Use of Raman spectroscopy and PCA for quality evaluation and out-of-specification identification in biopharmaceutical products.

Over the past three decades, there was a remarkable growth in the approval of antibody-based biopharmaceutical products. These molecules are notably susceptible to the stresses occurring during drug manufacturing, often leading to structural alterations. A key concern is thus the ability to detect and comprehend these alterations caused by processes, such as aggregation, fragmentation, oxidation levels, as well as the change in protein concentration throughout the process steps, potentially resulting in out-of-spec products.

A New Model-Based Approach for the Development of Freeze-Drying Cycles Using a Small-Scale Freeze-Dryer.

This paper presents a model-based approach for the design of the primary drying stage of a freeze-drying process using a small-scale freeze-dryer (MicroFD® by Millrock Technology Inc.). Gravimetric tests, coupled with a model of the heat transfer to the product in the vials that account also for the heat exchange between the edge vials and the central vials, are used to infer the heat transfer coefficient from the shelf to the product in the vial (K), that is expected to be (almost) the same in different freeze-dryers.

Use of machine learning tools and NIR spectra to estimate residual moisture in freeze-dried products.

Residual Moisture (RM) in freeze-dried products is one of the most important critical quality attributes (CQAs) to monitor, since it affects the stability of the active pharmaceutical ingredient (API). The standard experimental method adopted for the measurements of RM is the Karl-Fischer (KF) titration, that is a destructive and time-consuming technique. Therefore, Near-Infrared (NIR) spectroscopy was widely investigated in the last decades as an alternative tool to quantify the RM.

Management of gynecomastia: an outcome analysis in a multicentric study.

Aim: Male gynecomastia (MG), the most frequent mammary anomaly in human males, is a clinical disease occurring mainly in adolescence and old age. The aim of this study was therefore to analyze 126 consecutive cases of mixed gynecomastia, in order to assess the incidence of early and late postoperative complications and to evaluate the aesthetic results and the quality of life after surgery.

Methods: From January 1st, 2000, to December 31st, 2006 a total of 126 cases of MG were performed by the Plastic Surgery Units of Siena and Pisa.

Effect of lip adhesion on maxillary arch alignment and reduction of a cleft's width before definitive cheilognathoplasty in unilateral and bilateral complete cleft lip.

High tension and tissue dislocation caused by wide maxillary clefts could prevent an optimal aesthetic and functional outcome in primary cheilognathoplasty. Many surgical techniques or conservative (orthodontic and orthopaedic) devices have been proposed for the initial management of infants with complete cleft lip and palate to achieve a tension-free repair of the lip. Adhesion converts a wide unilateral complete cleft into a lesser deformity anatomically similar to an incomplete cleft lip.

Bone regeneration and periosteoplasty: a 250-year-long history.

Background: Since antiquity, many attempts have been carried out and a number of theories proposed to explain the process that leads to bone regeneration. Through manifold experiments, several authors tried to understand and subsequently to control the physiological events that enable bone healing. Between the 18th and 19th centuries something changed.

Merkel cell carcinoma of the lower extremity: report of four cases and new considerations.

Merkel cell carcinoma (MCC) is a rare neuroendocrine cutaneous malignancy that predominantly arises in the head and neck region. We describe clinical features, diagnosis, and treatment in 4 cases of MCC, presenting an uncommon female predominant occurrence and an unusual primary site: the lower limb. In all cases diagnosis was established by histopathologic examination.

Dystrophic-like alterations characterize orbicularis oris and palatopharyngeal muscles in patients affected by cleft lip and palate.

Objective: This study analyzed histological and histochemical features of specimens of the orbicularis oris muscle, and palatal and pharyngeal muscles biopsied during surgery from 33 patients affected by cleft lip and palate.

Design: Three groups were studied: 20 patients affected by cleft palate with or without cleft lip (at the time of primary palatoplasty), seven by cleft lip with or without cleft palate (primary lip closure), and six by cleft lip with or without cleft palate (secondary cheiloplasty). Muscle sections were stained with hematoxylin-eosin, modified Gomori trichrome, ATPase reaction at pH 9.

[The nursing profession in the prison: a descriptive survey].

This article is to notice of the nurse's roll in the prison and the relation between patient prisoner - nurse. The aim of this research is to identify often aspect of nursing in the prison.

Cystathionine beta-synthase c.844ins68 gene variant and non-syndromic cleft lip and palate.

Non-syndromic cleft lip with or without cleft palate (CL/P) is a common birth defect with substantial clinical and social impact and whose causes include both genetic and environmental factors. Folate and homocysteine (Hcy) metabolism have been indicated to play a role in the etiology of CL/P, and polymorphisms in folate and Hcy genes may act as susceptibility factors. We investigated a common polymorphism in the cystathionine beta-synthase (CBS) gene (c.

Genetic analysis of TTF-2 gene in children with congenital hypothyroidism and cleft palate, congenital hypothyroidism, or isolated cleft palate.

Homozygous null mice for thyroid transcription factor (TTF)-2 gene exhibit cleft palate and thyroid malformation. We performed a genetic analysis of the TTF-2 gene in 2 children with congenital hypothyroidism (CH) and cleft palate, 45 children with thyroid dysgenesis, 19 children with isolated cleft palate or cleft lip, 4 patients with thyroid hemiagenesis. The entire coding-region of the TTF-2 gene was analyzed by direct sequencing.

[Echographic aspects of gynecomastia].

Gynecomastia is a size increase of man's breast, due to non neoplastic ductal and glandular stroma proliferation. Prevalent ductal proliferation defines the "florid" type, while prevalent stroma increase defines the "quiescent" type. Pseudo-gynecomastia is a non glandular volume increase.

[A proposal for a protocol for the registration of data on cases of cleft lip and jaw].

The Authors describe a standardized registration system applied to gnathoplasty and its follow-up. That allows both longitudinal growth study and clinical evaluations on the surgical method. If similar standardized registration systems could be adopted by several clinical teams, a comparison between different gnathoplasty methods should be possible and obviously useful.

Reconstruction of cleft maxilla with periosteoplasty.

The principle of gnatoplasty using local periosteal flaps according to Skoog is employed, but an essential modification in reconstructing the cleft maxilla is suggested. The periosteum of the anterior aspect of the maxilla is transferred as an island flap instead of using it as a precarious pedicle flap. The island flap is based on the cheek tissues lying over the periosteum, thereby including the insertions of the mimic muscles.

Repair of skull defects by autogenous bone grafts.

To repair the infant skull as completely and efficiently as possible, the authors describe and recommend greater use of an autogenous graft taking the outer table of the skull from adjacent or symmetrical sites to the defect.