Peer Reviewed

Big Data in Science: Which Business Model is Suitable?

1.0 Abstract The first aim of this paper is to define which Big Data business model (in science-based activity) will...
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New Learning Makes ADC Development Less Empirical

A few decades ago, the pharmaceutical industry developed and commercialized racemic small molecule drugs. Despite the success achieved with...

Utilization of Breakthrough Therapy Designations for Market Access

In the pharmaceutical marketplace, time-to-market is crucial, with companies seeking viable strategies to help hasten the review process in...

Downstream Processing Considerations for Antibody Variant Therapeutics

Abstract Novel platforms such as antibody derivatives, peptide based therapies, gene and stem cell based therapies are gaining foothold in...

Addressing Dendritic Cells for Anticancer Immunity

By addressing the body’s own immune system the treatment of several severe diseases, e.g. infectious diseases, has become incredibly successful throughout the last centuries. Thus, it is highly desirable to adopt this concept to other diseases as well. Recently, cancer immunotherapy has become an alternative route to treat malignancies effectively without adverse side effects that are usually caused by classical cytostatics.

The Clinical Landscape of Antibody-drug Conjugates

Antibody drug conjugates (ADCs) are a class of therapeutics that combine the selective targeting properties of monoclonal antibodies (mAbs) with potent cell killing activities of cytotoxic agents. Given rapid pace of progress in this field, it is important for drug developers to have a high level view of the landscape of ADCs in the clinic. This review analyzes ADCs tested in the field of Oncology. Trials are evaluated by cancer type, trial status, phase, and characteristics of the ADC.

Challenges and Strategies for the Downstream Processing of BiSpecific Antibodies (BsAbs)

Baeuerle and Raum present an extensive review of BsAbs in their article. [2] BsAbs are most commonly used for cancer immunotherapy where they are targeted to simultaneously bind to a cytotoxic cell as well as a target tumor cell to be destroyed. Targeting two antigens simultaneously can be a promising approach. This paper will include a review of the challenges associated with the manufacturing of BsAbs in mammalian cell cultures, and the strategies that can be implemented to overcome treatment challenges.

Successful Strategies in the Development and Technology Transfer of Antibody-Drug Conjugates

In this article, Cynthia Wooge, Ph.D., discusses the requirements of a properly designed technology transfer process and how to ensure a successful transfer and reproducible conjugation process with solid analytics, appropriate engineering design, process (quality) controls and quality assurance. She emphasizes the need to understand which details are critical and how they get effectively communicated between the various parties involved in the transfer process.

Making Hot ADCs

Guided by a specific monoclonal antibody (mAb), antibody drug conjugates or ADC are a new, emerging, class of drugs able to deliver a drug payload directly to an intended target. This approach has recently been boosted by the U.S. Food and Drug Administration approval of brentuximab vedotin (Adcetris®; Seattle Genetics) to treat Hodgkin’s lymphoma and ado-trastuzumab emtansine (Kadcyla®; Genentech) for metastatic breast cancer. These new biotherapeutic drugs will bring many regulatory issues to the forefront regarding the ADME (Absorption, Distribution, Metabolism and Excretion) profile of each ADC. In this article, the authors discuss this and other important aspects of antibody-drug conjugates.

Consideration for the Safe and Effective Manufacturing of Antibody-drug Conjugates

Antibody drug conjugates are an emerging class of biotherapeutics which require unique supporting infrastructure to meet bio/ pharmaceutical industry standards for safe, effective and reliable manufacturing. These highly potent biopharmaceuticals present a series of unique manufacturing challenges driven by their potency and raw material supply chain. Facility design must take into consideration these manufacturing challenges to insure employee safety and robust process performance. The concepts addressed in this article convey the experience gained by Lonza during our years working with this class of biotherapeutics.