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Emerging Trends in Single-Use Technology in the Manufacturing of Antibody-Drug Conjugates

Emerging Trends in Single-Use Technology in the Manufacturing of  Antibody-Drug Conjugates +

Single-use technology, designed for the manufacturing of biopharmaceutical products, has made major inroads over the last 30 years. First introduced in the late 1970s in the form of disposable capsules and a range of filters, single-use technologies were revolutionized in the late 2000s with the introduction of single-use 2D and 3D process containers and filter assemblies for mixing and storage systems. Today, these technologies have been adopted across the upstream manufacturing process, downstream purification and fill-finish of entire classes of biologic drugs. Article by: Karen Green MBA, Mary Robinette PMP, Gang Yao Ph.D and Nicholas Landry MBA

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Evolution of Antibody-Drug Manufacturing

Evolution of Antibody-Drug Manufacturing +

Antibody-drug Conjugates (ADCs) have evolved since the initial approval of gemtuzumab ozogamicin (Mylotarg®) in 2000, with respect to conjugation, linker and toxin chemistries and processing. With the current availability of 4 commercially approved drugs and approximately 80 programs in various clinical trials, there has been a significant interest in simplifying the complex supply chain.

With approximately 80% of the programs outsourced to Contract Development and Manufacturing Organizations (CDMOs), a transparent and integrated supply chain is critical for the success of ADC projects.

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Worldwide Supply Chain Advantages

Worldwide Supply Chain Advantages +

Just over a decade ago, the pharmaceutical industry and R&D in China was dominated by generics and plagued with insufficient technical capacity and fewer investments at the initial stage of novel drug development.

China’s entry in the global pharmaceutical R&D industry started relatively late, substantial government support and a thriving economy, has changed the industry. In recent years, the country, as a whole, has achieved colossal success in building a modern industry.

China’s success is, in large part, the result of the countries Thousand Talent program, a 2008 government initiative targeting Chinese-born academics and workers who trained overseas – in the United States and Europe - and encouraging them to ‘come home’ with promises of grants and tax breaks.

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Four Ways to Show Nonobviousness of ADC Inventions

Four Ways to Show Nonobviousness of ADC Inventions +

When the first antibody-drug conjugate (ADC) was approved by the U.S. Food and Drug Administration (FDA) in 2000,[1] only a handful of patent applications claiming ADCs had been published.[2] As research continues to progress and the scientific community’s appreciation for the power of ADCs has grown, so have the numbers. FDA has now approved at least four ADCs,[3] and hundreds more are in development.[4] The number of patent applications has also grown, with the U.S. Patent and Trademark Office (USPTO) publishing over two hundred patent applications with claims to ADC inventions in the last two years alone.

But filing an application with the USPTO does not guarantee that a patent will be obtained. Among other requirements, inventions worthy of U.S. patent protection must not have been obvious to a person of ordinary skill in the art at the time of invention...

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ADCs - Look Forward to a Potent Future

ADCs - Look Forward to a Potent Future +

One of the factors that has held back the wider use of ADCs as therapeutics is the difficulties encountered in striking a balance between payload efficacy and dose-limiting toxicities in off-target tissues. According to a survey of papers in the literature where ADCs with the same linker/payload but different drug-to-antibody ratios were dosed such that the amount of payload delivered was held constant but the amount of antibody varied, it appeared that dosing with more antibody resulted in improved efficacy.[1] This improvement may have been due to better ADC tumor penetration, which in turn may point the way towards improving efficacy outcomes without dosing more drug, thus widening the therapeutic window. If this is the case, then there are implications for preclinical, and perhaps clinical, study design.

Another area that is gaining increasing attention is the potential of the adaptive immune system to augment or complement in vivo efficacy of ADCs, particularly with respect to testing combination therapies of ADCs dosed along with checkpoint inhibitor drugs.

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