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Bloomsbury, NJ, United States

Agosti J.K.,Nurse Sharks Inc | Chandler L.A.,Biologics Development | Anderton C.M.,Cardium Therapeutics | Clark R.M.,Nurse Sharks Inc
Ostomy Wound Management | Year: 2013

Clinicians treating pressure ulcers in the elderly in long-term care often face psychosocial, financial, and patient quality-of-life challenges; as such, they seek to identify products that meet wound healing goals as expeditiously as possible. The purpose of this case series was to evaluate outcomes of serial sharp debridement and the application of a formulated collagen gel in patients with chronic, nonhealing pressure ulcers. Three patients (two women ages 82 and 74 years of age and one man 82 years old, all incontinent of bladder and bowel with numerous comorbidities) had wounds >18 months' duration on the buttocks or coccyx that failed to improve despite the use of a wide variety of treatments, including negative pressure wound therapy. All wounds were debrided at the start of treatment and weekly thereafter if necessary, followed by application of the collagen gel. The gel was covered with a sterile bordered gauze and, if needed, a semipermeable dressing. Dressings were left in place for up to 1 week. Two ulcers reepithelialized completely after 4 to 5 weeks of care, and the wound bed of the third ulcer was ready for grafting after 6 weeks of care. No adverse events occurred. Nursing staff appreciated the reduced dressing change frequency, although dressing maintenance remains challenging in patients with frequent incontinence episodes. Randomized clinical trials to evaluate the efficacy of this treatment approach compared to the use of traditional moisture-retentive dressings are needed. Source

Herzer S.,Bristol Myers Squibb | Bhangale A.,Biologics Development | Barker G.,Biologics Development | Chowdhary I.,Biologics Development | And 7 more authors.
Biotechnology and Bioengineering | Year: 2015

A robust, economical process should leverage proven technology, yet be flexible enough to adopt emerging technologies which show significant benefit. Antibody and Fc-fusion processes may capitalize on the high selectivity of an affinity capture step by reducing the total number of chromatographic steps to 2. Risk associated with this approach stems from the potentially increased time frame needed for process development as well as unforeseen changes in impurity profile during first scale-up of drug substance (DS) for animal toxicology and clinical phase I trials (FIH) production, which could challenge a two-step process to the point of failure. Two different purification strategies were pursued during process development for an FIH process of a dAB-Fc fusion protein. A two-step process was compared to a three-step process. The two-step process leveraged additives to maximize impurity reduction during affinity capture. While wash additives in combination with a mixed mode chromatography met all impurity reduction requirements, HCP levels were still higher as compared to the three-step process. The three-step process was implemented for manufacture of clinical material to mitigate risk. © 2015 Wiley Periodicals, Inc.. Source

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