Pristine Bioproduction: Updates.

Pristine Bioproduction, LLC is happy to announce that the team has finished its formal business plan for IND-enabling Toxicology supply and contract process development services. We are now seeking first round funding for capital equipment, laboratory lease, salaries, and other startup expenses. Please "contact us" if interested in participating in this funding round. We would be happy to provide an Executive Summary to those interested in further details. Thank you. Tim Matthews CEO, Pristine Bioproduction, LLC

Pristine Bioproduction, LLC is very pleased to announce that it has received a comprehensive market analysis from Peter Latham and Susan Dexter, both at Latham Biopharm group. This research report and the previously received revenue and expense estimates, allows Pristine to confidently proceed forward with a solid business plan that will be use to encourage startup funding for this venture

Pristine Bioproduction is pleased to announce that CRB Engineering Consultants has delivered preliminary design documents for a bulk drug substance manufacturing facility supporting a 1000 liter cell culture production scale. The design is based on the manufacture of monoclonal antibodies in a facility centered wholly on single use technology. The design package includes an overall Project Schedule defining the phases for design, procurement, construction and C&Q, Process Flow Diagrams and a Functional Area Layout Diagram. These early design documents lay the groundwork for subsequent formal conceptual, basic and detailed design and construction of this cGMP CMO facility.

During the past six years, single use systems and devices have emerged as a key change agent in the biomanufacturing landscape. Acceptance in R&D and scale-up has been driven by their effectiveness in reducing risks of contamination, faster changeovers, advantages over fixed stainless steel systems in cleaning and validation, and significantly reduced time, and costs to get a new facility up and running. Now, single use products have pushed beyond an early-stage technology, and are poised to emerge into the much larger, GMP commercial-scale operations. The emergence of single use devices onto the commercial stage is likely to create radical changes in the biomanufacturing landscape.

Manufacturing processes for therapeutic monoclonal antibodies (mAbs) have evolved tremendously since the first licensed mAb product in 1986. The rapid growth in product demand for mAbs triggered parallel efforts to increase production capacity through construction of large bulk manufacturing plants as well as improvements in cell culture processes to raise product titers. This combination has led to an excess of manufacturing capacity, and together with improvements in conventional purification technologies, promises nearly unlimited production capacity in the foreseeable future. The increase in titers has also led to a marked reduction in production costs, which could then become a relatively small fraction of sales price for future products which are sold at prices at or near current levels. The reduction of capacity and cost pressures for current state-of-the-art bulk production processes may shift the focus of process development efforts and have important implications for both plant design and product development strategies for both biopharmaceutical and contract manufacturing companies.