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Highly Active Pharmaceutical Manufacturing

Sanofi has experience with industrial development of all kinds of projects and brings new chemical entities to market.

The industrial organisation within Sanofi, Industrial Affairs, includes a business unit dedicated to third-party activity Commercial and External Partnership, Industrial Affairs (CEPiA).

One of CEPiA’s missions as a contract manufacturing organisation within Sanofi is to provide manufacturing solutions for active pharmaceuticals ingredients (API) to external customers. A key activity is the manufacturing of highly active pharmaceutical ingredients (HAP) and cytotoxic compounds. This activity stems from Sanofi’s expertise gained through the manufacturing of taxanes (Docetaxel, Taxotere® and Cabazitaxel, Jevtana®) and in the development of other drugs for oncology.

CEPiA is glad to present to customers its dedicated equipment and facilities for highly active products manufacturing. Customer HAP projects will be managed by the same experts who have developed and launched Taxotere® and Jevtana®.

The company’s high-level of expertise has been acquired handling cytotoxic compounds for more than twenty years and is based on five major principles:

  • Extensive knowledge in chemistry
  • State of the art facilities
  • Highly trained personnel
  • Environment, health and safety experts
  • High standards in quality

This extensive knowledge is part of an ability to adapt to the requirements of an ever moving pharmaceutical world. Driven by the search of always better compounds with increased potency, Sanofi’s chemists have adapted working methods and developed processes to achieve successful scale-up and industrial production with respect to product quality and production staff.

The handling of highly active products is more complex and limited to a small number of companies. Although there have been a growing number of organisations advertising HAP handling capabilities, only a few have demonstrated a real ability in this segment of API manufacturing. One reason for this is the amount of financial investment to design, operate, and maintain highly contained workshops and buildings.

All companies dealing with commercial HAPs know that an isolator itself is not the definition of a high-containment facility. There are multiple parameters that need to be considered in the manufacture of HAPs beyond the isolator and it is risky to rely on a company that would claim capabilities in HAP handling using isolators installed in workshops and not designed or upgraded with appropriate air flow and containment measures beyond the isolators.

Sanofi’s operating and safety philosophy in the HAP field is based on the concept of highly contained workshops including with the weighing room for starting materials, to the isolators and reactors, to the filtration equipment and the packaging room.

All production units are equipped with the latest technologies in isolators, glove boxes, vessels, and drying equipment. Suites are fully or partially segregated with restricted access with personnel entrance and exit through airlock systems satisfying the most stringent requirements for products and personnel protection.Production units operate in ISO 7 classification/class 10000 for OEB 4 and OEB 5 compounds and are regularly inspected by Health Authorities, such as the Food and Drug Authority (FDA), European Medicines Agency (EMA) and pharmaceuticals and Medical Devices Agency PMDA).

A total of almost 40 reactors ranging from 5l to 1,000l (glass, glass-lined, stainless steel, and Hastelloy) are dedicated to this activity, as well as multiple filtration options (filters dryers and Nutsch filters) with material compatibility (stainless steel, Hastelloy).

In addition, chromatography equipment with two preparative high-performance liquid chromatography (HPLC) columns (Ø 450mm and 200mm) are used for purification of high-potent compounds (OEB 5).

Furthermore, a development unit for physical properties and crystallisation of highly actives is available. Milling equipment installed in isolators in a contained building allows us to provide milling and micronisation services for OEB 5 compounds.

As important as state-of-the-art equipment and facilities, manpower and specialised training are very important key parameter in a company’s ability to safely handle highly active compounds.

Working in a contained environment requires a workforce well trained in areas of personal protective equipment, operating procedures in industrial hygiene, quality procedures for cleanings, decontamination, adaptation to new equipment and many others that are ruled by operating procedures continuously updated from latest industry trends in technology or trends in quality and hygiene.

The total staff for the Sanofi HAP unit is 80, working in one or two shifts. Sanofi uses the occupational exposure banding system index from 1 to 5 relative to the product toxicity, corresponding to the to the occupational exposure limit (OEL) range:

  • OEB OEL range (μg/m3)
  • OEB 1 1,000 – 5,000
  • OEB 2 100 – 1,000
  • OEB 3 10 – 100
  • OEB 4 1 – 10
  • OEB 5 <1

In fact, Sanofi has the highly specialised ability to handle HAPs with a single-digit nanogram/m3 exposure limit. We have qualified several of our isolators to satisfy recent requirements.

Our internal team of experts in industrial hygiene can assess OEB categorization for API and upstream intermediates in order to use HAP equipment only when necessary to minimise costs.

We are committed to sharing our scientific knowledge and experience in pharmacology and toxicology to support your projects.

The high quality standards that have helped to make Sanofi a leader in pharmaceutical science are essential in the manufacture of HAPs. Four quality control labs are dedicated to the testing of high-potent starting materials, as well as the development and transfer of analytical methods for in-process controls and for the release of the final drug substance.

The company’s quality system is regularly inspected and audited by customers and regulatory authorities and it claims more than 15 years of proven track records of success. CEPiA has much to offer in the CMO space. Its HAP customers will benefit from the same world class large pharmaceutical facilities and expertise that are used to manufacture.

In addition to decades of expertise, a commitment to quality and respect for industrial hygiene, safety, and the environment, CEPiA can provide fill and finish services and a one-stop-shop solution for highly active and cytotoxic projects.

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