Company Overview of Catalent Pharma Solutions, Inc.
Catalent Pharma Solutions, Inc. provides development solutions and delivery technologies for drugs, biologics, and consumer health products. The company’s Development and Clinical Services segment offers manufacturing, packaging, storage, and inventory management services for drugs and biologics in clinical trials. This segment also provides analytical chemical and cell-based testing and scientific services; respiratory products formulation and manufacturing; regulatory consulting; and bioanalytical testing for biologic products. Its Oral Technologies segment offers oral delivery technologies, including formulation, development, and manufacturing services for the oral dose forms comprising p...
14 Schoolhouse Road
Somerset, NJ 08873
Key Executives for Catalent Pharma Solutions, Inc.
Chief Executive Officer, President and Director
Chief Financial Officer, Principal Accounting Officer and Executive Vice President
Senior Vice President of Global Operations
Group President of Clinical Supply Services
President of Oral Technologies - Modified Release Technology
Compensation as of Fiscal Year 2015.
Catalent Pharma Solutions, Inc. Key Developments
3M and Catalent Obtain Outstanding Results in Purification and Clarification with 3M Emphaze AEX Hybrid Purifier
Aug 19 15
Catalent Pharma Solutions and 3M Purification Inc., recently investigated a novel purification approach that significantly increased the performance of the mAb purification process by enhancing the efficiency of the Protein A column. The process resulted in a substantially pharmaceutically pure product immediately after Protein A elution. The global monoclonal antibody (mAb) market exceeded USD 80 billion in 2013, and is predicted to top USD 100 billion in 2015. To sustain this rapid market growth into the future, the biopharmaceutical industry requires increasingly efficient mAb purification processes from discovery to commercial manufacturing.To meet this increasing product demand, product titers are increasing, pushing cell culture density and duration to increase. These cell culture characteristics lead to higher contaminant levels which, in turn, can affect the efficiency of Protein A chromatography. Protein A will continue to be the primary capture step of choice due to its specificity and ability to yield pure product. However, the increased contaminant load can cause the purity of the Protein A eluate to drop from 99.9% to the 98-99% range. While the exact causes and mechanisms of the decrease in Protein A column performance are still a very active topic of research, high concentrations of chromatin in cell culture fluid has been suggested to be a major agent that interferes with Protein A chromatography, and acts as a precipitation catalyst at various stages of the process. 3M Emphaze AEX Hybrid Purifier, the first single-use chromatography purification product line introduced by 3M, is designed to help biopharmaceutical manufacturers achieve high product purity early in the manufacturing process because this can markedly improve efficiency and process economics. The result is an all-synthetic clarifying product line containing both a novel anion exchange functional nonwoven-supported hydrogel and a fine particle, bioburden reduction membrane. The 3M Emphaze AEX Hybrid Purifier utilizes the high capacity Q-functional hydrogel and 0.2 µm polyamide membrane to provide a high degree of soluble and insoluble contaminants reduction. When used at the clarification stage, it is capable of providing greater than 4 log reduction of DNA in the cell culture fluid often with throughputs over 400 L/m2. To decrease the chromatin content of the cell culture fluid, Catalent incorporated a 3M Emphaze AEX Hybrid Purifier capsule in the place of a fine grade depth filter in the primary recovery process. In this process position, the results were outstanding, including greater than 4 logs reduction in DNA and an increase in the efficiency of the protein A eluate pool to nearly injectable product purity. Catalent perceives the consequences of this enhanced process performance to be far reaching. Depending on the specific process, it may enable: restructuring and simplification of the downstream polishing train and; elimination of the polishing train in the cases where product aggregate content is sufficiently low and final viral clearance is not required.
Amarantus Bioscience Holdings, Inc. Announces Manufacturing Agreement with Catalent Pharma Solutions
May 14 15
Amarantus BioScience Holdings, Inc. announced that it has entered into a manufacturing agreement with Catalent Pharma Solutions (CTLT), the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, for clinical-grade production of MANF (mesencephalic-astrocyte-derived neurotrophic factor). Under the agreement, Catalent will provide all cell line engineering, process development and clinical Good Manufacturing Practices (cGMP) biomanufacturing activities necessary for the rapid development of a high performance cell line expressing MANF protein that will thereafter be advanced into scale up for cGMP production. The project will utilize Catalent's proprietary GPEx technology, which creates high-expression, extremely stable cell lines with speed and efficiency, typically capable of getting drug development projects to clinic in one-third the time of traditional approaches. The advantages of applying GPEx technology span from early feasibility studies, to clinical manufacturing and commercial scale production. MANF is a naturally-occurring protein that reduces and prevents apoptosis (programmed cell death) in response to injury or disease. Amarantus is developing MANF for the treatment of orphan ocular indications, including retinitis pigmentosa (RP), and recently received orphan drug designation for MANF for the treatment of RP in the United States and in Europe. In addition, MANF proteins have demonstrated proof-of-concept in animal pre-clinical models to treat a wide range of conditions including retinal artery occlusion, glaucoma, Parkinson's disease (PD), diabetes and ischemic heart disease, among others. With this announcement, Amarantus is initiating Investigational New Drug enabling (IND-enabling) studies to support a first-in-man clinical study with MANF. The Company has retained regulatory expertise to identify the fastest path to human proof-of-concept data by evaluating well-respected regulatory pathways available worldwide, and will be working judiciously towards this objective. Amarantus is targeting the initiation of first-in-man clinical studies for MANF in 2016.
Catalent Pharma Solutions Expands Manufacturing Facility in Winchester, Kentucky
Apr 24 15
Catalent Pharma Solutions has expanded its manufacturing facility in Winchester, Kentucky. The expansion has seen the doubling of its footprint to 180,000sq.ft. The expansion features newly installed fluid bed capacity, expanded analytical laboratories, and an advanced, open facility design that provides flexibility in supporting the requirements of new customer programs. The expansion was completed in response to increased customer demand for the manufacture of complex, oral solid formulations.
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