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Rise BioServices is focused on leveraging our expertise and infrastructure to support product development and manufacturing needs of our clients and partners

Rise CDMO Services

Microbiome products are gaining widespread medical relevance. Rise BioServices is at the forefront of microbiome science and, with our technology edge, offers better solutions for clean space manufacturing of novel microbiome-based medicines and products. Utilizing our scientific and regulatory expertise in Live Biotherapeutics Products (LBPs) and other bacterial products, we support emerging and established companies in all aspects of product development and manufacturing.

Specializing in Live Biotherapeutics Products (LBPs)

Specializing in Live Biotherapeutics Products (LBPs)

Structured to support rapidly growing LBP industry

Structured to support rapidly growing LBP industry

Flexible clean space GMP manufacturing

Flexible clean space GMP manufacturing

Our Focus is Microbiome Products

  • Gamut of services necessary to advance a research concept to clinical evaluation
  • Deep understanding of cost-benefit of manufacturing and speed to clinic
  • Pilot Phase 1/2 development and production with commercial scale in mind
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Product Development Areas We Support

With a fully integrated product development and manufacturing infrastructure to support microbial products, Rise BioServices can help prepare products for human use.Our extensive scientific and management experiences allow us to offer customized services that meet the diverse needs of our partners in all phases of development.

Development Services

Bacterial Strain Engineering
Expertise in synthetic biology methodologies for developing organisms with directed functionality

New strains can be engineered as per regulatory environmental controls
Assay Development

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

Microbial GMP Services

Master Cell Banking
GMP Master Cell Banking done in an ISO-5 Cleanroom with Environmental Monitoring

A Full GMP Suite with Material Control, Document Control, Environmental Controls, Quality Assurance and Management Review
GLP Testing

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

Regulatory and IND-Enabling Services

Pre-IND Package

Authoring of pre-IND packages and regulatory responses

Support in generating data necessary to fulfil regulatory comments

Raw Material Selection

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

Material selection or vendor qualification support

Facilities and Equipment

Infrastructure to support pilot-scale Phase 1/2 clinical production

Flexible, fit-for-purpose clinical GMP clean space environment

ISO-5 Clean Environment for critical GMP operations with ISO 7 supporting areas