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Incentives and Challenges in Biosimilar Development

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A biosimilar is a biotherapeutic which is almost like an authorized product in relation to the ingredients used and has no significant differences in safety and efficacy. Biologics are much larger than a small molecule, more complex fundamentally and they are created in living cells, then removed and cleaned. In contrast, small molecule medicines are produced solely through chemical synthesis. According to a McKinsey report, the biosimilars market will be thrice its current size by 2020. It shows how these drugs can transform the healthcare industry. According to the Biosimilars Council report, biosimilars can potentially save costs by up to $250 billion in the coming decade.  Challenges in Biosimilar Development Pharma companies around the world face several challenges to cut patient costs. Some of the common challenges that biosimilar companies face in packaging and processing are the variability of large molecules and offering the FDA with enough proof of clini
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Stability Testing of Pharmaceutical Products

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The commercial and scientific success of a pharma product can only be ensured with the knowledge of the drug development process and the innumerable milestones and tasks that are essential to a complete development plan. To determine the potency, purity, and identity of these pharma products, stability testing is essential. The stability of pharma products is the capability of a formulation in a specific environment and remain within its physical, therapeutic, microbiological, chemical, and toxicological specification. The stability studies of pharma products ensure the upkeep of product efficacy, safety, and quality throughout their life. Stability Testing is a complex process because of the involvement of several factors such as the interaction between active ingredients and excipients, type of dosage form, the stability of active ingredients, and container used for packaging. Types of Stability Testing  There are three major types of stability testing carried
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Development of Upstream and Downstream Processing in Biopharmaceutical Manufacturing

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The biopharma industry depends on change to grow in an environment that instantaneously demands higher quality, lower costs, and higher productivity. In upstream process development , biological materials are either acquired from outside or injected and bred in culture, under regulated conditions, to produce products. On the other hand, in downstream process development , the products are collected, purified, tested, and packaged. Different forms of biopharmaceutical process development involve technicians to wisely control the environment in which the cells grow.  If the product is to be used as a drug, biomanufacturing experts must work in places where current Good Manufacturing Practices (cGMP) are followed strictly. The progress witnessed in the industry has been remarkable, but the refined exterior of bioprocessing hides an interior of despair that cries under the burden of current demands. The rise in production achieved previously have been a result of enha
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The Challenges in Analytical Method Development and Validation

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The Challenges in Analytical Method Development and Validation Manufacturing biologics is not an easy task as drug companies face several challenges while safeguarding patient safety and product quality. Analytical testing offers the data required to produce effective and safe drugs. The growth and validation of analytical methods is key to drug development. The biopharma industry has successfully reduced risk by adopting analytical platform technologies for monoclonal products, drug conjugates, and new molecules. Several methods such as FDA’s Quality-by-Design (QbD) initiative can have a positive impact on validation and analytical method development because the procedures are identified early in the development process. Challenges Associated with Analytical Method Development and Validation The challenges bio pharma companies face with analytical method development and validation are as follows: Often the timelines for developing a drug are tight. However, suf
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cGMP Manufacturing in Pharmaceutical Industry

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                             Medical and biopharmaceutical drugs impact every individual and the regulatory authorities such as the Food and Drug Administration (FDA) enforce strict guidelines carefully. The governing standard for human consumption that ensures production of drugs of the highest quality is known as Current Good Manufacturing Practice ( CGMp Manufacturing ). Current Good Manufacturing Practice is an integral aspect of the pharmaceutical industry. By following this practice, each batch of drugs for humans will meet the set standards. Often people are unaware of CGMPs, or how the drug authority assures that drug production fulfil these elementary objectives. Of late, FDA announced several regulatory actions against drug companies based on the limited number of CGMPs.  What Do CGMPs Have to Offer? CGMPs assure proper monitoring, design, and control in the facilities and manufacturing processes. Strictly following the CGMP guidelines assures purity, quali
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Location: United States
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What Are The Benefits Of Pharmaceutical Contract Manufacturing?

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Biopharmaceutical Contract Manufacturing Organizations (CMOs) provide biopharma companies the choice to improve process efficiencies and prioritize their capacities. These companies offer services to biotechnology and pharma companies from product development to the final production of the product. Certain CMOs offer extraordinary end-to-end biologics capabilities with the world’s most advanced production facilities. The services offered by leading biologics provide the following expertise: Validation cGMP manufacturing Analytical characterization Fermentation biotechnology Process optimization Cell line development. CMOs can be hired to carry out small work as well as the large production work such as the manufacturing of the liquid and solid dosage forms. CMOs have played a major role in the biopharma industry’s growth for a long time, but it is only in the past couple of decades that they have become a vital element in the operations of bio/pharmaceutical
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Location: United States
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A Complete Guide to Biopharmaceutical Process Development & Manufacturing

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A biopharmaceutical is a medicinal product extracted or manufactured using biological sources. Biologics are often referred to as products manufactured using recombinant DNA technology. Biosimilars, on the other hand, are drugs that have been approved. Biopharmaceutical manufacturing has changed drastically over the last few decades.       Major changes have been witnessed in single-use technology whose advantages include reduced resources for cleaning and cleaning validation, better flexibility, and faster turnaround between products and batches, resulting in increased speed to market and reduced capital costs.  Biopharmaceutical process development and manufacturing focuses on the development and the practices and process approaches in providing regulated and cost-effective manufacturing of biologics in a timely manner that fulfil their intended use. Good manufacturing practices ensure that manufacturers constantly produce drugs to fulfil the purity, strength,
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Location: United States
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