July 2009

Risk Mitigation and Quality by Design (QbD) Enhancement Through Raw Material Characterization

Interruptions in bioproduction pose serious setbacks for biopharmaceutical companies. Shipping delays, performance variability, quality unknowns, and regulatory issues can delay time to market and ultimately depress a producer’s financial results. Unforeseen variability in process parameters has led the US Food and Drug Administration to insist that biopharmaceutical manufacturers find ways to ensure batch quality of a drug product during manufacture without relying solely on finished product characterization. This challenge is daunting, considering the large number of raw materials required for…

Sandoz: A Provider of Customized Solutions in Biotech Manufacturing

      Sandoz is one of the leading specialists in microbial fermentation of classic and recombinant microorganisms. The company’s comprehensive know-how is based on more than six decades of experience in the field of classical microbial products and more than two decades in recombinant microbial production at commercial scale. Building on this know-how, Sandoz offers a broad variety of integrated services including innovative expression systems, process development, scale up and production of recombinant products derived from microbial systems, and…

Application of Fabsorbent™ F1P HF, a Synthetic Ligand Adsorbent for Capture and Purification of a Single-Domain Antibody Fragment Expressed in

    Figure 1:   Full-length antibody biopharmaceuticals continue to capture significant market due to their validated effectiveness as specific therapeutics. However, more recently it has been recognized that full-length antibodies may not always be necessary because antibody fragments can provide opportunity for new therapeutics with less complicated, higher-yielding production processes such as Escherichia coli and yeast microbial systems. For full-length antibodies, the downstream processing is facilitated by use of protein A–based affinity adsorbents for capture and initial purification; however…

Effect of Prefiltration on Scalability of 0.1-µm Rated Membrane Filters

Figure 1: The effect of prefiltration on the scalability of 0.1-m rated membrane filters is evaluated using a specific cell culture medium that showed reduced filtration throughput (in terms of L/m2) with pleated cartridges. Biopharmaceutical process developers seek to size membrane filters more accurately to improve process economics. Understanding the scalability of filters from discs to pleated cartridges has thus become important. Contradictory claims on the scale-up between different filter configurations have been made in the literature (1, 2). Recently,…

Althea Technologies, Inc.

While CMOs have traditionally been used to play a critical role in the manufacture of drug product, Althea has evolved beyond being a role player to a strategic development and manufacturing partner that can drive value to a client’s product or product candidate. As drug development costs are always increasing, a properly integrated development and manufacturing scheme can significantly decrease development time and expense, while increasing the probability of clinical success and product differentiation. To allow clients to leverage such…

Getting to Clinical Trials Faster with a Better Formulation: Symyx CDMO

      Symyx CDMO (contract development and manufacturing organization) provides a faster, more reliable route to clinical trials by delivering drug product manufactured with a highly optimized and robust formulation. We have over a decade of experience working with the smallest biotechnology start-ups and the largest pharmaceutical companies. Symyx combines formulation expertise, high-productivity research technology, and CGMP manufacturing capability in a single facility.   Biopharmaceutical Development and CGMP Manufacturing   Symyx has the subject-matter expertise and technologies to integrate…

High-Performance Sterile Filtration

Figure 1: Dead-end filters using microporous membranes of synthetic polymers such as PES, polyamide, cellulose acetate, and PVDF are extensively used for microbial control in a wide range of biopharmaceutical liquid filtration applications. Typical applications include sterile media addition into bioreactors, cell harvest clarification, chromatography column protection, and final sterile filtration of purified bulk drug substances. Downstream processing in the biopharmaceutical industry requires multiple bioburden reduction steps that commonly use 0.2-µm sterilizing grade filters. There are innovative application-specific approaches in…

Expression of a Human–Derived Growth Factor Containing Multiple Disulfide Bonds in —Based ēnex Expression Technology™

Figure 1: This protein proved to be “difficult to express” in both mammalian (CHO) and yeast (Pichia pastoris) expression platforms. In CHO cells, expression levels were very low, 1 g/L at the 96-well scale, had deletions of two proteases that when singly deleted showed marginal expression of the growth factor. When those cells are grown in a fermentor, we anticipate a further three- to five-fold increase in titer. These results powerfully demonstrate the utility of the Pfēnex Expression Technology™ toolbox…

A Dedicated Contract Development and Manufacturing Organization Focusing on the Delivery of Advanced Biologics for Customers Worldwide

Angel has provided contract development and GMP manufacturing services for recombinant proteins, antibodies, and vaccines since 2001. Responding to market demand, Angel has also built an impressive track record delivering advanced (live) biologics comprising cell therapies including stem cells, cellular vaccines, and bacteriophages. Angel is one of very few European companies providing specialist GMP manufacturing support of these products for international clients. Comprehensive Solutions Angel offers vertically integrated manufacturing solutions reducing risk, cost, and timelines for clients. We believe that…

Process Development: One Size Does Not Fit All

      SynCo Bio Partners believe that contract manufacturing should not be “one size fits all” and that the biopharmaceutical contract manufacturing industry needs to explore different collaborative business models in the development of production processes with prospective clients. Most CMOs, including SynCo, offer complete, full process, and analytical method development from the upstream fermentation/cell culture stages to the final purification steps. For small virtual companies to larger organizations with limited available internal resources this can be a good…