⏩ Initially seen as difficult to produce quickly and affordably, now more than 150 antibodies are on the market.
⏩ Gene and cell therapies are following a similar path to mAbs and have huge potential.
⏩ With a “can-do” attitude and the application of mAb experience, manufacturers are accelerating advancements in advanced therapies.
⏩ Regulators are also becoming more flexible in their approach to ensure patient safety.
⏩ Future developments include new classes of drugs and the development of more effective antibodies based on patient studies.
Introduction:
Monoclonal antibodies (mAbs) were once considered difficult to produce quickly, efficiently, and at low cost. However, advancements in the production of mAbs over the past 30 years have paved the way for rapid progress in advanced therapies. Paul Varley, senior vice president of development at Alchemab Therapeutics, believes that the history of mAb development holds valuable lessons for manufacturers of promising therapies, such as CAR-T. The can-do attitude and technological advancements in the mAb field have enabled faster production and improved process analytics, which can now be applied to advanced therapies. Regulatory agencies are also becoming more flexible, taking a risk-based approach that prioritizes patient needs. Varley also discusses the future of antibodies, including the development of new classes of drugs like antibody-drug conjugates.
- Advancements in the production of monoclonal antibodies (mAbs) over the past 30 years have paved the way for rapid progress in advanced therapies.
- The history of mAb development holds valuable lessons for manufacturers of promising therapies, such as CAR-T.
- Technological advancements in the mAb field, including improved process analytics, can now be applied to advanced therapies.
- Regulatory agencies are taking a more flexible, risk-based approach to therapy approvals.
- The future of antibodies includes the development of new classes of drugs like antibody-drug conjugates.
Conclusion:
The can-do attitude and technological advancements in the production of monoclonal antibodies have set the groundwork for rapid progress in advanced therapies. Manufacturers of promising therapies can learn from the history of mAb development and apply those lessons to improve the production and efficiency of advanced therapies. Regulatory agencies are also becoming more flexible, which allows for a faster approval process. The future of antibodies includes the development of new classes of drugs that hold great promise for transforming medicine.
