Semana BioEngenharia – IST

Manuel Eduardo Fernandes|Plant Manager – Director Fabril | Cipan S.A.

29-02-2016

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

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

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

• Minocycline hydrochloride;• Lymecycline;• Tetracycline Base and Hydrochloride;• Sancycline Base and Hydrochloride;• Calcium Oxytetracycline.

CIPAN’s APIs/Intermediates Portfolio includes:

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;

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

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

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

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

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

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

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

A HUGE OPPORTUNITY FOR BIOLOGIC AND CHEMICAL ENGINEERS!

Thank you!

Manuel Eduardo Fernandes|Plant Manager – Director Fabril | Cipan S.A.

29-02-2016