Anti-Biologic Drug Antibody Products

Biotech drugs, commonly referred to as biopharmaceuticals or biologics, are derived from or produced within living organisms. Biotech drugs are characterized by their substantial molecular weights and intricate structures. Their production entails an elaborate process necessitating multiple quality control stages to ensure consistency and reliability. Biopharmaceuticals encompass monoclonal antibodies, therapeutic proteins, nucleic acid products, vaccines, blood components, gene therapies, allergenic substances, cells, tissues, and more. These advanced therapeutics have received approval for the treatment of a diverse array of conditions, including cancer, autoimmune diseases, anemia, cystic fibrosis, diabetes, transplant rejection, and growth deficiencies.

Fig. 1 Notable progress in the advancement of protein-based therapeutics.¹

Types of Biotech Drugs

• Monoclonal Antibodies

Monoclonal antibodies (mAbs) represent a pivotal class of biotechnological therapeutics, extensively utilized in the treatment of various diseases, including oncology, inflammatory conditions, and autoimmune disorders. Presently, humanized mAbs are the most rapidly expanding category in clinical trials, serving as a significant catalyst for growth within the biopharmaceutical sector. These monoclonal antibodies are immunoglobulins meticulously purified from living cells. Numerous facets of mAbs, such as epitope specificity, immunogenicity, pharmacokinetics, and immune-related effector functions, constitute active research areas, emphasizing the ongoing advancement of antibodies for therapeutic applications.

• Therapeutic Proteins

In 1982, regular insulin was pioneering as the first approved protein-based drug. Since then, therapeutic protein drugs have emerged as formidable contenders, ushering in new paradigms in disease treatment, including areas such as cancer, autoimmune diseases, inflammation, infectious exposures, and genetic disorders. Proteins, as medicinal agents, can serve a multitude of roles including catalysts, signaling molecules, transporters of molecules and ions, scaffolds for maintaining cellular and tissue integrity, and receptors, among others. Compared to small molecule drugs, protein therapeutics are less likely to cause side effects by disrupting normal biological processes, as they have evolved to fulfill highly specific roles. Typically, these drugs exhibit high potency and are capable of performing more complex functions thanks to their intricate three-dimensional structures.

• Gene Therapies

Gene therapy is a cutting-edge medical innovation aimed at achieving therapeutic results by regulating gene expression or altering the inherent biological traits of living cells. This field includes strategies to repair or replace defective genes and to enhance tumor sensitivity to various treatments. As such, the potential of gene therapy in disease prevention and cure is considerable. It has demonstrated efficacy in treating rare genetic disorders, such as cystic fibrosis and familial hypercholesterolemia, as well as viral infections and cancer.

• Vaccines

Vaccines are biologically engineered products designed to safely trigger an immune response, providing protective immunity against infections or diseases following exposure to specific pathogens. They are generally categorized into live attenuated vaccines, inactivated vaccines, viral vector vaccines, nucleic acid-based vaccines (including RNA and DNA vaccines), and virus-like particle vaccines.

Anti-Drug Antibodies

Creative Biolabs offers a tailored service specializing in the development of anti-drug antibodies (ADAs) to support the clinical progression of biotherapeutic drugs or monitor drug levels in various specimens. Our high-affinity anti-drug antibodies are ideally suited for use in pharmacokinetic (PK) bridging ELISAs and serve as a reliable reference standard in anti-drug antibody (ADA) assays. For any inquiries or requirements related to ADAs, please do not hesitate to contact us.