Reference Standards to Support Quality of Synthetic Peptide Therapeutics.

Purpose: Peptides are an important class of therapeutics. Their quality is evaluated using a series of analytical tests, many of which depend on well-characterized reference standards to determine identity, purity, and strength.

Objective: Discuss approaches to producing peptide reference standards, including vialing, lyophilization, analytical testing and stability studies.

Three-Year Outcomes After MACI for Glenoid Cartilage Loss in an Adolescent Athlete: A Case Report.

Case: We report the 3-year outcomes of a 14-year-old boy who anteriorly dislocated his shoulder playing football and suffered a 9-cm2 chondral defect of the anterior glenoid and subsequently treated with matrix-applied characterized autologous chondrocytes (MACI) of the defect with open labral repair.

Conclusion: The management of glenohumeral chondral lesions in adolescent patients remains a challenge. Our case of the successful treatment of a glenoid chondral defect with MACI offers hope as a potential treatment option for adolescent patients with this challenging problem.

Understanding Quality Paradigm Shifts in the Evolving Pharmaceutical Landscape: Perspectives from the USP Quality Advisory Group.

Recent changes in the pharmaceutical industry have led to significant paradigm shifts in the pharmaceutical quality environment. Globalization of the pharmaceutical industry, increasingly rapid development of novel therapies, and adoption of new manufacturing techniques have presented numerous challenges for the established regulatory framework and quality environment and are impacting the approaches utilized to ensure the quality of pharmaceutical products. Regulators, industry, and standards-setting organizations have begun to recognize the need to rely more on integrated risk-based approaches and to create more nimble and flexible standards to complement these efforts.

Reported Technical Aspects of Type II SLAP Lesion Repairs in Athletes.

Purpose: To systematically review the available literature to further describe and report the available data on SLAP repair techniques and the association with outcomes.

Methods: A systematic review of literature was performed on manuscripts describing type II SLAP repairs in athletes. Selection criteria included studies reporting exclusively type II SLAP tears without concomitant pathology, minimum 2-year postoperative follow-up, use of anchor fixation, and return to previous level of play data available.

Quantitative Analysis of Impurities in Unfractionated Heparin of Bovine Origin.

The USP heparin sodium monograph lists impurities with specifications developed for porcine derived products. Most of these impurities are of biological origin and are present in porcine intestinal mucosa, the tissue source used in the production of porcine heparin. One of the specified impurities, oversulfated chondroitin sulfate (OSCS), has been introduced in the monograph to detect intended adulteration of heparin products with this impurity.