ANALYTICAL DEVELOPMENT
Analytical Services & Batch release
GMP-compliant analytical testing for biologics — method development, validation, and quality control.
Analytical Services & Batch release
GMP-compliant analytical testing for biologics — method development, validation, and quality control.
At Archivel, we develop and validate analytical methods across biological, physicochemical, and microbiological disciplines, working in accordance with ICH, PhEur, and USP guidelines.
Every method we develop is built with its end use in mind — whether that is supporting an IND or IMPD submission, underpinning in-process controls during manufacturing, or providing the analytical backbone for batch release.
Whether you are starting without any established methods, need to validate an existing protocol to GMP standards, or are transferring a client method into our laboratory, we adapt to your starting point.
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
Method Development & Validation
At Archivel, we develop and validate analytical methods across biological, physicochemical, and microbiological disciplines, working in accordance with ICH, PhEur, and USP guidelines. Whether you are starting without any established methods, need to validate an existing protocol to GMP standards, or are transferring a client method into our laboratory, we adapt to your starting point.
Test performed
Archivel Farma covers the full analytical scope your program requires, across biological, physicochemical, and microbiological testing.
Biological Analysis
Biological activity & potency
Protein characterisation
Nucleic acid analysis and quantification
Physicochemical Analysis
Physical characterisation
Chemical characterisation
Molecular & compositional analysis
Microbiological Testing
Sterility testing
Bioburden determination
Endotoxin testing (BET/LAL)
Environmental monitoring
Mycoplasma testing
Testing is performed using approved procedures, qualified or calibrated equipment, and predefined acceptance criteria, ensuring traceability, reliability, and data integrity throughout the analytical process.
Our analytical capabilities extend beyond what is listed here. If you don’t see a specific test or method your program requires, get in touch — chances are we can help.
Stability studies
Before a biologic can enter clinical trials, sponsors must demonstrate that the product maintains its quality, safety, and efficacy throughout its intended shelf life — under the storage conditions that will apply from manufacturing to clinical use. This data forms a critical part of the IND and IMPD submission and must be generated under ICH-compliant conditions to be accepted by regulatory authorities.
At Archivel, we perform stability studies covering real-time and accelerated study designs in accordance with ICH guidelines. For products already in clinical use, we also run ongoing stability programs for released batches — providing the long-term data that supports shelf-life extension and post-approval regulatory requirements.
Batch release
Clinical batch release by EU Qualified Person to clinical sites worldwide.
Manufacturing a biological drug product is only complete when it reaches the right place, in the right condition, at the right time. Batch release, storage, and distribution are the final steps in that journey — and for biological products, they are as technically demanding and regulatory-critical as everything that came before.
Batch release
Clinical batch release by EU Qualified Person to clinical sites worldwide.
Manufacturing a biological drug product is only complete when it reaches the right place, in the right condition, at the right time. Batch release, storage, and distribution are the final steps in that journey — and for biological products, they are as technically demanding and regulatory-critical as everything that came before.
