Biotechnol. Appl. Biochem. (1998) 29, 1 - R. Lundblad

Biotechnology and Applied Biochemistry (1999) 29, (1–1) (Printed in Great Britain)

PDF

Editorial

Ambient temperature and other issues in the research and development process – relationship to experimental procedures reported in Biotechnology and Applied Biochemistry

Christine V. Sapan, Henry S. Kingdon AND Roger L. Lundblad

Boca Raton, Florida, Deerfield, Illinois and Duarte, California

We have recently had the opportunity to participate in a variety of processes related to the evaluation and validation of manufacturing processes in our various organizations. During this exercise, we have had the pleasure of becoming reacquainted with cGMP (current Good Manufacturing Procedures) regulations as well as those supporting GLP (Good Laboratory Practices). As such, we have again grown to appreciate the absolute rigour necessary in documentation such as standard operating procedures (SOPs) and related assay procedures to absolutely assure reproducibility in the manufacturing process.

Since the editorial focus of Biotechnology and Applied Biochemistry is directed toward the development, manufacture and characterization of biopharmaceuticals and related diagnostics, it is strongly suggested that authors carefully review their experimental section with respect to such details as, for example, temperature. For example, what does room temperature or ambient conditions mean? Furthermore, does surrounding temperature accurately reflect vessel or reaction temperature? This consideration also holds for pressure, time, volume and all other experimental variables, including mixing speed and vessel geometry.

The careful documentation of the above information in the research and development process can effectively drive good technology transfer and scale-up toward successful implementation in manufacturing. It is clear that the research and development phase of biopharmaceutical development is expected to provide the rationale for the conditions used in the manufacturing process.

Equal consideration of these issues needs to be given to the development of both diagnostics and devices. In both of these situations, there is a formal consideration of a product design process. Such a product design process would be useful for the development of biopharmaceuticals.

Finally, it is also clear that the above considerations have equal application to the academic sector, where there is increasing requirement for a quality assurance process. This concern is driven by a variety of pressures, including intellectual property development, collaborative research with industrial concerns and oversight by both granting agencies and university administrations.

In consideration of the above issues, the editorial review process for Biotechnology and Applied Biochemistry will now include the rigorous review of the experimental section of all manuscripts submitted for publication. Manuscripts which do not adhere to cGMP, GLP or equivalent regulations with respect to the description of the experimental process will be returned to the authors for revision prior to consideration for publication.