaceutical, manufacturing, biotech, and pharma R&D markets.
2. RECIPHARM GROUP KEY FACTS
• Contract development and manufacture
‒ API and drug product
• Established in 1995
• Since 2007 primarily a CDMO
• 2014 Revenue SEK 3.3 bn (approx. €340m)
• About 2200 employees
• Traded at the NASDAQ OMX Stockholm since April 2014
• >400 products in >100 markets
• 2 development facilities in Sweden and France
• 14 commercial manufacturing facilities:
‒ Sweden (4), France (2), UK (1), Germany (1), Portugal (2) Italy
(3)and Spain (1)
2
3. SITES ACROSS EUROPE
322 June 2016
Italy
LAINATE (Milano)
● Lyophilised sterile beta lactam antibiotics
MASATE (Milano)
● Lyophilisates
● Liquid fills
PADERNO DUGNANO (Milano)
● API development
● API manufacturing
Portugal
QUELUZ (Lisbon)
● Solids
● Liquids
● Semi-solid
● Some development
ODIVELAS (Lisbon)
● Solids
● Liquids
● Semi-solids
● Steriles
● Some development
Sweden
JORDBRO, HQ
HÖGANÄS
● Solids (granulates &
powders)
KARLSKOGA
● Semi-solids
SOLNA
● Development
Services
STOCKHOLM
● Solids
STRÄNGNÄS
● Beta lactams
(solid forms and
dry syrups)
UK
ASHTON
● Solids
● Semi-solids
● Inhalors
Germany
WASSERBURG
● Lyophilisates
● Steriles
France
FONTAINE
● Solids
MONTS
● Steriles
PESSAC
● Development
Services
Spain
PARETS
● Solids
● Semi-solids
● Liquids
4. RECIPHARM AB
4
CEO
Thomas Eldered
Manufacturing
Services, COO and
Executive VP
*Kjell Johansson
Operations
Development,
VP
*Magnus Renck
Business Management,
VP
*Kenth Berg
Development &
Technology,
Executive VP
*Carl-Johan Spak
Corporate
Development,
Executive VP
*Mark Quick
Human Resources,
VP
*Jonas Lejontand
Executive Assistant
Gunilla Rydquist
Legal, Company
Lawyer
Erik Domines
Financial, Control &
Investor Relations,
CFO & Executive VP
*Björn Westberg
* Group Management Team
5. DEVELOPMENT & TECHNOLOGY
Development &
Technology
Carl-Johan Spak
Recipharm
Pessac SA
Stéphane Guisado
Recipharm
Pharmaceutical
Development AB
Maria Lundberg
Recipharm
Pharmaceutical
Products AB
Johan Åkerblom
Recipharm
Venture Fund
Carl-Johan Spak
Sales
Torkel Gren
5
6. RECIPHARM PHARMACEUTICAL DEVELOPMENT
SERVICES
• Development unit within Recipharm group since 1995
• Two dedicated development sites
‒ Pessac, France, ~110 employees
‒ Solna, Sweden, ~45 employees
‒ Special development at some commercial sites
• Relatively small sites focused on development
‒ flexibility & speed
• Collaboration with 14 commercial manufacturing sites
• Extensive experience of development of drug products for
clinical trials and market
Large enough to deliver
Small enough to be fast and flexible
7. PHARMACEUTICAL DEVELOPMENT SERVICES
7
API development
Raw and packaging material
selection and sourcing
Formulation development
and drug delivery
Analytical method
development and validation
Clinical supply
Phase I and BE clinical trials
(through partner)
Stability studies
Regulatory services
22 June 2016
Project management Scale up and technology
transfer
8. SEAMLESS COORDINATED DEVELOPMENT SERVICES
• Recipharm offers a complete package of drug development services from
molecule to product
• API development (Milan)
• Drug Product development (Pessac and Solna)
• Phase I and BE clinical trials (through partner, CTC Uppsala, Sweden)
• Tech transfer to commercial manufacture
• RECIPHARM – THE PHARMACEUTICAL DEVELOPMENT ONE STOP SHOP
‒ With the option to buy just one piece
8
API
Drug
Product
Clinical Trial
Commercial
Manufacture
11. API DEVELOPMENT CAPABILITIES
• GMP manufacture of Active Pharmaceutical Ingredients
• Development of chemical processes and analytical methods up to
registration on a global basis (EU, US, Japan, etc…)
• Most types of substances can be manufactured
‒ No cytostatics hormones and betalactam antibiotics
• Our plant can produce batch size from 1 g to 400 kg
• GMP kilo lab dedicated to small volume API (1 gr/ 1 kg)
• GMP Pilot (up to 5-10 kg)
• Commercial manufacturing available (up to 400kg)
• Technical transfer capabilities
• Approved for human and veterinary applications
• APIs support for all clinical phases
• Site in Paderno Dugnano, close to Milan , Italy.
13. ALL COMMON DOSAGE FORMS
Dosage form
Phase 1 Phase 2 Phase 3 Commercial
Tablets and
powder1
Yes Yes Yes Yes
Capsules2 Yes Yes Yes Yes
Coated beads Yes Yes Yes Yes
Semisolids Yes Yes Yes Yes
Oral liquids Yes Yes Yes Yes
Steriles Yes Yes Yes Yes
1Immediate-release tablets, coated tablets, enteric-coated tablets, sustained release tablets,
tablets with active substance(s) in different layers
2Coated or non-coated
13
14. Special formulations
• Coated pellets
‒ for extended or delayed release
• Effervescent tablets
• Ophthalmic products
• Minitablets
• Metal coordinated
pharmaceuticals
• Parenteral polymers
14
Drug substances with special
requirements
• Controlled substances
• Beta-lactam antibiotics
‒ In collaboration with
manufacturing site
• Hormones
‒ In collaboration with
manufacturing site
SPECIAL CAPABILITIES
15. STATE OF THE ART PELLET DEVELOPMENT AND
MANUFACTURE
16
• 1000 + 700 m2 with excellent equipment
• Batch size: 400 g – 150 kg
• Water or organic solvents
• Long experience in developing products for
clinical trials and the market
From US Patent 6,770,295
16. EFFERVESCENT TABLETS
• Offers a practical solution for high dose drugs that are
difficult to swallow
• Suitable especially for OTC products
• Developed and manufactured in Lisbon, Portugal
17
17. OPHTHALMIC PRODUCTS
• Product for administration to the eye is an important niche
market
‒ The global ophthalmic therapeutic market > $15 billion
‒ Glaucoma is the most important indication
• Sterility often in combination with viscous products may be
challenging
• Existing projects
‒ Development in Solna, manufacturing Karlskoga
‒ Developed and manufactured in Lisbon Portugal
18
18. MINITABLETS
• 3 mm or less
• Individualized dosing
‒ Optimal effect
‒ Less side effects
• Easy to swallow
• Convenient to use
• Can be combined with dosing device
19
19. METAL COORDINATED PHARMACEUTICALS
• Patentable entity created by
coordinating metal to known active
molecules
• Improved pharmacokinetic
properties through choice of metals
and adjuvants
• Different metals and ligands offer
great flexibility
• Potentially expedited regulatory
review
20
CH3
S
CH3
O
CH3
S
CH3
O
R
O
O
R
O
N
H2
O
Mg
N
H2
Ligand
20. METAL CORDINATION CAN IMPROVE DIFFERENT
CHARACTERISTICS OF AN ACTIVE MOLECULE
• Improved water solubility
• Improved lipid solubility
• Improved and less variable bioavailability
• Controlled Release
• Targeted delivery
• Accelerated onset of action
• Increased bioadhesion
• Compatible with current formulation, delivery and targeting
technologies
21
21. METAL COORDINATION IS A POWERFUL TOOL IN
PRODUCT DEVELOPMENT
• Improve the characteristics of new active molecules
‒ Better products
‒ Can be the difference between success and failure for a new
molecule with poor PK characteristics
‒ Improved patent protection
• Develop new products from known molecules
‒ Distinct therapeutic advantages
‒ Lower costs and less risk than developing new molecules
‒ Exclusivity through efficient patent protection
• Synthonics and Recipharm will collaborate in applying metal
coordination in the development of your product!
22
22. POLYMERS FOR PARENTERAL APPLICATIONS
• New polymers offer opportunities in parenteral and local
drug delivery
‒ E.g. depot effect
• Pyrogen-free low bioburden polymers for sterile
applications are being provided
23
23. RECIPHARM SOLNA
• Located in Solna (Stockholm area) Sweden
• Fully compliant GMP Pharmaceutical Development Facilities
‒ EU approved
• Dedicated development facility in two floors (3,000 m2)
‒ GMP classified area: 500 m2
‒ Class B + Class C: 150 m2
• Flexible facility
• Development of most type of dosage forms
• Analytical development, QC lab, stability studies
24
24. RECIPHARM PESSAC
• Located in Pessac (Bordeaux area, France)
• Fully compliant GMP Pharmaceutical Development and
Manufacturing Facilities
‒ FDA approved
‒ EU approved
• 45,000m² site with 9,700m² of production and development
space:
• State of art spray-coating equipment
• Analytical and microbiological laboratory
• QC lab and stability studies
25
26. RECIPHARM COLLABORATION WITH CTC FOR EFFICIENT
PHASE I TRIALS
• Through our collaboration with CTC Clinical Trial Consultants
AB we can offer benefits to customers
‒ simpler
‒ faster
‒ less costly
‒ more information can retrieved by adaptive design
• Benefits of carefully coordinating the work
‒ manufacture clinical trial material
‒ planning, performing and evaluating the clinical trial
‒ easy and smooth
‒ we take full responsibility for the coordination of all the work needed
27
29. DEVELOPMENT WITH COMMERCIAL MANUFACTURE IN
MIND
• Access to excellent experts in large scale manufacture during
the entire development
• Methods are developed in order to work well on large scale
equipment
• Efficient Tech Transfer
‒ Seamless tech transfer to our own manufacturing sites
‒ Our expertise allows smooth tech transfer to third parties
30
30. PROJECT MODEL
• An experienced project manager follows the project from
quotation to delivery
‒ Overall responsible for meeting project goal
‒ The project manager is the main contact point for customer
• Effective communication
‒ Frequent status update meetings - frequency and meeting
forms are adapted to customer needs
‒ Customer is informed promptly if there are changes
• Project plan
‒ Agreed with customer, usually at face-to-face meeting
‒ Management meets weekly to track progress and solve any
resource issues in the projects
31
31. SUMMARY
32
A complete set of development services
From idea to commercial product
We are LARGE enough to deliver
SMALL enough to be fast and flexible
Large : financial stability, finance, resources
Small : flexibilty, independant companies
“Pharmaceutical development services offers a wide range of services for development of almost all dosage forms. There is also a fee for service based revenue model.”
Regulatory services with CMC parts, can help to compile dossier
Topical aerosols : made at Parets and only large volumes are available today
Coated beads : limitation 100 to 150 kg batch size
Investments : tablettling investment
Preparation to prepare small scall fill in from RPS
Beta lactam avec Stragnas
Hormones with Ashton (levotyroxine project in progress)
Pellets vs 2 tablets per year
Reduction of side effects
Improvment of effect
Création d’un centre d’excellence
- developped for sensidose with dose automate
Approved since 2014
Parkinson applicable, last stages
Pas encore testé chez les humains actuellement
Private company located at Hospital combination with Recipharm
Rapide, pas besoin de bcp de stabilité
Gestion groupée par RPD, simplifier la vie et accélérer la réalisation des études
Many projects of tech transfer from devlopment to other sites
We can do Tech transfer to customer site or 2 others CMO