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Biopharmaceutical Contract Manufacturing at the Crossroads

by Roger Lias, PhD
Volume 2, Issue 3 (May/June 2003)

Contract manufacturing of recombinant protein drugs and vaccines, as well as other biopharmaceuticals, has been the focus of considerable interest during the past decade. Fueled by a strong clinical development pipeline, primary manufacturing of biopharmaceuticals on a contract basis has attracted multinational industrial concerns willing to invest on the promise of potentially higher returns than are experienced in the production of traditional small molecule drugs. Biopharmaceutical contract manufacturers have made significant contributions to the development and subsequent commercialization of a few highly successful products. However, despite strong growth, consistent profitability has been elusive. The market has changed overr the past decade as customer projects progressed from process development through market launch. Now that several preeminent market players have successfully made the difficult transition from clinical to commercial supplier, what has been learned and how is the market expected to evolve over the next five years?...

Lias R. Biopharmaceutical Contract Manufacturing at the Crossroads.
BioProcess J, 2003; 2(3): 19-23.

Bioreactor Process Selection for Large-Scale Manufacture of Monoclonal Antibodies — Tradeoffs and Recommendations

by Mina D. Mahadevan, PhD
Volume 2, Issue 3 (May/June 2003)

Bioreactor productivities are highly dependent on the process used to cultivate mammalian cells. These productivities directly affect the manufacturing plant capacity, and thereby the economics of production of monoclonal antibodies (MAbs). Historically, companies have chosen bioreactor process strategies that emphasize simplicity of scale-up at the expense of productivity, and conducted manufacturing using well-characterized and relatively straightforward batch processes. Such processes have successfully produced small or moderate quantities (ranging from ~100 g to ~ 1 kg per lot) of the desired antibody. Given the anticipated demand for large-scale quantities of MAbs (and the high stakes for the companies investing in these new biological entities), it is worthwhile to revisit these past selection strategies and see if — and under what conditions — they remain optimal today...

Mahadevan MD. Bioreactor Process Selection for Large-Scale Manufacture of Monoclonal Antibodies — Tradeoffs and Recommendations.
BioProcess J, 2003; 2(3): 25-31.

Biopharmaceutical Contract Manufacturing: An Overview

by David Sherwood, PhD
Volume 2, Issue 3 (May/June 2003)

The revolution in biotechnology has led to 133 biotechnology-derived medicines being approved by 2001 with sales of $22 billion. This is less than 10 percent of today's total pharmaceutical market, but it is a rapidly growing sector. Biologics are predicted to grow to nearly $50 billion by 2008. Marketed biopharmaceuticals include several blockbuster products with multibillion-dollar sales. In recent years, biotechnology-derived therapies represented 10 percent to 20 percent of all new approved molecular entities and hundreds more are in development, including nearly 200 proteins in late-stage trials. Microbial and mammalian expression systems are typically used to produce biotherapeutic proteins (many companies are also working on transgenic expression systems). Microbial cultures (typically, Escherichia coli or yeast) are used to produce smaller, less-complex proteins or those where specific modifications, especially glycosolation, are not required...

Sherwood D. Biopharmaceutical Contract Manufacturing: An Overview.
BioProcess J, 2003; 2(3): 33-35.

Structure Characterization of a Recombinant Monoclonal Antibody with One- and Two- Dimensional High Performance Liquid Chromatography with On-line Electrospray Ionization Mass Spectrometry

by Brooks R. Sunday
Volume 2, Issue 3 (May/June 2003)

Recombinant monoclonal antibodies (rMAbs) are the predominant biotherapeutic protein under development today. FDA requires the structure characterization if rMAbs and other recombinant proteins to grant marketing approval. Characterizing such complex, inherently heterogeneous molecules is a significant analytical challenge that requires a broad array of physico-chemical tests. This article reports the use of reversed phase high-performance liquid chromatography (RP-HPLC) with on-line electrospray ionization mass spectrometry (ESI-MS) to rapidly determine the glycoform composition and the heavy chain C-terminal lysine heterogeneity of an intact rMAb. In addition, a novel multidimensional chromatographic platform was developed to investigate the two-dimensional, size exclusion chromatography (HPSEC) separation of the rMAb followed by RP-HPLC (HPSEC-RP-HPLC) with on-line ESI-MS analysis. Such analyses can characterize, identify, and confirm the structure of an intact rMAb...

Sunday BR. Structure Characterization of a Recombinant Monoclonal Antibody with One- and Two- Dimensional High Performance Liquid Chromatography with On-line Electrospray Ionization Mass Spectrometry.
BioProcess J, 2003; 2(3): 37-45.

Viral Gene Vectors

by Sybille L. Sauter
Volume 2, Issue 3 (May/June 2003)

An astonishing range of viruses has provided building blocks for gene delivery systems, from the simple adeno-associated virus with a 5 kb genome to the complex poxviruses with 300 kb. This review focuses on non-replicating viral vectors that infect host cells just once, without producing infections virus. Viral vectors are generally characterized by several criteria, including their ability to integrate into the host genome, coding capacity, titer, toxicity, immunogenicity, host range, duration of gene expression, and transient or stable production systems. These are precisely the features that need to be carefully studied in the context of the application when deciding which vector to use...

Sauter SL. Viral Gene Vectors. BioProcess J, 2003; 2(3): 56-61.

Adenovirus Reference Materials: Determination of Particle Concentrations Obtained by Orthogonal, Physical-Chemical Methods

by Elisabeth Lehmberg, PhD, Paul Shabram, Thomas Schluep, ScD, Shu Fen Wen, PhD, Barry Sugarman, PhD, Maria Croyle, Michael Koehl, Edwige Bonfils, PhD, Daniel Malarme, Geoffrey Sharpe, PhD, Heike Nesbit, PhD, Flavia Borellini, PhD, Amine Kamen, PhD, Beth Hutchins, PhD, and Gary Vellekamp, PhD
Volume 2, Issue 3 (May/June 2003)

With the continued progress of adenoviral vectors in gene therapy studies it is increasingly evident that a more formalized approach to the characterization and analysis of these viral vectors is urgently needed. Today, adenoviral vectors are beginning to be considered "well characterized biologics," as shown by numerous publications describing sophisticated analytical approaches for recombinant adenovirus product candidates. Because the analytical definitions of adenoviral vectors currently lack comparison to a common standard, the problem for regulatory agencies is how to objectively evaluate safety in relation to the administered dose. This well-recognized need for an adenovirus standard has been addressed by a consortium of representatives from regulatory agencies, industry, and academic organizations — the Adenoviral Reference Material (ARM) Working Group. Its work has come to fruition in the recent public availability of the ARM, a purified wild type 5 adenovirus. Many aspects of the history, production, and characterization of the ARM have been published in detail...

Lehmberg E, Shabram P, Schluep T, Wen SF, Sugarman B, Croyle M, Koehl M, Bonfils E, Malarme D, Sharpe G, Nesbit H, Borellini F, Kamen A, Hutchins B, Vellekamp G. Adenovirus Reference Materials: Determination of Particle Concentrations Obtained by Orthogonal, Physical-Chemical Methods. BioProcess J, 2003; 2(3): 50-55.

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