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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..


News Article | February 15, 2017
Site: www.prweb.com

The International Society for Pharmaceutical Engineering (ISPE) and its Facility of the Year Awards (FOYA) program today announced its 2017 Category Award winners: FOYA’s judging panel has also awarded Honorable Mentions to: This premier global awards program recognizes innovation and creativity in manufacturing facilities serving the regulated healthcare industry. Projects selected for the FOYA program set the standard for pharmaceutical facilities of the future by demonstrating excellence in facility design, construction, and operations. “We are proud to honor these eight organizations that share ISPE’s commitment to innovate and advance pharmaceutical manufacturing technology for the benefit of all global patients,” said John Bournas, ISPE CEO and President. 2017 Facility of the Year Category Award Winners Abbott is the winner of the Operational Excellence category for success of its “Operational Excellence – A New Quality Approach" project initiated at the Abbott Diagnostics facility in Longford, Ireland. The site has increased productivity, improved changeover efficiencies, eliminated backorders, and enhanced product quality--while also reducing cost per unit, cycle times, equipment down-time, and inventory holdings. Bristol-Myers Squibb won the Facility Integration category for its Biologics Development Building and the Clinical Manufacturing Building project located in Devens, Massachusetts, USA. These facilities were recognized as outstanding examples of how to integrate new capabilities within an existing plant through careful design, good collaboration, as well as creative engineering. Cook Pharmica is the winner of the Equipment Innovation category for its Flexible Filling Line project in Bloomington, Indiana, USA. This collaborative development between owner, suppliers, and engineering experts delivered a novel application of commercially available and custom developed equipment innovation manufacturing solutions that drove superior commercial market changing technology and supply chain flexibility in a unique “ready-to-use” vial platform. Eli Lilly and Company has been awarded winner of the Process Innovation category for its Continuous Direct Compression Manufacturing Kits 2 & 3 project located in Indianapolis, Indiana, USA and Carolina, Puerto Rico. Their forward thinking approach brought on the implementation of Continuous Direct Compression (CDC) Process and other process innovations in their oral solid dose (OSD) facilities across their manufacturing network. Eli Lilly and Company has also been named winner of the Facility of the Future category for its process development, production platform commitment, and deployment of three replicate operational continuous oral solid dosage (OSD) production facilities. Fundamental to the success of the project was the development of the progressive mass balance control scheme anchored by advanced automation and PAT technology— key to insuring consistent control, low process variability, and high quality assurance. Jazz Pharmaceuticals Ireland Limited is the winner of the Project Execution category for its creation of a greenfield manufacturing facility in Athlone, Ireland. Having no prior experience internally on building or operating a manufacturing facility, the Jazz “Project Rock” approach was highly pragmatic, and a model for lean project execution and integration of the investment from “project” phase to licensed GMP operations. Nephron Pharmaceuticals Corporation received an Honorable Mention for its facility in West Columbia, South Carolina, USA. The Nephron SC project was recognized for its use and integration of a suite of industry leading technologies such as laser guided vehicles, automated warehousing, robotics to eliminate human intervention, and track and trace technology. Novartis-Penn Center for Advanced Cellular Therapies received an Honorable Mention for its Center for Advanced Cellular Therapies (CACT) project in Philadelphia, Pennsylvania, USA. The facility leverages pharmaceutical engineering principles to successfully merge academic, corporate, and medical considerations thereby creating an innovative center to advance personalized medicine. PT. Kalbio Global Medika received an Honorable Mention for its greenfield Biotech Facility project in Jakarta, Indonesia. Kalbio’s young and highly motivated project team is an outstanding example of the “can do spirit”. It is a fine demonstration of the talent and potential for biomanufacturing in the region. The 2017 FOYA Category Winners will be formally recognized at the ISPE Facility of the Year Awards Banquet on 6 June 2017, in Arlington, Virginia, USA. The banquet, held in conjunction with the ISPE/FDA/PQRI Quality Manufacturing Conference, will feature presentations from the FOYA judging panel and other noted industry leaders. The 2017 FOYA Overall Winner will be announced at the 2017 ISPE Annual Meeting & Expo from 29 October – 1 November in San Diego, California, USA. Winners will also have the opportunity to make presentations during educational sessions at the ISPE Annual Meeting. About the ISPE Facility of the Year Awards Program Established in 2004, The Facility of the Year Awards (FOYA) recognize state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery. The FOYA program provides a platform for the pharmaceutical science and manufacturing industry to showcase its accomplishments in facility design, construction, and operation, while sharing the development of new applications of technology and cutting-edge approaches. Visit http://www.FacilityOfTheYear.org for more information. About ISPE The International Society for Pharmaceutical Engineering (ISPE) is the world’s largest not-for-profit association serving its members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The more than 18,000 members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Bethesda, Maryland, USA, and an operations and training center in Tampa, Florida, USA. Visit http://www.ISPE.org for more information.


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.

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