Biologics and Conjugates CDMO Services - PORTON

Efficacy and Safety - Guidelines for Clinical In-use Stability Studies of ADCs

Antibody-drug conjugates (ADCs) consist of three parts: antibody, linker, and payload. This special combination enables ADCs to selectively target tumor cells and release cytotoxic drugs, but they face many stability challenges during manufacture, storage, and clinical use. In this paper, the drug product development team at Porton (hereinafter referred to as "we") discusses the necessary clinical in-use stability studies for ADCs.

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Overview and Case Study of Antibody Oligonucleotide Conjugates (AOC)

In the field of biomedical science, technological changes are common and constantly evolving. In recent years, antibody oligonucleotide conjugates (AOCs) have attracted considerable attention in the industry as an innovative and advanced biomedical method, and more and more domestic and foreign biopharmaceutical companies have participated in the research and application of AOCs. Because AOC combines the advantages of oligonucleotide technology and antibodies, it is considered to have the potential to provide precise targeted therapy and is expected to bring about a revolution in the biomedical field.

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Co-processing: Co-Precipitation Technology (CPT) for the Enhancement of Flowability and Bulk Density

Formulating compressed tablets is one of the most widely used oral solid form dosages. However, a vital first step is choosing a suitable manufacturing approach and the right excipients to support the desired therapeutic effect.

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An ADC's Path to Market-Analysis of Difficulties and Key Points in ADC Process Scale up

An Antibody-Drug Conjugate (ADC) is a novel therapeutic agent which can deliver a highly-potent traditional small molecule drug to a specific site or cell within the body. It is formed when an active drug (the payload) is connected to an antibody using a linker. The complex is referred to as an ADC and it uses the cellular specificity of antibodies to direct the payload and deliver to the active disease site within the cell. This enables ADCs to selectively treat cancer cells, tumor microenvironments, or other target cells, while reducing systemic, off-target toxicity. This targeted delivery of ADC agents has shown great promise and explosive growth in recent years.

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Co-processing Series: 4. Heterogeneous nucleation (HN)

In the context of crystallization, heterogeneous nucleation occurs when crystals form on a surface rather than spontaneously in the bulk solution, playing a crucial role in controlling crystal formation and growth. When applied to Co-processing, heterogeneous nucleation on the surface of excipients enhances material properties, allowing for greater control over critical attributes such as flowability, stability, and polymorphism.

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Co-processing Series: 3. Adsorption

This method involves the absorption of a dissolved drug into the pores of a carrier material, known as an adsorbent, with the drug remaining embedded in the porous media post-drying.

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Co-processing Series: 2. ASD - How Co-Processing can replace Spray Drying

With spray drying, a prevalent method for producing amorphous solid dispersions (ASD), the process involves rapidly drying a solution with hot gas, resulting in high energy consumption and significant infrastructure and operational costs.

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Co-processing Series: 1. What is co-processing and how is the industry embracing it?

Co-processing enhances the flow and density properties of active pharmaceutical ingredients (API) thus simplifying oral solid formulation. In some cases, co-processing can be used to generate Amorphous Solid Dispersion and offers more expeditious alternatives to traditional methods such as spray drying, nano-milling, or hot-melt extrusion.

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