Clinical Development Services
Kilo-Scale Manufacturing for Clinical Advancement
Precision medicine and accelerated development timelines demand flexible, GMP-compliant manufacturing platforms that effectively bridge discovery and clinical supply. The ISO 8 Kilo Facility at PI Health Sciences, located in Lodi, is purpose-built to support route scouting, kilo-scale GMP production, and IND-enabling batches within a controlled and segregated environment designed for complex New Chemical Entities. This infrastructure enables sponsors to transition confidently from laboratory-scale chemistry to clinical-stage manufacturing without compromising quality, control, or speed.
Designed to the highest technological and operational standards, the facility integrates directly with our R&D laboratories, 250 L pilot plant, and 230 KL manufacturing infrastructure. This end-to-end connectivity ensures seamless technology transfer, structured scale-up, and efficient mid-scale validation as development programs progress. The integrated model minimizes discontinuity between stages and supports long-term supply continuity as molecules advance through clinical milestones.
By replicating commercial manufacturing parameters at the kilo scale, the ISO 8 suite functions as a scaled digital twin of full production. This approach enables early identification of process risks, operational bottlenecks, and scale-dependent variables before they impact timelines. As a result, programs benefit from strengthened process robustness, improved validation readiness, and enhanced regulatory confidence ahead of clinical progression.
The PI Advantage: Predictability, Agility & Quality
Our kilo-scale suite is a “Digital Twin” of our full-scale operations. By replicating commercial manufacturing early, we identify process challenges before they become bottlenecks.
Capabilities
Kilo-Scale GMP Processing
Seven independent walk-in hoods with two dedicated HVAC systems ensure maximum segregation and ISO 8 compliance. The automated reactor suite features a 50 L Hastelloy C22 reactor for corrosive/high-pressure reactions, a 140 L stainless steel reactor, and glass reactors (5 L, 10 L, 20 L, 50 L), all with real-time monitoring for precise control and reproducibility in complex NCE development.
Isolation & Drying
Integrated downstream processing includes a DN30 Agitated Nutsche Filter Dryer for controlled solid-liquid separation, a stainless steel vertical-axis centrifuge for efficient isolation, and a 100 L static dryer for precise moisture control. These systems ensure consistent solid handling and reproducible GMP-compliant processing.
Particle Engineering & Finishing
Milling and micronization capabilities enable targeted particle size distribution to support bioavailability and formulation objectives. A dedicated clean room finishing suite with independent HVAC ensures controlled final processing and product purity prior to clinical supply.
Route Scouting & Process Safety
Automated reactor monitoring enables early thermal risk identification, including exothermic and scale up hazards. Structured solvent optimization advances discovery chemistry toward commercially viable, sustainable options. Kilo scale parameter mapping ensures smooth transfer to pilot and full scale manufacturing.
End-to-End Scale Integration
The ISO 8 Kilo Facility operates as a connected bridge between R&D laboratories, the 250 L pilot plant, and 230 KL commercial manufacturing. This integrated infrastructure enables smooth tech transfer, mid-scale validation, and long-term manufacturing continuity as programs advance from preclinical to clinical stages.
Controlled Multi-Product GMP Environment
Dual HVAC systems and independent walk-in hoods provide physical segregation and contamination control within a multi-use facility. High-frequency air changes, controlled workflows, and ISO 8 compliance support parallel program execution while maintaining regulatory-grade quality standards.
Frequently asked questions
We’re here to help with any questions you have about our plans, supported features, and how our model works.
What batch size range does the ISO 8 Kilo Facility support?
The facility supports batch sizes from approximately 1 kg to 15 kg, serving as a structured bridge to our 250 L pilot plant for further scale-up.
Can corrosive and high-pressure chemistries be handled?
The 50 L Hastelloy C22 automated reactor is specifically designed for corrosive reagents and high-pressure conditions.
How is cross-contamination prevented?
Seven independent walk-in hoods and two dedicated HVAC systems ensure segregation and ISO 8 compliance.
How does the facility accelerate IND-enabling development?
By replicating commercial-scale parameters early, we identify scale-related risks and streamline validation cycles.
How is the Kilo Facility integrated with broader manufacturing?
The ISO 8 suite connects directly with R&D labs, the 250 L pilot plant, and 230 KL commercial manufacturing to ensure seamless development continuity.
Contact Us
Connect with PI Health Sciences to explore how our integrated in silico and in vitro immunogenicity assessment capabilities can support your development programs, from early epitope risk prediction and impurity profiling to PBMC-based functional validation and regulatory-aligned immunogenicity risk mitigation strategies.