Genetic Engineering & Biotechnology News

MAY15 2017

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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Genetic Engineering & Biotechnology News | GENengnews.com | MAY 15, 2017 | 21 provide more detailed information than be- fore," comments Dr. Petrie. Quality considerations set forth by the FDA also highlight the necessity of study- ing biotherapeutics under the same envi- ronmental conditions the protein will face during manufacturing and storage, and even during its time in the body. Chemical modi- fications that can result in response to en- vironmental factors, such as oxidation and deamidation, can elicit unwanted immune responses to the drug. Hyper-Reaction Monitoring Biognosys, a Switzerland-based company that specializes in developing and providing proteomics technology, uses a novel work- flow based on high-resolution mass spec- trometry called hyper-reaction monitoring (HRM). In contrast to classical proteomics methods, where each peptide is analyzed sequentially, HRM fragments all peptides together, which "provides deep and com- prehensive data," according to Biognosys' co-founder and CEO, Oliver Rinner, Ph.D. "HRM is especially suited for very complex samples, but also for samples with very large differences in protein quantity, like biothera- peutics, where certain modifications occur only in very low stoichiometry." Whereas Biognosys' main focus is on ana- lyzing complex proteomes, they also work with isolated proteins—characterizing the presence of modifications and identifying "breaking points" that make the protein sus- ceptible to oxidation and other degradation pathways. One of the things Biognosys does very well, asserts Dr. Rinner, is facilitate com- parisons across conditions. For example, the company's technology can help researchers "test certain differential conditions, like stor- age conditions." Biognosys has also devel- oped a kit for determining indexed retention time (iRT), an empirically derived dimen- sionless peptide-specific value that allows for highly accurate RT prediction, and signal processing software (Spectronaut™) that can deconvolute the highly dimensional data HRM produces. Data Analysis It takes the "right type of software tools" to handle the terabytes of data that mass spectrometry analyses generate, asserts Eric Carlson, Ph.D., president and CEO at Pro- tein Metrics. "Without the right type of software tools, the analysis would really be left to a small handful of individual experts. Having the right software tools really allows this type of analysis to be brought main- stream." Protein Metrics offers a suite of analytical modules that work with their search engine, Byonic™, to enable protein characterization: Byologic ® , Byomap™, and Intact Mass™. Byologic enables detailed inspection of mass spectra. Using this module, analysts can characterize proteins and their post-trans- lational modifications and other variants in greater detail, compare multiple samples, and perform label-free quantification. Byomap allows analysts to look at data obtained from both mass spectrometry and chromatography instruments, such as high- performance liquid chromatography (HPLC) or capillary electrophoresis (CE). The soft- ware module can generate a reference stan- dard to identify and annotate different chro- matographic peaks using mass spectrometry data to simplify downstream processes, like lot release. Finally, Protein Metric's Intact Mass soft- ware analyzes mass spectra of undigested mol- ecules, often referred to as the "top-down" ap- proach to protein analytics. Top-down analy- sis is a much faster technique that requires less sample prep than the alternative "bottom-up" method. But if there is a post-translational modification on the molecule, this method does not allow localization. Protein Metric's software is vendor-inde- pendent, which creates continuity and con- sistency for pharmaceutical companies with multiple instruments from different vendors. "All the reports can look the same, and all the methods can look the same," stated Dr. Carl- son. "That's how we can be very consistent. Analysts can spend their time focusing on the samples—as opposed to developing new meth- ods that work only on their instruments." Mass spectrometers and separation tech- nologies have incorporated advances that improve resolution and thereby enable re- searchers to see small, subtle differences between samples. Although these advances make datasets more difficult to analyze, Dr. Carlson views them as "an opportunity for a software company to really be able to provide data analysis for these more compli- cated datasets." As scientists continue to intercept and de- cipher the messages that post-translational modifications send, biopharmaceutical com- panies will have an opportunity to translate these discoveries into better drug design and development—but it all relies on the analyti- cal methods and tools available to interpret the language of proteins. CREATING TOMORROW'S SOLUTIONS THE MICROBIAL CMO Are you looking for a commercial manufacturer of biopharmaceuticals for clinical and market supply? We are the microbial CMO and your partner of choice. With 25 years' experience in process development, validation and manufacturing, we off er a wealth of expertise in commercial production: starting with development from scratch, through transfer of approved processes to our EMA-approved / FDA-inspected manufacturing lines and manufacturing for market supply. To round off our services in the fi eld of clinical and approved products, we provide WACKER's proprietary cost- saving E.coli technologies based on secretory protein production (ESETEC ® ) and protein refolding (FOLDTEC ® ). Put your trust in our experience! Wacker Biotech GmbH, Jena and Halle, Germany, Tel. +49 3641 5348-206, info.biologics@wacker.com, www.wacker.com/biologics Bioprocessing Many different types of post-translational modifications exist. After these modifications are identified by mass spectrometry, they can be further scrutinized by antibodies, such as those developed by Rockland Immunochemicals, that can specifically recognize the modified residue and the surrounding amino acids, but not the non-modified sequence or different sequences with the same modification. EAG Laboratories uses high-res MS to help its clients characterize biotherapeutics, which can be hard to analyze if they carry synthetic add-ons. (This antibody-drug conjugate could harbor several distinctive features.)

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