Generic APIs

Seqens offers world-class drug Substance development and manufacturing services to the pharmaceutical industry. Benefit from a manufacturing network of 7 cGMP plants located in Europe, Israel and in the United States with a strong regulatory track record with international health authorities and  the best workshop & expertise in specialized technologies 

Seqens has an in-house IP team for the design of non-infringing patent process to assure the customer the freedom to operate on the target market at the desired launch. But our target is not only to be the first but also to last to be part of the long-term success of the project. That’s why in addition to patent-free we develop cost competitive products by incorporating original technologies and working on the last array of chemistries where Seqens has a strong knowhow.  

API Development and Production

Seqens: a trusted supplier of APIs 

With 1 000/m3 of cGMP production capacity, 130 R&D chemists and seven pilot units providing first class R&D capabilities, and proprietary technology, such as biocatalysis, to develop unique processes, Seqens has the capacity and competence to develop your API project successfully, to scale up production as needed, and to handle regulatory filings at every stage and in all markets.

We offer a dependable manufacturing network of five cGMP plants in Europe and one in the United States, all of which have a strong track record dealing with the Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) and the Pharmaceuticals, Medical Devices Agency (PMDA) in Japan and other international regulatory agencies.

More than 50 APIs have been successfully launched in the United States, Europe and Japan with consistently superior quality, reliability and customer service, and supported by regulatory documentation to meet the most stringent standards from local agencies.

In house back integration for starting API materials

Additionally, to minimize the impact of variability in the quality of raw materials on production timelines and regulatory approval, Seqens has several pre-GMP sites that provide supply security with back-integration of raw material and regulatory starting materials. Without having to depend on third parties, we can obtain advanced intermediates in the necessary quantities for your project, while also controlling cost of critical materials. 

Multisite backup production of an API

Several GMP compliance production sites, Seqens can offer an additional level of supply security by offering the possibility of incorporating another site for the API production.

Key expertises for APIs manufacturing

API solid Form

Seqens offers crystallization and polymorph identification at all stages of drug development.

From both the IP and technical point of view, the success of a new API project depends on solid-form changes during drug development. Crystalline polymorphs have different melting points, solubility, dissolution rates and other physical properties that affect bioavailability, first pass metabolism and toxicity, as well as chemical and physical stability.

Seqens has the industrial experience to manufacture API polymorphs in a stable and reproducible manner, and offers the convenience of partnering with you to customize particle size distribution to your specifications.

In addition, Seqens has significant expertise in developing chiral pure APIs from its existing catalogue of racemic APIs, and can apply our processes to racemic molecules produced by other manufacturers. 

Solid state science drug development track record:

• Baclofen/R-Baclofen
• Cinacalcet synthesis
• Esomeprazole trihydrate/dehydrate

Spray-drying

Low aqueous solubility of active pharmaceutical ingredients (APIs) often translates to poor bioavailability that can be a cause of failure during drug development. As such, improved aqueous solubility is a primary objective of formulation development, especially for oral, inhaled, and topical drug treatments. Spray drying is an established particle engineering technology that involves producing dry powders from a fluid material through atomization into a hot drying gas medium, usually air or nitrogen. It offers several advantages over other particle engineering technologies, not least the capacity for continuous operation that removes any limitations on batch size. Other benefits of spray drying include rapid, scalable, cost-effective operation, and implicit compatibility with process analytical technology to safeguard highly reproducible drug production. Spray drying is also more controllable, especially in the hands of an experienced API CDMO.

Micronization 

The micronization of APIs is increasingly becoming a key capability for Contract Development and Manufacturing Organizations (CDMOs) as demand for semi-solid drugs, creams and gels continues to grow, as well as the use of APIs in foodstuff ingredients.

Micronization is a process for reducing the diameter of a solid material’s particles to enable the solubility of Active Pharmaceutical Ingredients (APIs). Whether administered orally or topically,  this solubility is a key factor in bioavailability, and ultimately, the effectiveness of a drug.

Drug substance Regulatory Affairs and Quality Assurance

On your behalf, Seqens will file the Active Substance Master File (ASMF), Certificate of Suitability (CEP), Drug Master File (DMF) and other regulatory documents containing relevant details of the manufacturing process. It enables the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other international pharmaceutical regulatory agencies to review process information in support of third-party drug product marketing applications. Upon request, we will also provide a letter of authorization/access to allow such agencies to review the DMF.

Seqens has an in-house Regulatory Affairs team that includes 30 Quality Assurance staff members handling more than 80 active DMFs. Additionally, in countries where the process patent remains in force, our in-house IP team can also design non-infringing patent processes that allows you to launch a new formulation faster. Your formulations will be cost-competitive, because Seqens has deep experience with incorporating original technologies and working with final chemical microarrays.