Advertisement

Topics

PubMed Journals Articles About "CatalentPharma Invests 200M Fast Growing Biologics Manufacturing Business" RSS

15:19 EST 21st February 2019 | BioPortfolio

CatalentPharma Invests 200M Fast Growing Biologics Manufacturing Business PubMed articles on BioPortfolio. Our PubMed references draw on over 21 million records from the medical literature. Here you can see the latest CatalentPharma Invests 200M Fast Growing Biologics Manufacturing Business articles that have been published worldwide.

More Information about "CatalentPharma Invests 200M Fast Growing Biologics Manufacturing Business" on BioPortfolio

We have published hundreds of CatalentPharma Invests 200M Fast Growing Biologics Manufacturing Business news stories on BioPortfolio along with dozens of CatalentPharma Invests 200M Fast Growing Biologics Manufacturing Business Clinical Trials and PubMed Articles about CatalentPharma Invests 200M Fast Growing Biologics Manufacturing Business for you to read. In addition to the medical data, news and clinical trials, BioPortfolio also has a large collection of CatalentPharma Invests 200M Fast Growing Biologics Manufacturing Business Companies in our database. You can also find out about relevant CatalentPharma Invests 200M Fast Growing Biologics Manufacturing Business Drugs and Medications on this site too.

Showing "CatalentPharma Invests 200M Fast Growing Biologics Manufacturing Business" PubMed Articles 1–25 of 5,900+

Ensuring Product Quality, Consistency and Patient Supply over Time for a Large-Volume Biologic: Experience with Remicade.

Biologics are produced from living organisms in complex, multi-stage manufacturing processes and contain inherent variability, which must be understood and controlled during manufacturing to avoid unexpected changes in key quality attributes that may contribute to clinically meaningful differences. The process must also meet large commercial demand, while simultaneously being able to accommodate change without sacrificing product consistency. The four key components of successful biologics manufacturing are...


Quantitative Assessment of Environmental Impact of Biologics Manufacturing Using Process Mass Intensity Analysis.

Process mass intensity (PMI) is a benchmarking metric to evaluate the efficiency of a manufacturing process, which is indicative of the environmental impact of the process. Although this metric is commonly applied for small molecule manufacturing processes, it is less commonly applied to biologics. In this study, an Excel based tool developed by the ACS GCI Pharmaceutical Roundtable was used to calculate PMI of different manufacturing processes for a monoclonal antibody (mAb). For the upstream process, thre...

The US Biosimilar Market: Stunted Growth and Possible Reforms.

In 2010, Congress created an abbreviated application pathway for biosimilars, versions of approved biologics made by different manufacturers. However, as of November 1, 2018, the Food and Drug Administration had approved only 13 biosimilars under this pathway, of which just 6 were available for patients to use. We review the history of US regulation of biologics and identify manufacturing, regulatory, and marketing issues that have limited biosimilar market entry and uptake, concluding with recommendations ...


Introduction of a Process Mass Intensity Metric for Biologics.

Biopharmaceuticals (or biologics), large molecule therapeutics typically produced using biotechnology, are a rapidly growing segment of the pharmaceutical market. As such, the environmental footprint of the production of these molecules is coming under scrutiny from various stakeholders such as healthcare providers, investors, and even employees. Process mass intensity (PMI), originally adopted for small molecules by the Green Chemistry Institute Pharmaceutical Roundtable, is a simple metric that can also b...

Distinct genes and pathways associated with transcriptome differences in early cardiac development between fast- and slow-growing broilers.

Modern fast-growing broilers are susceptible to cardiac dysfunctions because their relatively small hearts cannot adequately meet the increased need of pumping blood through a large body mass. To improve cardiac health in broilers through breeding, we need to identify the genes and pathways that contribute to imbalanced cardiac development and occurrence of heart dysfunction. Two broiler lines-Ross 708 and Illinois-were included in this study as models of modern fast-growing and heritage slow-growing broile...

Associations between multiple immunosuppressive treatments before surgery and surgical morbidity in patients with ulcerative colitis during the era of biologics.

It is unclear whether immunomodulators or biologics, with the exception of corticosteroids, can be risk factors for postoperative infectious complications of ulcerative colitis (UC). Moreover, many immunosuppressive therapies including some biologics are used mainly to treat UC, and many patients are on multi-agent immunosuppressive therapy at the time of surgery. Therefore, we evaluated the influence of pre-operative multiple immunosuppressive agents on the occurrence of surgical site infection (SSI) in UC...

Considerations for implementing an informatics system to support biologics drug discovery.

A comprehensive, well-functioning and scientifically aware informatics environment is of the utmost importance in supporting effective drug discovery programs. However, implementing such a system can, without a carefully crafted and enacted strategy, be a disruptive and time-consuming process, fraught with risks of cost overruns and the potential to end up with a system that ultimately does not meet the ever-evolving needs of the organization. In this review, using our experience from the software provider ...

Use of Population Pharmacokinetic Analyses Among FDA-Approved Biologics.

Biologics, especially monoclonal antibodies, are increasingly important in the pharmaceutical marketplace. Population pharmacokinetic (PK) analyses could be useful to guide the need for dose adjustments among special populations, yet it is unknown how commonly such analyses are performed during biologics development. We summarized the characteristics of population PK models of biologics and examined their role in informing the drug labels. To do so, we extracted relevant characteristics of 86 biologics appr...

Advanced formulations for Intranasal Delivery of Biologics.

The global biologics market has been ever increasing over the last decades and is predicted to top Euro 350 by 2020. Facing this scenario, the parenteral route of biologics administration as hitherto standard route is inconvenient for the future. Among the alternatives, the intranasal delivery of therapeutic biologicals seems to be most promising but researchers are still facing challenges as indicated by the scarce number of successfully marketed peptide drugs.

Advancing Professionalization of Biobank Business Operations: A Worldwide Survey.

Quality specimens from biobanks are key resources to support reproducible research. Sustaining biobanks requires robust management. We recently published a pilot survey that indicated that over half the participating biobanks had business plans in place and another third were working on business planning. While the results provided a clue to the status of business planning in biobanking, it was concluded that a longer and more in-depth survey and analysis were required. In April 2017, an extended survey was...

Transcriptome profile analysis of leg muscle tissues between slow- and fast-growing chickens.

Chicken is widely favored by consumers because of some unique features. The leg muscles occupy an important position in the market. However, the specific mechanism for regulating muscle growth speed is not clear. In this experiment, we used Jinghai yellow chickens with different body weights at 300 days as research subjects. The chickens were divided into fast- and slow-growing groups, and we collected leg muscles after slaughtering for use in RNA-seq. After comparing the two groups, 87 differentially expre...

Progression of continuous downstream processing of monoclonal antibodies: current trends and challenges.

Rapid advances in intensifying upstream processes for biologics production have left downstream processing as a bottleneck in the manufacturing scheme. Biomanufacturers are pursuing continuous downstream process development to increase efficiency and flexibility, reduce footprint and cost of goods and improve product consistency and quality. Even after successful laboratory trials, the implementation of a continuous process at manufacturing scale is not easy to achieve. This paper reviews specific challenge...

Dose Increase beyond Labelled Dose of Biologics Is Associated With Incremental Pharmacy Costs: Results from a Real-World Study In the UK.

Evidence regarding dosing patterns of biologics among moderate to severe psoriasis patients and impact on costs in the United Kingdom (UK) is limited.

Exploring the business of urology: Is it time for a "Business of Healthcare" curriculum in urology residency programs?

Dosing considerations for inhaled biologics.

The number of biologics in the therapeutic development pipeline is increasing including those delivered though inhalation (Morales, 2017; Fathe, 2016). Biologics comprise a broad variety of complex macromolecules with unique physicochemical characteristics. These distinctive characteristics control their pharmacological mechanisms of action, stability, and ultimately affect their processing, formulation, and delivery requirements. This review systematically covers crucial aspects of biologic powders formula...

Adherence and resource use among psoriasis patients treated with biologics.

The emergence of immune-modulating drugs such as biologics has altered the treatment landscape for psoriasis. However, their use presents high financial costs to patients and healthcare systems. Patient demographic and socioeconomic status may influence adherence to biologic medications and usage of healthcare resources. Areas covered: We performed a systematic literature review to summarize the available evidence pertaining to biologic medication adherence and resource use. PubMed was searched using the te...

Why Biologics and Biosimilars Remain So Expensive: Despite Two Wins for Biosimilars, the Supreme Court's Recent Rulings do not Solve Fundamental Barriers to Competition.

Biologics and biosimilars are medicines made from living cells that treat common and serious diseases such as cancer, diabetes, rheumatoid arthritis, and other inflammatory diseases. They are highly targeted, efficacious, and represent an increasingly important part of physicians' armamentaria in the combat against these medical conditions. Yet they are extremely expensive, costing on average $10,000-$30,000 per year and exceed $500,000 for the most expensive biologics. The advent of biosimilar drugs, or hi...

Evaluation of U.S. Manufacturing Subsectors at Risk of Physical Water Shortages.

The potential impact of water shortages on U.S. manufacturing is unknown. While water for manufacturing constitutes an estimated 6% of U.S. water intake, the data (i.e. location, quantity, and purpose of water intake) needed to determine this impact does not exist. This paper will identify manufacturing subsectors at risk of physical water shortages by applying a method for estimating U.S. manufacturing water intake at the necessary spatial and sectoral resolutions. First, the data requirements to quantify ...

M-CSF and IL-34 expression as indicators for growth in sporadic vestibular schwannoma.

Macrophage colony stimulating factor and IL-34 are associated with clinical vestibular schwannoma progression. Investigating the biology behind vestibular schwannoma progression helps understanding tumor growth. Inflammation is important in the microenvironment of neoplasms. Macrophages are major players in the intratumoral infiltrate. These tumor-associated macrophages are known to stimulate angiogenesis and cell growth. M-CSF and IL-34 are cytokines that can regulate tumor-infiltrating macrophages. They a...

Racial Differences in Perceptions of Psoriasis Therapies: Implications for Racial Disparities in Psoriasis Treatment.

In the U.S., black patients are less likely than whites to receive biologic treatment for their psoriasis. We conducted a qualitative freelisting study to identify patient-generated factors that may explain this apparent racial disparity in psoriasis treatment by comparing the perceptions of biologics and other psoriasis therapies between white and black adults with psoriasis. Participants included 68 white and black adults with moderate to severe psoriasis who had and had not received biologic treatment. E...

Why Medicare Advantage enrollment will keep on growing, whatever the politics.

In 2019, a record 36% of Medicare beneficiaries will be getting their benefits in a Medicare Advantage plan. CMS has broadened the services such plans can provide-services that may reduce expensive treatments and injuries. Insurers continue to see the market as a business opportunity. Critics see a slow-motion privatization of the entitlement.

In further defense of nonclinical abuse liability testing of biologics.

Risk assessment is not a choice. Drug Abuse Liability (DAL) is mandated under international and national drug control statutes for all drugs targeting the CNS. Once administered to humans many biologics may have long-lived or permanent physiological effects that make DAL testing arduous. We respond to premises of a recently published position on DAL testing of biologics by de Zafra et al. (2018). We propose that, at a minimum, Sponsors submitting a Biologics Licensure Application (BLA) must think "outside t...

Business performance management in university hospitals: a diagnosis in Brazilian institutions.

To investigate whether business performance management practices are used by Brazilian federal university hospitals, and if so, to determine which practices are used and explore characteristics that may be related to their adoption.

Biologics and immunoglobulins in the treatment of pyoderma gangrenosum - analysis of 52 patients.

Corticosteroids and cyclosporine A are frequently ineffective as first-line therapies in the treatment of pyoderma gangrenosum (PG) and associated with a number of adverse effects. The objective of the present study was to analyze the effectiveness and safety of biologics and intravenous immunoglobulins (IVIGs).

Biologics and Small Molecule Agents in Allergic and Immunologic Skin Diseases.

Biologics and small molecules are key therapeutic options in the treatment of chronic immunologic and allergic skin conditions. By directly targeting innate and inflammatory responses within the skin, including pro-inflammatory cytokines and cellular signaling pathways, these new agents have the potential to counteract the inflammatory cascade responsible for various conditions, including psoriasis and atopic dermatitis. Over the past decade, groundbreaking research identifying key cytokines and receptors i...


Advertisement
Quick Search
Advertisement
Advertisement