ERP for biologics, vaccines, biosimilars and advanced therapy production
Biologics, vaccines and advanced therapy manufacturers produce products derived from living organisms, including therapeutic proteins, monoclonal antibodies, vaccines, blood products, cell therapies, gene therapies and tissue-engineered products. These products require aseptic manufacturing, biological genealogy tracking, cold-chain management and strict quality control, with regulatory oversight from the Therapeutic Goods Administration and international regulators.
Industry scope. Australia's biologics sector includes multinational biopharmaceutical companies, domestic manufacturers, research institutions and contract manufacturing organisations producing vaccines, plasma products, therapeutic proteins and emerging advanced therapies. The TGA regulates biologics as prescription medicines with additional requirements for biological characterisation, viral safety and immunogenicity assessment. The sector supports public health through the National Immunisation Program and responds to emerging infectious disease threats.
Manufacturing requirements. Biologics manufacturing requires cell culture, fermentation, purification, formulation, aseptic processing, fill-finish and packaging in controlled environments. Manufacturing must maintain cell line or strain genealogy, ensure viral safety, manage process variability, validate analytical methods and maintain process consistency across batches. Advanced therapies require specialised manufacturing for patient-specific products, with unique chain-of-identity requirements.
ERP needs. Biologics manufacturers need ERP systems that support process development, batch record management, biological genealogy tracking, cold-chain management, quality control, stability management and regulatory compliance. ERP must manage complex supply chains for biological raw materials, support aseptic manufacturing controls, track cell banks and viral seeds, manage lot genealogy and enable pharmacovigilance reporting and international regulatory submissions.
Manage process development from research through clinical manufacturing to commercial scale, supporting process characterisation, technology transfer and manufacturing scale-up with version control.
Generate and manage electronic batch records for biologics manufacturing, capturing cell culture parameters, purification steps, formulation actions and critical process parameters.
Track cell lines, viral seeds, working cell banks and biological raw materials through manufacturing genealogy to ensure product consistency, traceability and regulatory compliance.
Manage temperature-controlled storage, shipping and distribution for biologics, vaccines and advanced therapies with continuous monitoring, deviation management and chain-of-custody documentation.
Manage analytical method validation, in-process testing, release testing, stability testing and out-of-specification investigations for biological products with complex characterisation requirements.
Support TGA biologics regulation, manage product dossiers, control regulatory correspondence, manage adverse event reporting and enable international regulatory coordination for global supply.
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