Researcher manufacturing biopharmaceutical products for non-clinical, clinical, and commercial use

BioMARC specializes in manufacturing biopharmaceutical products for non-clinical, clinical, and commercial use under Biosafety Level 3 (BSL-3) and BSL-2 containment (including spore former production) and Select Agent (SA) biosecurity conditions.

In addition to manufacturing and testing services, BioMARC offers product and process development services (both upstream and downstream), which includes the creation of development programs focused on implementation of cGMP regulations and scalability issues. BioMARC has the expertise, experience, equipment, and facilities to take your product from Preclinical, Phase I-III, and through the Commercial manufacturing product life cycle.

Process Development

Process Development is an important component of manufacturing. BioMARC believes that developed processes should be supported by improved understanding of the processes. Good design of experiments and evaluation of results will allow for more efficient and high quality decision making.

Upstream (Bulk Processing) and Downstream (Drug Materials) development studies are designed evaluate the process for intended use. Development is carried out in such a way that the type and scope of the data generated will allow for sufficient evidence of the reproducibility of the process. Development of the process will focus on designing studies and generating data based on critical criteria outlined in the Project Specific Project Plan. Each process control is based on an interpretation of a base of representative data. Processes in which the interaction between critical process parameters and the variable properties of the starting material is not known will be reproduced rigidly to obtain significant data. Process development includes analysis of independent process steps, as well as, the entire production process within a pilot and/or engineering batches. All developmental activities are documented and reported in support of the product’s life cycle.

Cell & Virus Banking

Cell and Virus BankingThe concept of a two-tiered cell or virus bank, in which the Master Cell Bank (MCB; or MVB) which is used to generate Working Cell Banks (WCBs or MVBs), is generally accepted as the most practical approach to providing a supply of cell substrate or viruses for continued manufacture of a cell-based product.

In some microbial expression systems, a new transformation is performed for each new cell substrate container lot, based upon using aliquots of thoroughly tested host cell banks and plasmid banks for each new transformation and on testing of each transformed cell substrate bank. This transformed cell substrate bank is considered the MCB, and it is used as the source of cell substrate for production. Regulatory agencies consider this alternative system adequate because the transformation of bacteria and yeast is generally a very reproducible and easily performed process, unlike the events needed for transfection of metazoan cells.

BioMARC offers cell/virus banking services as part of a larger GMP project or contracted as separate services including evaluating the anticipated utilization rate of the cell/virus bank(s) for production, the expected intervals between generation of new cell/virus bank(s), and the criteria for qualification of cell/virus bank(s).

Analytical Method Development

Researcher Manufacturing for Preclinical Studies, Clinical Trials, and CommercializationAnalytical method development is important for both the early and advanced phases of the product life cycle. As such, analytical methods used in raw material analysis, in-process testing, release testing and cleaning validation/verification associated with GMP biopharmaceutical products are validated, qualified, or verified, as appropriate for the stage of the product. Development of these methods is carried out in such a way that the type and scope of the data generated will allow for sufficient evidence of the reproducibility of the process and in accordance with the industry standards of analysis (i.e., precision, accuracy, limit of detection, limit of quantification, specificity, range and robustness).

Development of a project’s methods will focus on designing studies and generating data based on critical criteria outlined in the Project Specific Master Validation Plan and will include a gap analysis and remediation planning. The end result of development is a method poised for use in the project life cycle.