NCEs
"We support our customers from the initial stages of development to the manufacturing of commercial quantities of APIs, intermediates thereof, and pharmaceutical intermediates".
Our Core Team system establishes the involvement of all relevant staff as of the early stages of the project (from R&D/Manufacturing/Quality to EHS/Procurement), addresses all potential roadblocks in your project, and proposes long-term solutions.
Our proactive staff has been involved in more than 20 NCE customer filings since 2007, with an outstanding success rate (all projects were approved by authorities without any setback related to the manufacturing of the drug substance).
Our Experience: Supporting Customers with their NCE Filings
| Therapeutic Category | Company | Markets | |
|---|---|---|---|
| 2007 | Quinolone | Japanese Company | Japan |
| 2010 | Antihypertensive | Japanese Company | Worldwide |
| 2011 | Anticancer Antigout |
Big Pharma Company Japanese Company |
Worldwide |
| 2011-2013 | Antiretroviral Cystic Fibrosis Therapy |
US Biotech | Worldwide |
| 2014 | Antiretroviral Cystic Fibrosis Therapy Antihypertensive |
US Biotech Japanese Company |
Worldwide Japan |
| 2015 | Antiretroviral | US Biotech | Worldwide | 2016 | Antipsoriasis | US Biotech | Worldwide |
| 2017 | Antiretroviral Anticancer Cystic Fibrosis Therapy |
2 US Biotechs | Worldwide |
| 2018 | Antiretroviral | US Biotech | Worldwide |
| 2019 | CKD Anemia Anticancer Hematologic Malignancies Cystic Fibrosis Therapy (2) |
3 US and 1 Japanese Biotech | Japan USA USA USA |
| 2020 | CDA Inhibitor | Japanese Company | Worldwide |
| 2022 | Antiviral Anticancer |
Global Pharma Japanese Company |
Worldwide USA |
23 NCE's FILINGS 2007-2022 (including submitted with pending authorization)
Our people's strong involvement in the projects and our policy to have a low number of new customers per year (not more than two customers per year are usually added) allows full dedication to your project.
Process development
Our Global R&D Department is responsible for the industry-oriented Process Development of all new products, and has capability to support the industrialization of these products in the three continents.
Simultaneous chemical and analytical development, scale-up under cGMPs, and transfer and validation services, are provided. Core teams are set up for all incoming projects, from evaluation to validation. Business Development and Regulatory are also involved during the entire development process
"New Development Concepts", such as PAR, QbD, DoE, process simulation, etc., are taken into account during development, with special attention paid to the solid form of the final API (particle size, polymorphism...).
Our R&D team also supports product validation and industrialization by preparing QRAs, HAZOPs, etc.
Since 2007 the R&D team has been involved in more than 20 NCE customer projects carried out through commercial manufacturing.
Project management system
It is known that one of the factors of success of a project lies on effective communication between all participants.
We at Esteve Química decided to establish Core Teams to manage our projects more effectively. These Core Teams are inter-disciplinary groups, established at the inception of the project, that follow the project throughout its life, from lab trials, scale-up and validation to marketing.
Core Teams are composed of people from R&D, manufacturing, quality, EHS and purchasing, thus allowing addressing all potential roadblocks in the project and proposing long-term solutions.
Technical communication with the client is assured through the Core Team Leader figure, with regular meetings (teleconference, face to face…) held to meet customer needs and solve problems fast.
Supporting customers to bring innovation to patients: Case Study.
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