OLON continues strategic collaboration with Novartis, supporting the expansion of the Africa Sickle Cell Disease program to Kenya, Uganda and Tanzania

OLON continues strategic collaboration with Novartis, supporting the expansion of the Africa Sickle Cell Disease program to Kenya, Uganda and Tanzania

OLON announced it will continue its collaboration with Novartis to support the Africa Sickle Cell Disease program as it expands to Kenya, Uganda and Tanzania.  Initially launched in 2019 by Novartis and its partners in Ghana, the Africa Sickle Cell Disease program intends to improve the lives of people with sickle cell disease and accelerate access to treatment and related laboratory tests.

Sickle Cell Disease is a congenital blood disease that affects red blood cells that change in shape, causing the loss of structural and functional integrity, to the point of compromising their ability to transport oxygen. It is associated with high mortality and morbidity rates and is prevalent in countries with a high prevalence of malaria. It is estimated that about 80% of cases occur in Sub-Saharan Africa1, with 200,000 children born with the disease every year4, of which up to 90% die within the first 5 years of life.5

OLON plans to donate the active ingredient to cover approximately 12,000 treatments of hydroxyurea, the current standard of care for the treatment of sickle cell disease. In 1992, hydroxyurea was recognized as the first drug approved for the causative treatment of Sickle Cell Disease, demonstrating a reduction in the number and severity of attacks2 and an extension of survival3

“I am proud that OLON will continue being a partner of Novartis this year and further contribute to pursuing the ambitious goals of the Sickle Cell Disease program,” said Paolo Tubertini, CEO of OLON. “When we began our collaboration in 2019, it was a source of pride and honor for the entire OLON Company and a demonstration of what is important to us. Our ambition in supporting Novartis and this project is to act as a non-profit business, and we are, more than ever, committed to help expand the accessibility and affordability of these medicines to those that need them most, starting in Africa.”

Thanks to the support of its partners, including OLON, Novartis has already delivered more than 6 million capsules of hydroxyurea to Ghana to date and more than 2000 patients have already received treatment.

“In this time of worldwide uncertainty, it is even more important to support people living with chronic conditions like sickle cell disease,” said Dr. Patrice Matchaba, Group Head of Global Health & Corporate Responsibility at Novartis.  “We are pleased to have partners like OLON join us on this journey to reimagine treatment and care for people with sickle cell disease.”

The Novartis Africa Sickle Cell Disease program consists of public-private partnerships where Novartis and its local partners have agreed to explore collaboration opportunities aimed at tackling the growing burden of SCD in their countries. The partners intend to develop and implement a comprehensive approach that includes making diagnosis and treatment available, accessible and affordable for patients and their families; promoting scientific research, training and education; and pursuing robust monitoring and evaluation of the program.

Capua OLON Biotech impegnata nella progettazione di un sistema innovato Multipurpose R&D per enzimi a scopo terapeutico

Capua BioServices Spa (OLON Biotech), parte del gruppo OLON SpA, grazie al supporto derivante dal programma di finanziamento europeo Horizon 2020 – PON 2014/2020, sta conducendo con successo il progetto di ricerca industriale e sviluppo sperimentale dal titolo: “Studio e progettazione di un sistema innovato Multipurpose di R&D per enzimi a scopo terapeutico, con focus particolare su enzimi destinati alla cura di malattie rare e intermedi di base sviluppati mediante processi biotecnologici”.
Capua BioServices (OLON Biotech) vuole inserirsi, attraverso questo progetto innovativo, come partner in grado di offrire innovazioni tecnologiche ed intellettuali, che permettono di accelerare i tempi, di ridurre sensibilmente i costi legati alla realizzazione di impianti necessari a rendere disponibile un prodotto biotech sul mercato.

SMEPAC certification received for an area of OLON F1 production plant

We are pleased to communicate that an area of OLON F1 production plant, at Rodano site, has received the SMEPAC certification.

The plant includes lines 3 and 4 for the production of High Potent Active Ingredients (HAPI) with high containment, recognized OEB4 and OEB5, thanks to the use of specific technologies such as filter driers, isolators for powder loading and unloading (glove-boxes) and high-tech confined areas.

The plant allows to handle substances in isolation according to a scale that varies from OEB1 to OEB5, where OEB5 represents the maximum containment value and that is why, the high performance attributed to our plant, is for us a big potential for the production lines.

The emphasis that this type of plant has received in the last few years is mainly due to the desire to minimize the impact of the manipulation and synthesis of chemicals on the external environment.

For this reason, the production and handling processes of the High Potent Active Ingredients must be carried out safely in equipment that keeps all the material being processed inside it, creating a protective barrier between the operator/external environment and inside the equipment.

OLON invests on solvents materials recovery plant at Rodano site

At the end of 2018, Olon signed an important investment to build a plant for the recovery of solvents materials from chemical productions.

In just over one year, the ambitious project was completed, including: a distillation plant with double batch columns, which allows the recovery of solvents of processes production; 6 storage tanks of distillate solvents and 4 for raw material storage; a control room for programming and monitoring; a laboratory for quality control.

The entire structure has multipurpose capabilities and in a short time the plant will be extended for other processes to recover solvents materials from all Olon sites, which would otherwise be disposed of and lost.

OLON API’s Nitrosamine confirmatory test

The analyses of nitrosamines are challenging. Ultralow levels of these impurities must be quantified in diverse and complex matrices. The developed methods then need to be validated to conform to GMP requirements.

OLON is internally equipped with the required equipment to meet these limits, including Thermo Scientific™ Q Exactive™ Hybrid Quadrupole-Orbitrap Mass Spectrometer.

We have experience with nitrosamine testing, including validating quantitative and test limit methods for our APIs, as well as screening testing methods.

We can provide both toxicological and analytical support for risk evaluation using also third parties qualified suppliers.

OLON announces the opening of 2 new areas at Segrate site

OLON announces the opening of 2 new areas at Segrate site that will help us increasing our production and or know-how:

– a new process safety laboratory able with state of the art equipment such as reaction calorimeter, adiabatic calorimeter and DSC

– a new containment pilot plant: this new investment further strengthens and expands the range of services OLON now can offer to our customers by extending them to a higher level of containment and processing of highly active ingredients

We support those who support us

OLON is a privileged company that, like others, has the benefit and the commitment of continuing industrial activities to produce medicines.

This makes us think about our role: we represent a value for the community and not only for ourselves.

Aware of this, we opened a specific aid program towards all Italian municipalities in which we operate as they are the first structures facing the difficulties of citizens and will proceed on this way.

Some examples of the initiatives we support are: the distribution of masks to citizens in the Municipality of Casaletto Lodigiano; the activation of the psychological listening service in the Municipality of Dorno; the purchase of material for the Red Cross of the Municipality of Capua; free meals for people in difficulty in the Municipality of Mulazzano … and many others.

If we can contribute to our communities it is also thanks to the dedication and resilience that all our employees are showing; for this, we wish to extend the thanks received from the Mayors to all of them.

We are OLON #allinone #dontstopOLON

Olon S.p.A. expands microbial GMP capabilities at its manufacturing site in Capua

Olon S.p.A., a world leading Active Pharmaceutical Ingredients (API) contract development and manufacturing organization (CDMO) and generics supplier, celebrates today the start of the construction of a new GMP manufacturing facility at its microbial CDMO facility located in Capua, Italy.

Paolo Tubertini, CEO of Olon, commented, “I am pleased to announce the start of this GMP capacity expansion just within 6 months after the acquisition of Capua BioServices. This truly confirms the real opportunity to accelerate growth in Olon‚ CDMO service positioning and to be recognized as European Leader in the CDMO of microbial fermentation.”

The construction of this new GMP facility is associated to a long-term strategic partnership with a large pharmaceutical company. The engineering project is designed to support the manufacture of multiple products, up to commercial scale. It is a great addition to Olon‚ recent successes in the development and execution of GMP as well as Food-grade engineering projects; from first concept to final commissioning, based on green-field and brown-field, under extremely challenged timelines.

About Olon

Olon is an Italian company providing global services in the field of API manufacturing (including generics) and CDMO services; based on chemistry and biotechnology. Olon offers dedicated solutions for its clients in pharmaceutical and food industry; from R&D to pilot to commercial stage.

In 2018 the company reached a turnover of US$ 500 million with approximately 2000 employees. Headquartered in Rodano (Milan, Italy), Olon has 11 manufacturing facilities spread over Europe (Italy and Spain), USA (Concord OH) and India (Mahad) as well as branch offices in Hamburg (Germany), Florham Park NJ (USA) and Shanghai (China).  Olon combines its unique manufacturing capacity in chemistry (7320 m3) and fermentation (4500 m3), with its track record in API’s (>100 years of experience, >230 API’s) and CDMO (>50 years of experience, >30 projects per year) and with its core capabilities such as fluorination, carbonylation and high-potent manufacturing (>30 HPAPI).

Olon acquires CapuaBioservices S.p.A.

March 18-21, 2019 – NY USA – Meet OLON team at DCAT week

Olon S.p.A., a world leading Active Pharmaceutical Ingredients (API) contract development and manufacturing organization (CDMO) and generics supplier, announced today the acquisition of Capua BioServices S.p.A., a global provider of CDMO services in the field of microbial fermentation, as part of a continuing expansion of its global footprint.

Paolo Tubertini, CEO of Olon, commented, “By acquiring Capua BioServices, Olon will have the opportunity to accelerate growth by adding new CDMO projects and to be recognized as European Leader in the CDMO of microbial fermentation (total fermentation capacity of 4.500 m3). It comes with a world-class manufacturing facility and a dedicated team of experts that will support us in delivering high-quality services that meet or exceed customer expectations.

Following the acquisition of Ricerca Biosciences’ Chemical Division in mid-2017 and the manufacturing site in Mahad (India), announced in Q3 2018 with closing in Q1 2019, we have now completed a further step in our strategic plan. With this acquisition Olon has successfully finalized his 3 years’ development plan.”

Capua BioServices is a global provider of high-quality services in the field of custom microbial process development and manufacturing. Capua BioServices offers dedicated solutions for proteins, specialty small molecules and microorganisms for applications in pharma, food, feed and other bio-industrial markets. The site is beta-lactam free with a total fermentation capacity of about 1.400 m3, located in Capua, nearby Naples (South of Italy) with approximately 200 employees. Over the past 60 years, the company has built a track record based on extensive experience in working with a variety of bacterial, yeast and fungal systems. No impact on jobs is planned and Olon intends to invest in the site and pursue business development opportunities to optimize the plant’s utilization and expand its customer base.

About Olon

OLON is an Italian company leader in the production of Active Pharmaceutical Ingredients (APIs) via synthesis and biological processes for the generic market and for contract development and manufacturing (CDMO) requirements.

Complementary to our activities is the Dossier Unit, whose team of dedicated professionals work on the development of the Finished Drug Formulations (FDFs) and the preparation of the Common Technical Documents (CTD) dossier.

Turnover in 2018 of US$ 400 million, with more than 250 APIs (31 under CMO) for the Generic market and 33 chemical intermediates (under CMO).

Olon is holder of about 130 active US DMFs and 50 granted CoS. and is able to handle several particular process technologies, such as Fluorination, Carbonylation and Fermentation.

With 1,500 employees, of which 200 alone are in the specialized R&D team, Olon offers complete integrated packages and services to support full development of APIs based on strong knowledge in both Chemical and Biological process, all in full cGMPs and with regulatory coverage.

Headquartered in Rodano (Milan, Italy), Olon has 10 manufacturing facilities ‚Äì 7 located in Northern Italy, 1 in Spain 1 in USA and 1 in India, all compliant with international requirements, and 3 branch offices in Hamburg (Germany), Florham Park NJ (USA) and Shanghai (China). 
The manufacturing sites are regularly inspected by the most important national and international Authorities, and regularly audited by our partners and customers. The facilities are FDA-inspected and self-identified under GDUFA.

In addition to pharmaceutical certifications, Olon has dedicated areas for food-grade manufacturing and complies with Kosher, Halal and from 2018-Q2 with FSSC 22.000.

For further information please contact:

Mrs. Elena Barboni / Olon S.p.A.
Tel.: +39 02 9523 5208 – Email: ebarboni@olonspa.it

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