Closing Chemical Dots in Pharma Industry
AuxiliS Consult is your reliable partner at every stage of chemical development for small molecule API’s, intermediates and raw materials. Our business is built around a few core activities which will support your company in its daily chemical endeavors.
Core Expertise: Chemical Process R&D
Chemical Process R&D activities are carried out between the selection of a promising lead API by Medicinal Chemistry until its registration by health authorities. The typical quantities of API involved vary from gram to ton scale. The same questions need to be addressed at each stage of the clinical development, and the answer can differ dramatically from phase to phase:
- Which resources (FTE and OOP) do we need?
- Do we have fit-for-purpose chemistry?
- Which documentation do we need?
- Which interactions do we want between synthetic chemistry, analytical chemistry and formulation development?
- Connection with CRO/CDMO
- Synthesis evaluation
- Transformation into “scalable” synthesis
- Connection theoretical/practical aspects
- COGs estimates
- Supplier Selection
- Supplier Qualification
- Competitive Bidding
- External Innovation
- Connection with CDMO/CMO
- Preparation of the validation campaign
- Preparation of the QA documentation (e.g. Criticality Analysis…)
- Preparation of the dossier (RA)
All these questions can be addressed by AuxiliS!
Activities
Each project requires appropriate organization, based on the applied science and the people involved. The key challenge is that everyone knows what to do and does it, in alignment with the project timelines.
These activities can be carried out by internal people, but some companies prefer to focus on science and lab experiments, and leave more organizational tasks to an external consultant.
Smaller companies may also outsource all activities to an external partner, named CRO (Contract Research Organization) combined or not with a CMO (Contract Manufacturing Organization). At this stage, it is critical to have a reliable partner with an expert eye on all these activities and who can drive them in the interest of the customer.
There as well, AuxiliS has an important role to play to keep your business safe!
These activities can be time-consuming for your business, and you don’t have these resources internally. You can take advantage of my broad experience to understand and (re)shape the competitive features of your company, to compose an appropriate presentation package, and to present your activities to selected audiences.
Again, a role where AuxiliS can add value to your company!
Your company realizes that some gaps in personnel trainings should be filled, but you don’t have internal resources to this. Why wouldn’t you rely on external workforce to perform this task? Again, my experience can be used at the service of your needs. As a passionate teacher at various universities in Belgium, I can give different trainings which will help filling the gaps in the following topics:
- Introduction to chemical process R&D
- Introduction to chemistry and chemical concepts for non-chemists
- Impurity management (incl. nitrosamines)
- Introduction to Quality concepts – Overview of ICH guidelines and application in Pharma industry
- Introduction to Prodrug Technology
- …
We can discuss you needs and tailor specific trainings for your collaborators. Again, a task for which you can rely on AuxiliS!
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About
AuxiliS Consult was founded in January 2024 by Michel Guillaume.
The company intends to provide extensive support for Chemical Development activities of diverse companies.
Michel Guillaume completed his PhD in Organic Synthesis at the “Université Catholique de Louvain” (UCL) in 1994 where he contributed to novel syntheses of heterocyclic compounds.
The same year, he joined the Chemical Development department at Janssen Pharmaceutica (Johnson & Johnson) in Beerse (Belgium).
He led since then more than 30 multi-disciplinary project teams including process research, kilo-lab, pilot plant, analysis, particle engineering, safety testing, quality and chemical manufacturing.
He’s the author of several papers and process patents.
Michel Guillaume
In 2012, he joined the Procurement Department to perform qualifications of suppliers, to streamline supplier qualification processes and to foster external innovation from suppliers.
In 2014, he joined the Chemical Post-Approval Support Department where he supported marketed Chemical Production processes. He also led late-stage development projects, like the 3rd generation process for Darunavir (approved in 2019); more recently, he led the Aprocitentan project (collaboration with the Swiss biotech Idorsia), which resulted in the filing of the molecule early in 2023.
Michel Guillaume is also guest Professor at the University of Antwerp (UIA) and Brussels (VUB) for courses on Chemical Process R&D and at the University of Louvain (KUL) for a course on Prodrug Technology.
