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MANUFACTURING OPERATIONS AND SUPPORT
BioProcess Technology Consultants can support manufacturing operations starting from preclinical batches to clinical and conformance batches through commercial batches.
Clinical Manufacturing
BioProcess Technology Consultants has extensive experience in managing and supporting clinical manufacturing operations for both drug substance and drug product at CMOs. We can serve as the person in the plant by being on-site during a manufacturing run or campaign. We can assist in generation of batch records and sampling plans, perform review of executed batch and testing records, and contribute to investigations and trouble shooting.
Validation
BioProcess Technology Consultants has extensive experience in the validation of biopharmaceutical facilities, equipment, and processes. We can prepare Validation Master Plans that are comprehensive and in full compliance with all regulatory requirements (US and foreign). We assist clients in the establishment of documentation standards that are practical and compliant. Using our extensive library of existing documents, protocols, and procedures, we can prepare validation protocols, standard operating procedures, quality test methods, and production batch records suitable for any facility or process. We also provide expert field execution of validation protocols using experienced personnel.
Commercial Manufacturing
Once commercialized, the drug development challenges do not end and the business and regulatory risks become amplified. Our expert process understanding and commercial experience can improve process performance or speed investigations or trouble shooting by providing process technical support in the following areas:
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