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/).

1. Semana BioEngenharia – IST
Manuel Eduardo Fernandes
|Plant Manager – Director Fabril | Cipan S.A.
29-02-2016

2. A PORTUGAL-BASED SPECIALTY PHARMACEUTICAL COMPANY DEDICATED TO THE
RESEARCH, DEVELOPMENT AND MANUFACTURE OF
ACTIVE PHARMACEUTICAL INGREDIENTS AND ADVANCED INTERMEDIATES
SPECIALIZING IN ANTI-INFECTIVES THROUGH FERMENTATION AND CHEMICAL SYNTHESIS

3. Cipan researches, develops and produces a wide range of Active Pharmaceutical Ingredients for the
global pharmaceutical market
 Installed fermentation capacity in excess of 210,000
gallons or 850,000 liters
 Large scale API organic semi-synthesis units
 Total reactor capacity over 160,000 gallons or 640,000 liters
 High capacity for HYDROGENATION reactions
 PAT technology applied to process optimization.
CIPAN started its operations in 1963 and exports API’s to the US since 1965 after being successfully
inspected by the FDA for the first time

4. Over 50 years of API fermentation and organic synthesis expertise
Fast prototyping of industrial processes through advanced pilot plant facilities
Process Analytical Technology (PAT) expertise
FDA and Infarmed sucessfully inspected facilities since 1965
Intensive knowledge of the worldwide API market
Effective technology transfer for Turnkey projects
Partnership and Contract Manufacturing business models
Integration with US-based Finished Dosage Form manufacturers
Cipan’s competitive edge

5. • Minocycline hydrochloride;
• Lymecycline;
• Tetracycline Base and Hydrochloride;
• Sancycline Base and Hydrochloride;
• Calcium Oxytetracycline.
CIPAN’s APIs/Intermediates Portfolio includes:

7. We aim to:
• Be an expert and a one-stop-shop for Tetracyclines
• Be a partner of choice to companies that are developing novel Tetracyclines
• Be a partner of choice serving innovative companies in the development, scale-up, industrialization and
manufacturing of its products; in particular products which require expertise in fermentation, purification and
chemical synthesis;
• Cipan is looking into products that are difficult to manufacture and targeting developed/regulated markets
were our prospect clients value quality, reliability and assurance of supply more than solely the price at which
the product is marketed;

8. Working as a CDMO in the Development of novel Tetracyclines to address unmet medical needs
 Our client is doing the following:
 Oral/IV antibiotic addressing bacterial resistance
 Enrolling two pivotal trials –ABSSSI and CABP
 Developing for UTI
 Potential additional indications -Sinusitis

9. Cipan´s scope of work: Tech transfer and Validation
Stage I
- Process Assessment
and Implementation
Stage II
- Engineering run
Stage III
- Registration runs
Process Validation

10. Three years contract Manufacturing collaboration with a European Company for the scale-up and
production of several crucial oligosaccharides for Human Health using state-of-the-art technologies like:
Fed-batch fermentations using different GMO
strains (2Lt – 1m3)
Membrane technologies (UF, NF, ED, etc.)
Purification steps
Crystallization
Filtration & Drying

11. In the scope of this collaboration we can highlight:
• a 50% increase in the titre of fermentation compared
with the first technology received;
We can also claim to be the
first company in the world to
produce this type of
oligosaccharides at the 100
kg’s scale through biologic
processes
• The development and implementation of a more
economic and less time consuming crystallization
process

12. To be competitive three things must be acomplished almost at the same time:
1. Conceive and develop new processes from scratch;
2. Test and optimize them at k-Lab and pilot scale;
3. Build or revamp new or existing facilities adding or modifying equipment
All at the same time

13. Development and optimization must go hand-in-hand so that time-to-market can be reduced and
the cost constraints faced by the pharmaceutical industry can be properly addressed

14. This is where the expertise and body of knowledge of chemical and biologic engineers becomes
a critical success factor;
1. Through process and predictive modeling;
2. Leading to process understanding, improving the speed of development;
3. Developing new technology platforms and leaner manufacturing methods

15. A HUGE OPPORTUNITY FOR BIOLOGIC AND CHEMICAL ENGINEERS!
Thank you!
Manuel Eduardo Fernandes
|Plant Manager – Director Fabril | Cipan S.A.
29-02-2016