A biological molecule becomes an approved drug product through a series of deliberate decisions that expand formulation and production. We help you make the right ones.
Drug Product Development
Your molecule becomes a Drug Product with us
Drug Product Development
Your molecule becomes a Drug Product with us
A biological molecule becomes an approved drug product through a series of deliberate decisions that expand formulation and production. We help you make the right ones.
DEVELOPMENT MATTERS
In biologics, the decisions made during Drug Product Development — how a molecule is formulated, stabilized, and prepared for manufacturing — shape everything that follows: the quality of your clinical batches, the strength , and ultimately, your path to approval.
At Archivel, we bring scientific know-how, manufacturing awareness, and regulatory experience to make sure those decisions are made right.
What molecules do we cover?
Our expertise covers a broad range of biological molecules, including:
Vaccines
Oncologic vaccines
Peptide and Proteins
Antibodies
Cell-derived products
Innovative products
Vaccines
Peptide and Proteins
Cell-derived products
Oncologic vaccines
Antibodies
Innovative products
Formulation
We work through the critical variables systematically: excipient screening and selection, pH and buffer optimisation, concentration and solubility studies, and real-time and accelerated stability studies to characterise shelf-life behaviour.
Where lyophilization is required — or where it is the right strategic choice for your molecule’s stability profile — we integrate freeze-drying cycle design from the outset, not as an afterthought.
Container closure selection, whether vials, syringes, or cartridges, is treated as part of the formulation decision, not a downstream detail.
Process Development
From the earliest development stages, we define manufacturing processes that are compatible with GMP production — at the clinical scale your program genuinely needs.
We work with you to establish the critical process parameters that govern your filling process: fill volume, fill speed, container format, and stopper compatibility.
If you are starting without a defined manufacturing process, we design it for you, building from your formulation and molecule characteristics, with GMP clinical manufacturing as the endpoint.
If you already have a process developed elsewhere, we manage the tech transfer into our platform, assess its GMP compatibility, and adapt it where necessary so it can be executed reliably under our conditions.
Regulatory Compliance
At Archivel, every step of the development process is executed and recorded to GMP standards: analytical methods developed and validated per ICH, PhEur, and USP guidelines, batch records maintained with full traceability, and deviations managed and documented in compliance with GMP requirements.
When the time comes to build your dossier, you won’t be starting from scratch. We will be by your side — providing the data, the documentation, and the technical input your submission requires, so you can move through the regulatory process with confidence.
