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Biologics and Conjugates CDMO Services

As a subsidiary of Porton Pharma Solutions, a globally recognized CDMO, Porton Biologics and Conjugates CDMO Platform offers comprehensive, one-stop drug development and manufacturing services for biologics and conjugates, including ADCs, AOCs, PDCs, RDCs and more.

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Conjugates

  • Antibody-Drug Conjugate svgAntibody-Drug Conjugate svg1ADC
    Antibody-Drug Conjugate
  • AOC svgAOC svg1AOC
  • PDC svgPDC svg1PDC
  • PRC svgPRC svg1PRC
  • SMDC svgSMDC svg1SMDC

Targeting-vehicle

Antibody

Peptide

Small Molecule

Linker

Cys (-SH): S-S, Maleimide Group (mc, mcc, etc.)

Lys (-NH2): Activated Acid(CO-OSu, etc.)

Short Peptide (VC, GFGG, etc.)

PEG

Click Chemistry

pH-Sensitivity (HN-CH2-O-, C+N-NH=CO-, Hydrazine, Carbonate)

Multi Branches

Payload

Cytotoxic Drugs

Oligonucleotides

Radionuclides

Fluorescers

Early Stage Development

mg ~ g Scale Library

Developability Assessment

Process Development

Payload-Linker Process Development

Targeting-vehicle Process Development

Bioconjugation and Purification Process Development

DP Formulation & Process Development

Manufacturing

Payload-Linker Manufacturing

Targeting-vehicle Manufacturing

DS Manufacturing

DP Manufacturing

Analytical Development and QC

Analytical Method Development & Validation

Release Testing

Stability Study

Registration Services

CMC Filing Dossier

Supporting and Communication During Filing Process

Conjugates
  • Antibody-Drug Conjugate svgAntibody-Drug Conjugate svg1ADC
    Antibody-Drug Conjugate
  • AOC svgAOC svg1AOC
  • PDC svgPDC svg1PDC
  • PRC svgPRC svg1PRC
  • SMDC svgSMDC svg1SMDC
Targeting-vehicle

Antibody

Peptide

Small Molecule

Linker

Cys (-SH): S-S, Maleimide Group (mc, mcc, etc.)

Lys (-NH2): Activated Acid(CO-OSu, etc.)

Short Peptide (VC, GFGG, etc.)

PEG

Click Chemistry

pH-Sensitivity (HN-CH2-O-, C+N-NH=CO-, Hydrazine, Carbonate)

Multi Branches

Payload

Cytotoxic Drugs

Oligonucleotides

Radionuclides

Fluorescers

Early Stage Development

mg ~ g Scale Library

Developability Assessment

Process Development

Payload-Linker Process Development

Targeting-vehicle Process Development

Bioconjugation and Purification Process Development

DP Formulation & Process Development

Manufacturing

Payload-Linker Manufacturing

Targeting-vehicle Manufacturing

DS Manufacturing

DP Manufacturing

Analytical Development and QC

Analytical Method Development & Validation

Release Testing

Stability Study

Registration Services

CMC Filing Dossier

Supporting and Communication During Filing Process

Case Studies

More

Optimization of Synthetic Process and Metal-Chelation Impurity Control Strategy for Complex Peptide-based RDCs

It fully demonstrates the strength of Porton's one-stop RDC service platform, excellent project management capabilities, and efficient production and operation.

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The Perfect Integration of Immobilized Enzymes and Flow Chemistry: A Powerful Booster for the Commercialization of Biocatalysis Technology

Adhering to Porton’s core value of “Pursuing Excellence”, Porton biocatalysis team has designated "enzyme immobilization technology and its industrialization" as a core strategic technology.

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Process Simulation Platform: Enabling Process Development and Scale-up of Active Pharmaceutical Ingredients

Porton Crystallization team has the capability to perform process simulation of unit operations, including solvent swap, crystallization, filtration and drying.

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Process Chemistry

Optimizing Process Chemistry for Enhanced Pharmaceutical Manufacturing

Process Chemistry Optimization | Pharma Manufacturing

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Preparative Chromatography

Expert Q&A: How to Efficiently Apply Preparative Chromatography in Drug Research

How to Efficiently Apply Preparative Chromatography in Drug Research

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Biocatalysis for Sustainable APIs

Biocatalysis: A Powerful and Possible Greener Tool for Chemists in the Pharmaceutical Industry

End-to-end Enzyme Solutions Efficient Screening & process Development Comprehensive Quality Control Extensive Successful Applications Cases Technological Innovation Enabled Cost Savings

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Virtual screening

Expert Q&A: Molecular Simulation and Data Science Support of Porton

Explore virtual screening duration, differences from property optimization, and crystal structure requirements for impurity rejection calculations.

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Solid Form

Selecting the Right Solid Form-Faster, Smarter, Better

At Porton J-Star, we employ an integrated approach to identify and select the most suitable solid form for development (Figure 2). We conduct effective screen and rigorous assessments for polymorphs, salts, cocrystals, as well as amorphous solid dispersions, by applying our comprehensive expertise and experience.

More

Challenges and Advances in CMC Process Development of BsADCs

Antibody drug conjugates (ADCs) have seen significant breakthroughs and reached numerous milestones since 2000 when the first ADC was approved by the FDA and have shown great promise for the treatment of cancer. First generation ADCs were designed to use the affinity of an antibody towards a specific cellular target to bring the cytotoxic payload to the tumor, for example. However, some level of off-target toxicity was often seen with many ADCs because other cellular interactions could occur prior to the payload physically reaching its intended target or the payload could cleave off. These events could lead to unintended death of non-cancerous cells.

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Preformulation Strategy- Inception to Completion

Drug discovery is an exceedingly complex process. Discovering a new chemical entity is in itself a huge accomplishment, which is often possible only after almost two decades of hard experimental work as well as advanced simulation efforts. Therefore, the next stage of the process, determination of toxicity becomes even more crucial as most new chemical entities (NCE) are disqualified if the NCE shows a potential toxic effect, despite any possible therapeutic effect.

More

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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Molecular Modeling and Data Science for De-risking and Cost- saving of Pharmaceutical Development

Molecular Modeling and Data Science for De-risking and Cost- saving of Pharmaceutical Development

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