The advent of laparoscopic surgery and with it Laparoscopic Ventral Mesh Rectopexy (LVMR) has revolutionised the management of internal/external rectal and vaginal vault prolapse. These procedures have traditionally been performed with synthetic meshes. Biologics have gained a prominent role over the last decade in LVMR as well as perineal procedures for rectocoele and cystocoele repair. We exa...

Mass spectrometry (MS) is one of the key techniques in protein characterization. In this article, the workflow for MS-based structural characterization of biologics in biopharmaceutical drug discovery is presented, including characterization of primary and higher order structures. Advances in MS techniques in protein characterization are illustrated, including electron transfer dissociation MS ...

Sujin Kang1,2, Toshio Tanaka1,2, Kazuya Masuda3 and Tadamitsu Kishimoto3* 1Department of Clinical Application of Biologics, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka 565-0871, Japan 2Department of Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine, 2-2 Yamada-oka, Suita, Osaka 565-0871, Japan 3Laboratory of Immune ...

AA-amyloidosis is caused by sustained elevation of serum amyloid A and prolonged inflammation. Although AA-amyloidosis used to be a major cause of death in patients with RA, the incidence of this complication seems to have declined recently [4,5]. Widespread use of Methotrexate (MTX) and the appearance of biologics have changed the treatment of RA. Consequently, complete control of inflammation...

Biologics have revolutionized the therapeutic approach in inflammatory bowel disease (IBD). Anti-tumor necrosis factor (anti-TNF) agents infliximab and adalimumab currently constitute the major biological therapy in IBD. Additional anti-TNFs such as golimumab and other new biologics are currently being developed for both anti-TNF-naïve and -resistant patients. These include anti-integrins (vedo...

Therapeutic monoclonal antibodies (mAbs) represent a milestone in pharmacological development. Their superiority is based on the combination of high specificity, low toxicity, and long half-life that characterizes biologics. If biologics have Achilles' heel, it is their potential immunogenicity. To better understand the impact of the size of immune complexes of mAbs on anti-drug antibody (ADA) ...

DRAFT AGREED BY BIOLOGICS WORKING PARTY 18 April 2007 ADOPTION BY CHMP FOR RELEASE FOR CONSULTATION 24 May 2007 END OF CONSULTATION (DEADLINE FOR COMMENTS) 30 November 2007 AGREED BY BIOLOGICS WORKING PARTY 12 November 2008 ADOPTION BY CHMP 18 December 2008 DATE FOR COMING INTO EFFECT 1 July 2009 This guideline replaces the guideline on “Production and quality control of monoclonal antibodies” ...

The tool of analysis is for us a further development of the historical materialist method, the dialectical method. We will not even waste our time debating the values of Marxism with those who are essentially hung up on white people – hung up to the point of ideological blindness. We understand the process of revolution, and fundamental to this understanding is this fact: Marxism is developed t...

Crohn's disease affects increasing numbers of children worldwide. Generally, childhood-onset disease runs a more severe course than in adults and has a greater impact on quality of life. Therapy in children must take account of a different set of risks for toxicity compared to adults, but also to their longevity. Biologic drugs present remarkable advantages in terms of disease control for child...

Limited analyses of social media content among psoriasis (PsO) and psoriatic arthritis (PsA) patients exist. These may turn to gain insight on treatments such as biologics. This study aims analyze the content, sentiment, engagement posts regarding biologics for PsO PsA. Posts comments discussing were extracted from publicly accessible PsA Reddit groups. assigned higher lower order themes (HOTs ...