Advanced Process Development (PD) Lab

Mission

The mission of CIADM Advanced Process Development Laboratories is to be the supplier of choice for high-quality product development and manufacturing services utilizing bacterial and yeast fermentation as well as mammalian cell culture. CIADM maintains and operates a process development and cGMP manufacturing facility with highly skilled staff to produce recombinant proteins, monoclonal antibodies, viral materials, bacteriophages, stem cell materials, and DNA/RNA molecules to support preclinical studies through phase I human clinical trials.

CIADM Advanced Process Development Laboratories provides contract manufacturing services to academic research institutions and biotechnology/pharmaceutical companies engaged in preclinical and clinical manufacturing. We provide a complete package from process development through appropriately scaled manufacturing, purification, bulk packaging, and filling. Our capabilities include a range of analytical services and regulatory/compliance support. We will customize programs based on the client’s requirements and regulatory expectations.

Process Development and Scale-up

The optimal performance of manufacturing systems relies on well-planned process development. Our team assists clients in facilitating the initial drug development, such as fermentation, purification, formulation, and test methodologies required in early-stage drug development. We optimize upstream and downstream processes to reduce the time and costs of clinical production and to ensure the highest degree of efficiency and yield during manufacturing. We develop standard operating procedures (SOPs) and batch production records (BPR) that can be readily transferred to larger contract manufacturers for late-stage drug development.

Our PD equipment includes:

• Eppendorf DASGIP Parallel 8-fold bioreactor system: capable of running 8 bioreactor batches
• Eppendorf DASGIP Parallel 4-fold microbial system: capable of running 4 microbial batches
• Eppendorf BioFlo 5L fermenters: 4 units

• Cytiva 25L and 10L rocking motion bioreactors: 2 units
• Shaking incubators
• CO₂ shaking incubators
• AKTA Purifier protein purification systems: 8 units

GMP Manufacturing

Our GMP manufacturing facility includes flexible space for fermentation and purification and ISO 7 modular hardwall cleanroom for vialing. We use various host systems to obtain clinical grade target molecules that are potential drug candidates or intermediates for testing in preclinical studies and phase I clinical trials. The host systems include yeasts, Escherichia coli, insect cells, and mammalian cells (CHO, HEK 293, stem cells, etc). We generate and qualify master cell banks and working cell banks of production cell lines.

Our state-of-the-art equipment includes:

• Eppendorf 150L fermentor for yeast-based fermentation
• Eppendorf 40L fermentor for bacterial fermentation
• Cytiva 100L rocking motion bioreactor for mammalian and insect cell production
• Cytiva 25L and 10L rocking motion bioreactors (4) for mammalian and insect cell production
• Microfluidizer for cell disruption
• Large capacity centrifuges
• Filter holders for single-use depth filters
• Filter holders for microfiltration and ultrafiltration
• Cytiva AKTA Process system (1) and AKTA Pilot systems (2) for purification of target molecules
• Bioprocess columns
• Laminar flow hoods (3)
• Laminar flow cleanbooth
• Modular hardwall cleanroom
• M&O Perry aseptic filling machine

Quality Control

Our quality control (QC) team develops, qualifies, and tests assays to release intermediate molecules, drug substances, and drug products for use in preclinical studies and clinical trials. Our QC experts interact extensively with research and development (R&D), production, and regulatory units, as well as external partners and contract testing laboratories. QC testing includes

• Safety tests: endotoxin and bioburden
• General tests: appearance, pH, conductivity, osmolality, isoelectric point, and TOC (Total Organic Carbon) level
• Impurities: residual host protein level, aggregate level
• Drug concentration: BCA assay, UV extinction coefficient determination, RP-HPLC
• Purities: Coomassie-stained SDS-PAGE, silver-stained SDS-PAGE, HPLC
• Charge variants
• Identity: Coomassie-stained SDS-PAGE, silver-stained SDS-PAGE, Western blot
• Potency: cell-based potency assays, ELISA
• Total cell count and viability

Regulatory and Compliance Support