Rise can carry out high-quality research and master cell banking useful for product development and GMP manufacturing purposes

All cell banking activities are carried out in validated ISO-5 infrastructure with high standards of documentation and compliance

Significant experience in media optimization and upstream bioprocess development

Technology advancements in scalable purification development & freeze-drying optimization

Considerable expertise in GMP technology transfer and developing production-ready processes

Establish, qualify, and transfer assays for Strength, Identity, Potency, Purity and General Characteristics for Master Cell Banks, Drug Substances and Drug Products

Assays can be qualified and validated for their intended use, as necessary, and routine testing can be carried out

With expertise in capsule-based drug product formulation, we can carry out capsule development for small & large capsule fills for purposes of process development and initial stability assessments

Perform preclinical studies both in vitro (bile-salt studies, antibiotic susceptibility) and for in vivo readouts (tox studies)

We can deploy a range of analytical methods (PCR-based, ELISA-based and microbiology-based assays) to develop GLP-ready assays for toxicology sample testing

Production of material for toxicology studies that is representative of future GMP campaigns for Drug Substance / Drug Product

Tox lots can be produced in ISO-5, ISO-7, or ISO-8 as the application demands

With our deep expertise in assay development, we also provide GLP assay testing that is carried out under full QA oversight

We can carry out GLP assay studies to support toxicology and clinical studies

A full suite of capabilities related to fermenter and bioreactor production of drug substance using single-use technologies; freeze-drying in validated lyophilizers 

Can carry out GMP manufacturing activities with appropriate quality systems, materials control, GMP documentation and quality assurance while accommodating a person-in-plant

Authoring of pre-IND packages and regulatory responses

Support in generating data necessary to fulfil regulatory comments

Help with completing IND sections for products for which we have supported development and/or manufacturing

Advise and expertise in structuring regulatory submissions and responses

Strategy insights when evolving a regulatory approach for a new LBP candidate

Quality advise during the establishment of a manufacturing plan for a new lead

Expertise in selecting raw materials that meet requisite standards for LBPs and satisfy quality standards during production

Material selection or vendor qualification support

Support with preparing for and responding to questions from regulatory discussions

Staff available for FDA meetings

With a fully established Quality Assurance infrastructure, we can offer QA audit of non-clinical sites that undertake toxicology studies

Assessments of materials, documents, manufacturing processes, and production sites