Biotech Law

A tale of two specificities: bispecific antibodies for therapeutic and diagnostic applications

Hannah Byrne, Paul J. Conroy, James C. Whisstock, Richard J. O’Kennedy. • Recombinant DNA technologies are leading the rapid expansion of bispecific antibody formats.• The therapeutic potential of bispecific antibodies is being realized ….

Bringing policy relevance and scientific discipline to environmental risk assessment for genetically modified crops

Rod A. Herman, Monica Garcia-Alonso, Raymond Layton, Alan Raybould. Although public opinion is important in deciding what is valued by society, governments have determined that scientific expertise is required to evaluate potential environmental effects of genetic….

Toward aggregation-resistant antibodies by design

Christine C. Lee, Joseph M. Perchiacca, Peter M. Tessier. • Therapeutic antibodies possess highly variable propensities to aggregate.• Antibody CDRs, frameworks, and domain interfaces strongly influence solubility.• Co….

Potency evaluation of tissue engineered and regenerative medicine products

Kelly Guthrie, Andrew Bruce, Namrata Sangha, Elias Rivera, Joydeep Basu. • Potency is the specific ability or capacity of the product to effect a given result.• Cell-based therapies as well as engineered tissues and neo-organs do not alwa….

Cellulases for biomass degradation: comparing recombinant cellulase expression platforms

Megan Garvey, Holger Klose, Rainer Fischer, Camilla Lambertz, Ulrich Commandeur. • Each organism has different strengths and weaknesses in recombinant glycosyl hydrolase (GH) expression.• Advances using yeasts and plants show particularly great p….

Does genomic selection have a future in plant breeding?

Elisabeth Jonas, Dirk-Jan de Koning. • Successful implementation of GS for crop breeding cannot be achieved by a ‘copy and paste’ of GS in dairy cattle.• The variety of crop breeding schemes presents ch….

Continuous downstream processing of biopharmaceuticals

Alois Jungbauer. • Overview of continuous downstream processing.• Unit operations suited to continuous manufacturing.• Description of reactors used in continuous downstream proc….

Marker-free plasmids for biotechnological applications – implications and perspectives

Pedro H. Oliveira, Juergen Mairhofer. • Plasmid gene delivery is a promising approach for the prevention and treatment of disease.• Use of antibiotic selection markers is linked to a wide range of detrim….

The physics of tobacco mosaic virus and virus-based devices in biotechnology

J.M. Alonso, M.Ł. Górzny, A.M. Bittner. • Diffraction and cryo-EM provide a detailed picture of TMV in various states, even during assembly.• TMV is surprisingly resilient against many polar organic solven….