Methodology for assessing Repligen ProStream® and HyStream® Tangential Flow Filtration Cassettes in an Antibody-Drug-Conjugate...

Antibody-drug conjugates (ADCs) is a growing field requiring specific handling due to the highly potent drug or highly active pharmaceutical ingredient (HAPI). The generic...

The Highs, Lows, and Resurgence of Antibody-drug Conjugates

Antibody drug conjugates (ADCs) offer a way to deliver a cytotoxic or an immuno-stimulatory payload directly to tumors to maximize the anti-tumor efficacy of the payload with reduced systemic toxicities. The development of ADCs has occurred over several decades. ADCs have been through several highs and lows where there was substantial excitement for the promise ADCs hold only to be followed by disinterest when there were disappointing results in the clinic. This resulted in several companies abandoning their internal ADC development efforts. Twelve ADCs globally have been approved to treat hematologic or solid tumors. The renewed interest in ADCs, is due, in part, to the recent clinical success of ADCs, the development of improved ADC technologies, and the identification of new ADC targets.

Validation of ADC Platform for Protein Concentration and the Drug-Antibody Ratio (DAR) using Variable...

Antibody Drug Conjugates (ADCs) are biopharmaceutical drugs which are designed to treat cancer by targeting and killing the cancerous cells while leaving the healthy...

Unlocking the Potential of Antibody-drug Conjugates

One hundred years ago, Paul Ehrlich*, a German biochemist and Nobel laureate who created the field of chemotherapy, coined the term “magic bullet.” He...

AJICAP Second-generation: Realizing Versatility and Robustness through Fc-Affinity Guided Chemical Conjugation Technology

Over the past decade, site-specific chemical conjugation has emerged as a promising strategy to produce antibody-drug conjugates (ADCs) in the field of oncology [1]. Daiichi-Sankyo's chemical conjugation method, which uses high drug-to-antibody ratio (DAR) technology, was approved by the U.S. Food and Drug Administration as the first site-specific ADC (fam-trastuzumab-deruxtecan-nxki; Enhertu® | Daiichi Sankyo and AstraZeneca).

Bioconjugation Technology Selection during Early-Stage Development – A Strategy to Streamline IND and Manufacturing...

Abstract Bioconjugate therapeutics comprise a fast-growing class of drugs with applications in various disease areas. In the past years, particularly antibody-drug conjugates (ADCs) have undergone...

How Process Enabling Closed Systems Offer Maximum Safety in ADC Manufacturing

Since Antibody-drug Conjugates (ADC) are already approved for the treatment of relapsed Hodgkin’s lymphoma, HER2-positive metastatic breast cancer and B cell lymphoma, among others, high expectations are placed on this class of bioconjugates. Indeed, more than 100 different ADCs have been studied for various applications by 2022, presumably with several more to follow.

Automating ADC Manufacturing with Electricity

Combining the specificity and stability of antibodies with the potency of small molecules has always been at the core of the antibody drug conjugate (ADC) field. The technological challenge to this therapeutic approach is in bringing two disparate molecules in union with one another. Once this was achieved, the next technological hurdle was, in essence, automation

Advances in the Development of Dual-Drug Antibody Drug Conjugates

Antibody drug conjugates (ADCs) are touted for their ability to site selectively deliver a small molecule chemotherapeutic directly to a tumor cell, bypassing off target side effects from systemic circulation. To date, eleven ADCs have been FDA approved in the United States and >200 more in the clinical pipeline (clinicaltrials.gov).

Recent Advances in Antibody-drug Conjugates Produced Using Chemical Conjugation Technology

To date, more than 10 antibody-drug conjugates (ADCs) have been approved by the U.S. Food and Drug Administration (FDA) and contribute to the medical community.