Pharma Manufacturing practices include all methods that are required to develop Pharma services. These practices provide minimum requirements that must and should be met by pharmaceutical companies in order to provide high-quality products that will pose no risk to the patients/consumers at large. Pharmaceutical contract manufacturing process involves Pharmaceutical machinery, drug manufacturers contracting a firm for finished products or components. It can be seen as a type of outsourcing. Organizations succeed by focusing on what they do best to their consumers, partners or outsourced vendors. Contract manufacturing seems to fit neatly into this scenario.
All protein biotherapeutics are potentially immunogenic and hence could elicit immunogenicity response These responses could be of different types such as binding antibodies or neutralising antibodies Immunogenicity of protein biotherapeutics is a major concern especially when the biological functio..
In recent history Multinational Corporations MNCs from all industries have established their own production systems based on Toyotas unique success story Nevertheless industrial companies are still facing issues when it comes to the quantification of the influence of single system elements on the co..
Most firms in the pharmaceutical industry think globally to expand demand for their products There are amenities from which firms leverage to launch a strategy to gain global market share These amenities include the regulatory dimension which helps reassign resources within and outside the firm..
The inherent risk in establishing biopharmaceutical production product process timeline capacity regulatory and location can be significantly mitigated by using a modular and standardised approach Utilising a combination of standardisation modularisation and use of modern process solutions such as s..
Antibody Drug Conjugates provide a high level of promise and hence there will be a conscious effort to expand the applications of this technology to disease indications beyond oncology provide a high level of promise and hence there will be a conscious effort to expand the applications of this techn..
The pharma industry can add value reduce costs and improve the overall quality of its products by improving packaging and labelling processes enabled by integrated Product Lifecycle Management solutions..
Processes of today are often equipped with sensors and measurement systems collecting large amount of data Chemometrics is developed to handle large amount of data for overview monitoring and relations between raw materials process parameters instruments and Critical Quality Attributes..
Modern process analytical technology systems generate continuous quality monitoring and provide plant process controllers with highly useful process information to increase the productivity and adhere to higher quality standards..
Many new approaches have been considered for largescale chromatography including membrane adsorbers The benefits and drawbacks of these devices and their potential impact on the biopharmaceutical industry are discussed..
Extensive adoption of singleuse products in manufacturing has shown considerable cost reductions by limiting initial capital costs utilities required and cleaning validation etc Do they promise the same benefits in the Asian manufacturing scenario where overall cost of production and labour are sign..