From Concept → Development → Scalable GMP Manufacturing
We focus on development and scale-up of oligonucleotide, peptide, and ADC bioconjugates. Our role is to build GMP-ready, manufacturable processes under GLP and ISO 13485 that can be smoothly transferred into your preferred GMP manufacturing network.
Bio-Synthesis provides dedicated bioconjugation process development for programs transitioning from discovery toward regulated manufacturing. Our expertise spans oligonucleotide, peptide, and ADC conjugates, applying structured development principles that embed manufacturability, scalability, and analytical readiness from the very beginning.
Whether you’re evaluating a novel conjugation pathway, optimizing reaction conditions, or preparing for GMP technology transfer, we focus on delivering a controlled, reproducible, and scale-appropriate bioconjugation process tailored to your modality and program needs.
A clear, staged path from early feasibility to pilot scale and GMP-ready process documentation.
Early input on conjugation chemistry, linker options and manufacturability risk so you start with a realistic plan.
Build, optimize and characterize robust bioconjugation processes with integrated analytics and impurity control.
Translate lab-scale processes to pilot scale and deliver a GMP-ready package for your chosen manufacturing partner.
Our bioconjugation development platform is built for oligonucleotides, peptides and antibody–drug conjugates (ADCs), with process engineering and analytics tuned to each modality’s unique challenges.
Development and scale-up of oligonucleotide conjugates for delivery, targeting and diagnostics.
Site-aware conjugation of functional and targeting peptides, optimized for potency, solubility and manufacturability.
Early-stage ADC and complex protein–drug conjugation processes built for transfer into high-potency GMP facilities.
Our workflow is built for high transparency and predictable decision points. Each phase has defined deliverables, so you always know where your bioconjugation program stands and what’s required to move ahead.
We evaluate your target, carrier, payload and intended use to define a realistic conjugation strategy.
We build a robust base process, focusing on reproducibility and control of critical quality attributes.
Using data-driven tools (including DoE where appropriate), we tighten process ranges and improve performance.
We translate the optimized process to larger equipment, generating material for preclinical or diagnostic use and validating scale-dependent behavior.
We prepare a complete, GMP-ready package so your manufacturing partner can implement the process efficiently.
Every project is structured so that you leave with more than just data – you receive a GMP-ready process asset.
We do not operate as a GMP manufacturing site. Instead, our core strength is delivering high-quality, GMP-ready bioconjugation processes that slot efficiently into your existing CMO/CDMO network.
Our development and scale-up activities are executed within a quality framework built on GLP principles and ISO 13485-compliant systems, making it easier to integrate our work into regulated pipelines.
We combine deep bioconjugation chemistry with process engineering discipline to create scalable, manufacturable solutions across oligo, peptide and ADC programs.
Experience across oligo, peptide and ADC bioconjugates, enabling consistent decision-making and platform reuse.
Every experiment is designed with later stages in mind – equipment, materials and operations that can scale.
Clear, science-driven communication with shared data, regular checkpoints and decision gates.
We deliver processes and documentation purpose-built for handoff to your GMP manufacturing partners.
Share your target modality (oligo, peptide or ADC), project stage and intended use. Our team will review your requirements and propose a tailored development and scale-up plan.
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Trusted by biotech leaders worldwide for over 40+ years of delivering high quality, fast and scalable synthetic biology solutions.