Phasing forward with Seqens

Three custom development and manufacturing organizations – PCAS S.A. in France, Chemie Uetikon in Germany and PCI Synthesis in the United States – have joined forces as Seqens CDMO (formerly Novacap) to offer world-class Drug Substance Development and Manufacturing services to the pharmaceutical industry.

WHO IS SEQENS CDMO?

With three R&D centers, six cGMP / FDA inspected production sites in Europe and the United States supported by two manufacturing sites for the production of critical intermediates and Regulatory Starting Materials (RSMs), the group offers a powerful manufacturing network employing approximately 1200 persons capable to embrace complexity in developing, industrializing and manufacturing complex molecular entities.

WHY SEQENS CDMO?

Combined into one organization, Seqens brings several strong differentiators:

1. Experience

• PCAS, established 1962.
• PCI Synthesis, established 1998.
• Uetikon, incorporated 1991.
• Novacap, created 2003.

2. Critical mass in R&D to navigate the growing molecular complexityto enable the next generation of small molecules breakthrough therapeutics.

With 300 scientists working at two R&D primary facilities, the Paris-Porcheville global R&D center in France is capable of supporting global customers from clinical phase to market launch while the Devens-Newburyport labs, near Boston, primarily focuses on pre-clinical to Phase 2 development of small molecules drug candidates.

These primary R&D centers are supported by specialized R&D teams focusing on key technologies or expertise including:

• Gene engineering and biocatalysis at Protéus in Nîmes, France;
• Complex chiral chemistries and amino acids derivatives in Lahr, Germany; and
• Polymer chemistry for pharma in Aramon, France.

3. Critical mass for Quality and Regulatory Compliance to meet the growing expectations of health agencies like the FDA.

With two to three FDA inspections on average per year, Seqens is in position to monitor the latest trends from agencies and anticipate their future requirements.

4. Expertise in solid state properties and crystallization to facilitate Drug product Development.

Seqens‘ expertise in API development is bridging the gap with drug product development through its specialized solid state and crystallization laboratories in Paris-Porcheville and Devens-Newburyport.

We can bring the concept of one-stop shop to API development, which is beneficial in understanding drug product development constraints related to an API’s physical properties. Additionally, by working within one CDMO, customers can reduce risks and delays and limit extra costs because we spend a lot of effort in ensuring a smooth handoff along the way.

Seqens offers the appropriate scientific capabilities to perform crystallization studies, polymorph identification, salt selection or solubility determination to understand a drug’s molecule physicochemical profile.

5. Strong capabilities in special technologies and potent API manufacturing

Besides solid development and scale-up capabilities, SEQENS offers a strong platform in special capabilities:

• Low temperature chemistry down to -80 °c:  in Aramon, Limay and Couterne in France,

Lahr, Germany and Newburyport, U.S.

• Multi-ton scale potent API handling with OEL down to 0.1 µg / m3 for raw materials or final drug substances.
• Very high-pressure reactions up to 100 bars.

Overall Seqens is one of the largest players in Europe for several key technologies like cryogenic chemistry, hydrogenation or Friedel-Crafts reactions.

6. A flexible and multi-faceted production network

With eight manufacturing sites to support its CDMO Business Unit, Seqens is capable to offer agility and a continuum of capabilities from kilogram to multi-ton scale. This network benefits from the industrial, engineering and capital expenditure capabilities of the whole Seqens group, which has 3,200 employees and 24 manufacturing sites worldwide, including large volume dedicated API sites in China, Thailand and France. The group can offer a continuum of capacity, from very small scale to potentially dedicated production workshop.

It is particularly important to not only focus on large volume APIs but also to be capable of properly handling small scale production since novel drugs to treat orphan diseases appear to be a growing area of development with a record 58% in 2018 of new drugs approved by the FDA.

Source: U.S. FDA’s 2018 New Drug Therapy Approvals report, page 10.

CONCLUSION:

While the cost of developing a new drug is estimated to be over $1.5 billion by industry experts, innovators need to rely on experienced and multi-faceted CDMOs capable to move forward from early clinical phases to commercial launch and beyond.

Combined, Seqens CDMO offers critical size of scientific and technical capabilities to address the increasing complexity of new chemical entities to development is now necessary in a highly regulated environment and under tight timelines.

In addition, we look to drive efficiency, speed and productivity all along the API lifecycle through a long-term partnership with pharmaceutical companies.

While offering these strengths on a global basis, Seqens is also designed to stay agile and to set up professional teams to fit with our customers’ organizations to take their projects to the next level. We have local teams in the U.S., France and Germany who are accessible and accountable.

Didier Combis
Commercial Director, Seqens CDMO