ADC CDMO & Bioconjugate CDMO Services

Elise Biopharma — The End-to-End ADC CDMO & Bioconjugate CDMO

One partner. All modalities. From discovery-grade conjugation through IND, PPQ, and commercial release.
Elise Biopharma is the benchmark for complex conjugates—the ADC CDMO and Bioconjugate CDMO that sponsors call when the chemistry is unforgiving, the payload is ultra-potent, and the analytics must hold up in front of the toughest regulators. We deliver a truly complete antibody–drug conjugate (ADC) and protein/peptide/oligo bioconjugation platform under one roof: antibody or binder supply (CHO/HEK/VHH), linker–payload synthesis and qualification (MMAE/MMAF, DM1/DM4, PBDs, duocarmycins, topoisomerase inhibitors, radiochemistry chelators), site-specific or stochastic conjugation (Sortase A, TGase, aldehyde-tag/oxime, UAA, glycan remodeling, re-bridging), polishing and formulation (hydrophobicity management, PEG/spacers, liquid or lyo DP), OEB-5 HPAPI containment in barrier isolators, phase-appropriate orthogonal analytics (HIC/native-MS DAR, peptide-mapping site localization, free-drug/linker by UPLC-MS, stability), and global regulatory support from IND/IMPD through PPQ and commercial CPV.

If you’re searching for the best ADC CDMO or best Bioconjugate CDMO, this page shows how Elise sets the standard: scalable process design that preserves potency and PK, meticulous impurity control with validated purge factors and residuals testing, and powerful characterization that de-risks filings and accelerates approvals. Beyond classic cytotoxic ADCs, we also execute antibody–oligonucleotide conjugates (AOCs), peptide/protein conjugates, polymer/PEGylated constructs, and radioconjugate cold-chemistry—each supported by QbD, PAT, and digital-twin models that compress timelines without compromising compliance. This is end-to-end antibody-drug conjugate manufacturing done right, by the team engineered to be the best in the world.

Why ADCs & Bioconjugates Need a Specialist CDMO

Conjugates live at the intersection of biologics, small molecules, and aseptic operations. Success hinges on solving three hard problems at once:

Chemistry meets biology. Linker–payload stability, hydrophobicity management, and solvent/aqueous compatibility must be balanced against antibody structure, potency, and immunology (Fc-effector function, binding kinetics).
Extreme containment and precision. Modern payloads are HPAPIs (auristatins, maytansinoids, PBDs, duocarmycins, camptothecin derivatives). Achieving OEB-5 controls while maintaining reproducibility requires isolators, barrier tech, validated cleaning, and in-process controls tuned to nanogram levels.
Analytics that actually de-risk. Regulators expect orthogonal DAR (drug-to-antibody ratio) methods, conjugation-site mapping, free drug/linker quantification, aggregation/fragmentation profiling, and long-term stability models—plus comparability across process and site changes.

Elise Biopharma built its ADC & bioconjugation services to solve precisely these issues—efficiently, safely, and at scale.

What We Make

Antibody–Drug Conjugates (ADCs) for oncology and beyond (cytotoxic, immunomodulatory, and emerging non-cytotoxic payloads)
Protein and peptide conjugates (enzymes, cytokines, albumin, VHH/nanobodies, Fc-fusions)
Antibody–Oligonucleotide Conjugates (AOCs) and siRNA/ASO conjugates
Radioconjugates / radioimmunoconjugates (chemistry and cold-label development; hot work available via qualified partners)
Glyco- and polymer-conjugates (PEGylation, polysaccharide, HSA)
Dual-payload and next-gen formats (bispecific-ADC, immune-stimulatory conjugates)

If you’re evaluating platforms, our team can host a 60-minute feasibility review to align your target product profile (TPP), CQAs, and clinical path with phase-appropriate manufacturing at Elise Biopharma.

The Elise ADC & Bioconjugation Platform (End-to-End)

Antibody / Binder Supply & Qualification

Sources: Your CHO program (tech-transfer) or our rapid-expression toolbox (CHO, HEK; VHH/Nb in Pichia).
Pre-conjugation conditioning: Buffer exchange, controlled partial reduction, oxidation state control, thiol profiling, endotoxin reduction to parenteral specs, bioburden controls.
Characterization: Intact mass, peptide mapping, glycan profiling, SEC-MALS, CE-SDS, SPR/Biacore binding, Fc-effector function panels.

Linker–Payload Sourcing, Synthesis & Release

Payload classes: MMAE/MMAF (auristatins), DM1/DM4 (maytansinoids), PBD dimers, duocarmycins, camptothecin/topoisomerase inhibitors, immunostimulatory TLR ligands, non-cytotoxic payloads (e.g., PROTAC-like, degrader conjugates).
Linker systems: Cleavable (vc-PABC, hydrazone, disulfide), non-cleavable (thioether), hydrophilic linkers (PEG/spacers) for hydrophobicity management.
Synthesis & QC: Route scouting, impurity fate mapping, residual metal/solvent testing, polymorph control (where applicable), and stability indicating methods.
Chain of custody & security: GMP storage, vaulting for cytotoxics, serialized inventory, and dual-person verification protocols.

Conjugation Chemistries

Cysteine-based (maleimide / bromoacetamide): Controlled partial reduction of interchain disulfides; retro-Michael mitigation via succinimide ring hydrolysis tuning; re-oxidation strategies to maintain Fc integrity.
Lysine-based (NHS esters): Stochastic labeling for early discovery or when DAR distribution can tolerate heterogeneity.
Disulfide re-bridging: Dibromomaleimides, pyridazinediones for stable, site-defined bridges.
Enzymatic site-specific conjugation: Sortase A, microbial transglutaminase, GlyCLICK/FGE-aldehyde tag (oxime ligation), UAA strategies (p-azidophenylalanine).
Click chemistry: SPAAC (DBCO–azide), CuAAC (with copper residual control), tetrazine–TCO iEDDA for ultra-fast ligations.
Tyrosine/tryptophan selective approaches for niche payloads; carbohydrate-directed glycan conjugation.
AOCs & oligo conjugation: Heterobifunctional linkers for ASO/siRNA; end-capping QC, nuclease stability models.

Purification & Polishing

Hydrophobicity-tuned polishing to retain target DAR while removing over-conjugated species.
SEC for aggregate removal, HIC guided enrichment, AEX/CEX where charge windows control variant populations.
Free payload/linker scavenging (solid-phase resins, liquid–liquid extraction) with ultra-trace release methods.
Solvent management: In-process solvent limits with validated purge factors; DoE-driven buffer/solvent interactions to minimize aggregation.

Formulation, Fill & Presentation

Formulation screens: Ionic strength, pH, excipient libraries (trehalose, histidine, arginine, surfactants), chelator controls (maleimide stability), oxidative stress screens.
Presentations: Liquid vials or lyophilized cakes for DP; ready-to-dilute concentrates for hospital pharmacy workflows; light-sensitive packaging design.
Container/closure integrity (CCI) and extractables/leachables programs aligned to dosage form and storage conditions.

Phase-Appropriate Analytics (Orthogonal, Regulatory-Ready)

Why this matters for ADCs & bioconjugates.
In conjugates, the product is not just an antibody plus a small molecule—it’s a distribution of species (DAR micro-populations, conjugation sites, variants), each with its own PK/PD and safety profile. Phase-appropriate, orthogonal analytics are the fastest way to turn complexity into regulatory confidence. As a top-tier ADC CDMO / Bioconjugate CDMO, Elise Biopharma builds an analytical backbone that scales from discovery screens to commercial release without re-learning the molecule at each phase.

How we structure the analytical lifecycle.

Discovery / Feasibility: Rapid-turn ID & heterogeneity reads (intact/native MS, HIC for DAR), stress-screen snap-shots, and binding checks to guide chemistry selection (cleavable vs non-cleavable, spacer hydrophilicity, re-bridging feasibility).
GLP tox / IND: Qualified methods with orthogonal confirmatory assays; stability-indicating methods locked; draft specs and trendability established.
Phase II/III: Full method validation per ICH Q2(R2); process characterization studies define CPP→CQA linkages; comparability packages ready for scale/site changes.
Commercial: Validated release/stability panels, CPV dashboards, and lifecycle management aligned to ICH Q12/Q14.

DAR & distribution (measured the right way).

Primary: HIC with calibrated response factors to quantify average DAR and species distribution (e.g., 0–8).
Orthogonal: Native MS (deconvolution of charge envelopes) and intact mass; UV/Vis A280/λpayload ratioing as a qualified secondary.
Middle-down options: IdeS-based subunit LC-MS for domain-level DAR confirmation when needed.
Controls we apply: DAR drift monitoring across holds/temperature excursions; linker-dependent retro-Michael tracking; hydrophobicity-management (PEG/spacer) impact on DAR retention.

Conjugation site mapping & higher-order checks.

Peptide mapping LC–MS/MS to localize conjugation chemistry (Cys, Lys, glycan-directed, enzymatic tags), verify re-bridged disulfides, and detect micro-heterogeneity.
Disulfide pattern verification (reduced/non-reduced CE-SDS + peptide mapping) to ensure Fc integrity after partial reduction.
Optional deep-dive tools for tough cases: middle-down MS, limited HDX-MS screens for solvent/aggregation sensitivity, and DSC to map thermal liabilities.

Purity & variants (see what matters, not just what’s visible).

Aggregates & fragments: SEC-MALS (quant + MW), CE-SDS (reduced/non-reduced) for clip/fragment tracking.
Charge variants: icIEF/cIEF to understand conjugation-driven charge shifts and excipient effects.
Microvariants: RP/UHPLC methods tuned to capture payload-induced hydrophobic variants; orthogonal confirmation by MS where value-adding.

Free drug/linker & reagent residuals (ultra-trace where it counts).

UPLC-MS with SPE or LLE cleanup; isotope-dilution where appropriate; LOQs in low ng/mL regime with demonstrated recoveries and matrix ruggedness.
Residuals panel: Solvents (GC), metals (ICP-MS, with specific attention to residual copper after click chemistry), reducing agents (e.g., TCEP), scavenger carryover, and process reagents.
Purge maps embedded in CMC to defend impurity fate and safety margins.

Potency & binding (mechanism-linked, phase-appropriate).

Binding: ELISA, SPR/BLI kinetics against antigen; Fc-effector panels (ADCC/CDC/ADCP) if MOA requires.
Potency: Cell-based cytotoxicity assays (2D and, where justified, 3D spheroids) with appropriate controls; for AOCs/oligo conjugates, uptake and target-knockdown assays.
Bridging strategy: Early mechanistic assays that can be validated later, minimizing rework between phases.

Safety & quality (release-critical).

Endotoxin: rFC or LAL per jurisdiction; bioburden with targeted action limits.
Residual HCP/DNA when we supply the antibody DS; particulates by MFI/RMM; osmolality, pH, viscosity as needed for DP.
Container/closure integrity (CCI) and extractables/leachables programs fitted to DP and shelf-life goals.

Stability (what fails, when, and why).

ICH-aligned long-term & accelerated programs, plus photostability (Q1B), freeze–thaw, agitation, and oxidative stress.
Failure-mode mapping: Retro-Michael deconjugation, linker hydrolysis, payload oxidation/isomerization, aggregate growth kinetics.
Shipping simulation (thermal profiles, vibration) and in-use stability (diluent/IV bag) for hospital workflows.

Bottom line: you get an orthogonality matrix that regulators can trust and a release panel that scales—so your ADC manufacturing stays fast, compliant, and predictable.

HPAPI Containment & EHS

Our principle: zero compromise on safety, zero friction on productivity.
Nearly every modern ADC involves HPAPIs. Elise operates OEB-5–capable suites designed specifically for cytotoxic payloads and conjugation solvents—so you never trade containment for cycle time.

Facility & engineering controls you can trust.

Barrier isolators with dedicated HVAC, pressure-cascade differentials, interlocked pass-throughs, and RTPs (rapid transfer ports) to move materials without breaking containment.
Single-use flow paths and closed transfers minimize cleaning burden and cross-contamination risk.
Segregated campaigns with dedicated waste streams and storage; restricted tools/consumables per suite.

Verification & ongoing assurance.

SMEPAC-style exposure assessments using qualified surrogates; acceptance criteria locked into change-control.
Routine wipe sampling & personal monitoring to trend operator exposure; glove-integrity and isolator leak-tests on defined intervals.
Changeover acceptance with swab limits traceable to LOQ studies (sub-ng/cm² where needed).

People & material flows that actually work.

Unidirectional flows from clean to potent zones; segregated gowning (primary/secondary) with barcode traceability.
Double-person verification for payload receipt, weighing, charge-in, and waste reconciliation.
Material entry via staged de-bagging and surface decontamination; dedicated carts and color-coded consumables.

Cleaning validation & deactivation.

Worst-case residue studies by surface/material class; validated deactivation chemistries for common payload/linker families.
Analytical sensitivity proven for difficult-to-clean geometries; campaign-end and periodic deep-clean protocols.

Waste, spill & environmental controls.

Cytotoxic waste segregation (solids, sharps, liquids) with documented neutralization; effluent collection and controlled discharge.
Spill response SOPs with trained teams, PPE staging, and post-event verification sampling.
Environmental monitoring tailored to potent chemistries (air/surface), trended in the QMS.

Net effect: OEB-5 operations that pass audits smoothly and allow your ADC program to scale without “containment surprises.”

Digital Twins, PAT & Data Integrity

Speed with control: how we make complex processes behave.
Conjugation is a multi-factor, solvent-sensitive reaction network. Elise uses digital twins and PAT to predict and control outcomes (DAR, aggregation, free drug) lot-after-lot—shrinking iteration cycles while strengthening your regulatory story.

Process digital twin (from partial reduction to polish).

Hybrid models combine mechanistic understanding (thiol generation, Michael addition kinetics, quench efficiency) with MVDA/ML trained on campaign data.
What we predict: DAR distribution, hydrophobicity shifts, aggregation risk, solvent/buffer compatibility, and polishing yield.
Golden-batch fingerprints: Real-time comparisons to detect drift early; auto-alerts tied to eBR.

Inline/atline PAT (see the reaction, not just the result).

Inline UV/Vis & RI to monitor conjugation kinetics and quench endpoints; atline UPLC micro-samples to verify free drug and linker consumption.
Soft sensors infer hard-to-measure states (e.g., effective reducing equivalents, payload:antibody ratio in solution) from correlated signals.
Chromatography RTD studies for HIC/SEC steps to protect the DAR window and minimize over-polish losses.

QbD control strategy & CPV (built for late phase).

CPP→CQA maps: temperature, pH, solvent %, reduction time, quench profile, load density, and residence times linked to DAR, aggregation, potency, and residuals.
Design space & edge-of-failure runs pre-define safe operating windows; control loops implemented in MES/PLC recipes.
CPV dashboards (capability indices, SPC) support continued process verification and feed RTRT discussions where justified.

Data integrity & GxP automation (ALCOA+).

21 CFR Part 11 / Annex 11 compliant systems: validated LIMS, MES/eBR/EBR, and secure e-signatures.
Audit trails protected and reviewed; role-based access; automated data backups with integrity checks.
Cyber & segregation: GxP networks segmented; vendor access control; routine disaster-recovery drills.

Outcome: a predictable, model-informed ADC manufacturing process that regulators understand and reviewers reward with faster, cleaner approvals.

Regulatory & CMC (Phase-Specific)

Our philosophy: write CMC the way reviewers want to read it—risk-based, orthogonal, and mapped to guidance. As a global ADC CDMO / Bioconjugate CDMO, Elise anchors conjugate programs to the relevant ICH stack (Q2(R2), Q5E, Q6B, Q8–Q12, Q13, Q14) and regional expectations (FDA, EMA, PMDA, Health Canada).

Discovery → GLP tox (fast learning, right documentation).

“Tox-representative” processes locked early (same linker system, reduction/quench strategy, and polishing train you intend to carry forward).
2–3 GLP lots with comparability-ready analytics (DAR, site mapping, free drug, aggregation).
Draft specs and stability-indicating methods identified; preliminary risk register covering payload hazards, purge, and solvent compatibility.

IND/IMPD (your first major quality story).

Module 3 (CTD) or IMPD Quality authored with a clear control strategy: CQAs, CPPs, design space rationale, and orthogonality matrix.
Impurity fate & purge assessments with quantified margins; free payload/linker and residuals methods documented with LOQs and recoveries.
Analytical qualification complete; validation staged to Phase II plan; comparability protocol in place for expected changes (scale, site, raw-material source).

Phase II/III (prove robustness; prepare PPQ).

Process characterization (QbD): DoE matrices across reduction, conjugation, quench, and polishing; RTD mapping for chromatography.
PPQ plan and acceptance criteria; hold-time/in-process stability, shipping and temperature-excursion validation.
Spec refinement with clinical knowledge (exposure–response tied to DAR distribution and aggregation limits).
Method validation (ICH Q2(R2)) complete for release/stability; lifecycle and transfer protocols approved.

BLA/MAA (no loose ends).

PV reports & CPV: evidence that the design space holds in routine; capability indices and trend analysis.
Post-approval change playbooks (ICH Q12) defining pre-agreed categories, data, and timelines.
Globalization: regional annexes (EU QP expectations, Japan bridging), labeling/shelf-life harmonization, serialization/traceability for DP when applicable.

Global pathways & special cases.

FDA, EMA, PMDA, Health Canada alignment with prior-advice where helpful; readiness for Type C/scientific advice meetings.
QP-release via partners when EU importation is needed; dual-region supply strategies to strengthen resilience.
Radioconjugate routes: cold-chemistry CMC authored in sync with isotope-handling partners for a single cohesive story.

Your advantage: fewer CMC questions, faster reviews, and a control strategy that survives real-world changes without costly rework.

Scales, Timelines & Suites

Bench & discovery: Milligram → multi-gram feasibility and SAR exploration with rapid analytics (1–3 weeks per iteration typical for familiar chemistries).
GLP tox & Phase I/II: 10–200 g per lot with validated containment; in-house aseptic DP or tech-transfer to dedicated fill–finish.
Late-phase & commercial: Hundreds of grams to kilogram-class batch sizes, campaignable with dual-suite strategy; PPQ-ready documentation and CPV onboarding.

We coordinate antibody DS availability, payload/linker lead times, and analytical method lifecycle to compress critical path without compromising compliance.

Conjugation Chemistries — At a Glance

Cleavable linkers: vc-PABC, hydrazones, disulfides (with tunable reduction potential).
Non-cleavable linkers: Thioether (maleimide), stable re-bridging variants.
Site-specific: Enzymatic (Sortase A, TGase), aldehyde-tag/oxime, UAA (pAzF), glycan remodeling (GlyCLICK).
Click & bioorthogonal: SPAAC (DBCO–azide), CuAAC (with residual copper control), tetrazine–TCO cycloaddition.
Re-bridging: Dibromomaleimide, pyridazinedione platforms.
AOC/oligo: Thiol–maleimide, copper-free click, heterobifunctional spacers for ASO/siRNA, end-labeling analytics.
Polymer & PEGylation: Linear/branched PEGs, PASylation-like approaches.
Radioconjugation (cold chemistry): Chelator installation (DOTA, DTPA, NOTA) with metal impurity control and ICP-MS verification.

Analytics That Win Audits

Regulators increasingly expect orthogonal proof of identity, purity, potency, and stability for conjugates. We qualify and validate methods in-house or with trusted partners:

Identity & heterogeneity: Intact/native MS, peptide mapping LC–MS/MS, glycan profiling.
DAR & species distribution: HIC (gold standard), native MS deconvolution, UV/Vis secondary.
Aggregation & fragments: SEC-MALS, CE-SDS (red/non-red), icIEF, DLS.
Function: Cell-based cytotoxicity, ELISA/SPR for binding, Fc functionality (ADCC/CDC/ADCP) as needed.
Impurities: Free drug/linker (UPLC-MS), residual solvents & metals (GC/ICP-MS), residual copper (click), residual TCEP/other reductants, extractables/leachables for DP.
Safety: Endotoxin (rFC or LAL), bioburden, particulates (MFI/RMM), HCP/DNA where applicable.
Stability: Real-time and accelerated, forced degradation pathway mapping (retro-Michael deconjugation, linker hydrolysis, oxidation).
For radioconjugates: Chelate integrity (HPLC), metal analysis (ICP-MS), radiochemical purity (via partner hot labs).

Facility & Containment Overview

Dedicated ADC/HPAPI suites with barrier isolators, negative pressure, and high-efficiency filtration.
Single-use flowpaths to reduce cleaning/turnover and mitigate cross-contamination.
Material & personnel segregation, unidirectional flows, and campaign-based scheduling.
Cleaning validation specific to cytotoxics with bespoke acceptance criteria and analytical sensitivity down to sub-ng/cm².
Environmental Health & Safety: Cytotoxic waste streams, validated deactivation procedures, and emergency response drills.

Development Path & Typical Deliverables

Discovery / Feasibility (non-GMP)

1–3 conjugation chemistry options screened with small-scale DoE.
Rapid analytics pack: identity, preliminary DAR, stability snapshot, potency screen.
Tech memo with risk register (hydrophobicity, aggregation, payload stability).

GLP Tox / IND-Enabling (GMP)

Scale-appropriate synthesis of linker–payload (GMP where required) and conjugation runs under GMP.
DS and/or DP with full CoA; methods qualified; stability program initiated.
IND/IMPD CMC module draft with control strategy and impurity fate maps.

Phase II/III

Process characterization (QbD): CPP/CQA maps, design space proposals, hold-time and shipping validation.
PPQ plan; comparability protocol for post-changes; secondary sourcing/risk mitigation.

Commercial

CPV dashboards; annual product review; lifecycle management (Q12); global supply resilience (dual region if desired).

Case Snapshots

Case 1 — Hydrophobicity Crisis Resolved: Sponsor’s vc-MMAE ADC aggregated post-conjugation at >10%. Our team introduced a short PEG spacer, adjusted quench chemistry to favor succinimide hydrolysis (retarding retro-Michael), and optimized polishing with HIC+SEC. Aggregates dropped below 1.5% with stable DAR 3.9–4.1 and improved shelf-life.
Case 2 — Free Drug at Release: Early process left trace free DM4 above spec. We implemented solid-phase scavenging plus a targeted liquid–liquid wash and validated a UPLC-MS method to <5 ng/mL. Batches cleared first-pass review with robust purge factors documented in the CMC.
Case 3 — Site-Specific Scale-Up: Sortase-based site-specific conjugation worked in discovery but stalled at 50 g. We re-engineered the feed strategy and enzyme recycling, cutting enzyme costs by 60% and improving yield 1.7×; the sponsor advanced to tox on schedule.

Why Elise Biopharma as Your ADC CDMO / Bioconjugate CDMO

1) End-to-end under one contract. Antibody expression to payload synthesis to conjugation, polishing, formulation, analytics, and regulatory—without hand-offs.
2) True HPAPI depth. OEB-5 isolators, SMEPAC-verified workflows, validated cleaning and cytotoxic waste handling.
3) Orthogonal analytics that stand up in audits. HIC/native-MS DAR, site mapping, impurity fate, stability, and potency—designed to satisfy FDA/EMA expectations.
4) Site-specific expertise. Enzymatic, glycan-directed, UAA, and re-bridging approaches when DAR uniformity and lot-to-lot reproducibility matter.
5) Digital & data-driven. QbD, PAT, and digital twins to shrink process variability and accelerate PPQ.
6) Global readiness. IND/IMPD authoring, PPQ planning, CPV, and QP-release via partners if required.

Representative Equipment & Tooling

Conjugation skids/reactors: Jacketed vessels (glass/stainless), micro- and meso-scale flow reactors for continuous conjugation feasibility.
Chromatography: HIC, SEC, AEX/CEX, mixed-mode; FPLC/UHPLC platforms with multicolumn options.
Formulation & F/F: Aseptic isolator fills, peristaltic/rotary piston pumps for low-shear transfers, lyo cycles for conjugates.
Analytics: UHPLC-MS (intact & peptide), SEC-MALS, CE-SDS, icIEF, DLS, MFI/RMM; ICP-MS for metals; GC for solvents; ELISA/SPR; cell-based potency suites.

Risk Management & Comparability

Design-space documentation early (even at tox) to future-proof post-change filings.
Comparability protocols pre-agreed to speed process/facility changes.
Secondary sourcing strategies for payloads/linkers with long lead times.
Shipping and hold-time validation to support global trials and launches.
Change control integrated with your QMS (or ours) for transparent governance.

Program Onboarding: What We Need to Start

Target Product Profile and intended indication(s)
Antibody details (sequence, glycoform goals, upstream expression data, existing analytics)
Payload–linker information (structures, impurities, prior conjugation data, safety class)
Quality target product profile (QTPP) and critical quality attributes (CQAs)
Desired scales and timelines (discovery, tox, Phase I–III, commercial)

No payload selected yet? We can start with a chemistry feasibility package to pick the optimal linker system and conjugation route before committing to GMP chemistry.

ADC Frequently Asked Questions

Q1: Do you support both stochastic and site-specific ADCs?
Yes. We run cysteine and lysine approaches for discovery and offer Sortase A, TGase, glycan and UAA-based strategies for site-specific programs that require narrow DAR distributions and consistent PK/PD.

Q2: Can you manufacture my antibody as well as conjugate it?
Absolutely. We can express and purify your mAb (or VHH/fragment) in CHO/HEK or tech-transfer your DS. We’ll implement pre-conjugation conditioning (buffer, oxidation state, endotoxin removal) to ensure conjugation consistency.

Q3: What batch sizes can you run for GLP tox and Phase I?
Typical tox/Phase I batches range from tens to hundreds of grams. We scale to kilogram-class for late-phase/commercial campaigns.

Q4: How do you control free payload and residuals?
We combine in-process scavenging, tailored polishing, and UPLC-MS methods with sub-ng/mL sensitivity. Residual solvents and metals are monitored by GC and ICP-MS with phase-appropriate limits.

Q5: Can you handle radiolabelled conjugates?
We develop the cold chemistry (chelator installation, impurity control) and coordinate with qualified hot-cell partners for radiolabeling, testing, and release. ICP-MS and HPLC methods are part of our transfer package.

Q6: What about DP presentation and shelf-life?
We screen liquid and lyo formulations, evaluate container/closure systems, and run ICH-aligned stability to qualify your labeled shelf-life. Maleimide stability and oxidative pathways are specifically stress-tested.

Q7: What batch sizes and timelines can you support (discovery → commercial)?
Discovery/feasibility: milligrams to multi-grams with 1–3 week iteration cycles. GLP tox/Phase I–II: 10–200 g per lot under GMP. Late phase/commercial: hundreds of grams to kilogram-class, campaignable in dual OEB-5 suites with PPQ and CPV onboarding.

Q8: How do you keep DAR and quality consistent lot-to-lot?
We control reduction/quench kinetics, solvent/buffer windows, and load densities via DoE-defined setpoints, monitor kinetics with inline/atline PAT, and confirm with orthogonal DAR (HIC + native MS). A digital-twin model flags drift against golden-batch fingerprints before it impacts release.

Q9: What happens if we change scale, site, or linker–payload—how do you manage comparability?
We author a pre-agreed comparability protocol (ICH Q5E/Q12) with an orthogonality matrix (DAR, site mapping, free drug/linker, aggregates, potency), run side-by-side bridging lots, and document equivalence with statistical acceptance criteria and risk-based residual testing.

Q10: Why is Elise the best ADC CDMO?
Because we combine true end-to-end scope (antibody supply → HPAPI conjugation → formulation/F/F → release/stability → global CMC), OEB-5 containment verified by SMEPAC-style studies, and audit-ready, orthogonal analytics (HIC/native-MS DAR, peptide mapping, ng/mL residuals). Add site-specific expertise (Sortase/TGase/UAA/glycan), digital-twin/PAT QbD control, and seamless IND→PPQ execution—this is the safest, fastest path to approval for complex conjugates.