Biopharmaceuticals and Biologics

Biopharmaceuticals and biologics include protein-based therapeutics and monoclonal antibodies. This class of molecules has been immensely successful in the clinic for many therapeutic indications. Most protein therapeutics that are currently on the market are recombinant, with hundreds more in clinical trials to treat cancers, immune disorders, infections, and other diseases. Newly engineered proteins, including bispecific mAbs and multi-specific fusion proteins, mAbs conjugated with small molecule drugs, and proteins with optimized pharmacokinetics, are also under development.

Significant analytical testing is required to support a biopharmaceutical through its life cycle—from discovery, early development through stability, release testing, and clinical trials to manufacturing and marketing. Because of their size and complexity, a range of analytical methods are required to characterize these large molecules fully. The FDA requires orthogonal techniques (when available) to understand a biopharmaceutical’s structure and stability better. As the pipeline for these large molecules grows, CuriRx partners with pharmaceutical/drug manufacturers and use its wide range of analysis capabilities to fill voids in capacity or to meet timelines for their analytical testing.

Therapeutic proteins and antibodies can also be grouped based on their molecular type:

Antibody-based drugs
Fc fusion proteins
Blood factors
Bone morphogenetic proteins
Engineered protein scaffolds
Enzymes, growth factors

For these molecules, the services we offer include, but are not limited to:

  • General compendial testing
  • ICH stability storage and testing
  • Method development, qualification, and validation characterization
  • Mass determination
  • Peptide mapping
  • Disulfide bond mapping
  • N-Glycan
  • SDS-page
  • Western blot
  • Binding assay – Biacore
  • Endotoxin
  • Host cell protein analysis
  • Degradation
  • Aggregation
  • Oxidation
  • Deamidation
  • Size
  • Particulate
  • Developability assessment

Medicines from these classes of molecules are used as:

(a) Replacement therapy for a protein that is deficient or abnormal
(b) Augmentation of an existing pathway
(c) Providing a novel function or activity
(d) Interfering/blocking with a molecule or organism
(e) Delivering other compounds or proteins, such as a radionuclide, cytotoxic drug, or effector protein.