Our comprehensive and flexible analytical solutions are compliant with regulatory requirements and well-designed to ensure the success of your biologic product.
Biologics are complex medicines containing active substances made by a biological process or derived from a biological source. “Biologics” is a broad term and encompasses a wide range of products such as hormones (e.g. insulin), enzymes (Enzyme Replacement Therapy), monoclonal antibodies (e.g. adalimumab), and vaccines (e.g. hepatitis).
The majority of biologics are produced in living cells such as human cells, animal cells or microorganisms using recombinant DNA technology methods. Biologics testing is a critical process during development and production as these large molecules are sensitive to and altered by changes in their manufacturing process and therefore quality, safety, and efficacy must be continually monitored and in order to meet strict regulatory requirements.
Within our state-of-the-art analytical laboratories at Almac, we offer services for GMP lot release and stability testing to support your drug substance and drug product programs for both novel biologics and biosimilars; fit-for-purpose method development and phase-appropriate method validation and raw material testing for microbial and mammalian expression systems.
All our activities are underpinned by a global cGMP quality system to support the development and launch of clinical and commercial biologics.
The Almac Advantage:
- Over 15 years’ product release experience adhering to industry regulations including FDA, EMA and PMDA
- Significant experience with biologics including biosimilars
- Utilising cGMP compliant phase-appropriate method validation and transfer
- Fast and flexible development of robust analytical methods utilizing Analytical Quality by Design (AQbD) principles
Meet the experts
Simon has over 25 years hands on experience managing multifunctional/multisite technical and support teams within CRO/CDMO and pharmaceutical industries. Simon has a PhD in Analytical Chemistry from Loughborough University, he is a chartered chemist and a Fellow of the Royal Society of Chemistry.
His experience lies with both small and large molecules in all of the GxP regulatory sectors from discovery and development, to manufacture, clinical analysis and commercial supply.
Pavan has a strong background in the field of analytical development for biologics, with more than 10 years of experience.
In his previous roles at Intas Biopharmaceuticals and Pfizer, he was responsible for leading a team of scientists to support analytical method development, validation and overall CMC strategy for advancement of early, late and commercial biologics. Pavan holds a M.S. degree in Biological Sciences from Arkansas State University.