Welcome to Devens

Welcome to Devens. Groundbreaking Ceremony. June 18, 2025.

Site Overview.

3. Devens Site Overview. 214 employees Built in 2000 by Pharm-Eco, acquired by Johnson Matthey in 2001. 160,000 Sq Ft. total site area $2 million HPAPI expansion in 2021. $30 million ADC facility investment in 2024. FDA Inspected PMDA Accredited Extensive development and GMP labs, clinical and commercial kilo labs, and multi-purpose small-scale plants. 3-suite commercial pilot plant.

4. The Expansion by the Numbers. Expected to generate 24 new jobs in $30 million construction project 1 process development laboratory and 2 cGMP suites to handle potent compounds, ADC linker-payloads, and other complex molecules. . Manufacturing, R&D, and QA/QC The 9,000 square foot expansion will build upon the site's existing development and manufacturing capabilities..

5. The significant expansion of our antibody-drug conjugate (ADC) and highly potent compound development and manufacturing capabilities at Devens will build upon the site’s existing development and manufacturing capabilities to address the growing demand for strong US-based capacity for ADCs and other potent small molecules.

6. The contribution of the expansion to the pharma and biotech industries will address the need for a US-supply of life-saving therapies for patients not only in the US but all over the world.

7. The expansion will open more employment opportunities for local residents with the creation of new jobs.

8. These facilities, equipped to manage high-potency compounds, ADC linker-payloads, and other complex molecules, will feature: Dedicated air handling systems Airlocks for clean-in-place operations Isolator technology A comprehensive range of processing capabilities, including synthesis reactors, chromatography, thin film evaporators, and lyophilization.

[image]. Building 3 Pilot Plant. 9. Devens Site Map.

10. Extensive development and lab-scale manufacture​ (Devens) Dedicated clinical and commercial kilo labs Highly potent APIs up to SafeBridge® category 4 5 L - 100 L jacketed reactors Temperatures from -78°C to 150 °C 40 L and 80 L glass-lined steel and 20 L Hastelloy reactors Pressures up to 100 psi Diafiltration and reverse osmosis capabilities.

11. Compliant with local, state and federal regulations for hazardous waste, for Large Quantity Generators (LQG). Air and wastewater permits. Environmental monitoring and water testing. Active Sustainability Committee involved in ESG's initiatives. Regularly inspected and audited by relevant governing agencies. In-process control, intermediate release, final product, data review, and stability testing. Basis for controlling production, incoming raw materials and manufacturing of controlled drugs. Process Safety Management of over 10,000 lbs of flammables and Hydrogenation in kilo and production area. Potent Compound Management in lab, kilo, and production areas (CB5 in lab and kilo, CB4 in production)..

Products & Services.

13. Product Categories. Highly Potent APIs Development and manufacturing of cytotoxic compounds up to SafeBridge® category 4 Antibody-Drug Conjugates (ADCs) Development and manufacturing of linkers and payloads for novel drug conjugates PEGs and Lipids Custom synthesis of PEG and lipid drug linkers and modifiers Crystallization of flexible molecules containing PEG moieties Targeted Protein Degraders (TPDs) Development and manufacture of PROTACS Crystallization of flexible molecules Small Molecule APIs Development and manufacturing of specialty APIs and controlled substances.

14. CDMO Service Offerings. Chemical Process Development (PRD) Chromatography, Purification & Separations Chemical Process Design – Preclinical to commercial Expedited Development – Computer assisted process development, DoE, catalytic screening, modelling, & scale-up Process Characterization – FTIR, Raman, FBRM, EasyMax & OptiMax reaction platforms Process Safety Assessments – Thermal hazards evals, DSC, RC1, AKTS Quality by Design (QbD) – Reaction and crystallization design Control Strategy Development – Risk assessments, material attributes, in-process controls, phase appropriate specs Technology Transfer – Throughout network Process Validation – CPD, PC, PPQ, CPV Multiple preparative chromatography solutions at all scales from development to production Cutting-edge instrumentation and techniques to purify an extensive range of compounds in line with GMP standards Amorphous solids, lipids, drug polymer conjugates, ADC linkers & payloads, peptide & nucleoside analogs Purification of HPAPIs and controlled substances Method Development Chiral Separation Impurity Isolation Post-separation processing – Thin Film Evaporation (TFE) Spray Drying Analytical Method Development (ARD) Phase-appropriate Method development, qualification, validation, and transfer Phase-appropriate Specification and Justification setting Analytical quality by design and lifecycle management ICH release/stability including photostability; reference material program ICH Q3D elemental impurity risk assessments pGTI and Nitrosamine testing and risk assessments Characterization of API and precursors HPAPI testing.

15. CDMO Service Offerings. Solid Form & Particle Engineering Form Selection – Salt, Polymorph, Co-crystal, Solid-Form Characterization, PhysChem Analysis, Form Diagram & Developability Amorphous Dispersion – Screening & Selection, Spray Drying, Co-precipitation Particle Engineering – Crystallization Development, Spray Drying, Modification of Particle Size & Morphology Secondary Processing – Dry Milling, Jet Milling, Wet Milling Pre-formulation – Evaluation of Formulated Product, Enabling Formulation, Comparison of Performance In-vitro, Stability & Robustness Testing Project Management Dedicated global team provides reliable control of project Cross-functional project team members ensure required resources are assigned and leveraged Single point of contact provides personalized approach to communication. Timeline management, project planning, and budget control Post-project client surveys and project close-out reports Risk management In-house testing and release of API Quality Control and Microbiology.

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