The OLIGOFASTX project has launched his website

In the research world it is essential to share the achievements that are being made, not only with the rest of the research community, but also with the general public. The recent launched Oligofastx website makes this task easier by making available to everyone the latest news of the project. But let’s start from the beginning… What is the Oligosfastx project? The Oligofastx project aims to create a comprehensive platform to contribute to the development of oligonucleotide-based therap...
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Manufacturing Strategies for mRNA Vaccines and Therapeutics

The swift delivery of the world’s first COVID-19 vaccine put a big spotlight on the promise of mRNA technology. mRNA technology uses non-viral systems and offers a great deal of versatility. Administration of an mRNA into the cytosol of a cell can induce the production of a target protein which can function as an antigen to trigger an immune response for vaccination purposes, replace a defective protein or activate an anti-tumor response. In this article, we will discuss the mRNA manufacturing...
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Consider cGMP to Minimize the Risks and Accelerate Your Development Milestones

Current good manufacturing practices (cGMP) are central to drug manufacturing, helping to produce chemicals and other raw materials in accordance with specific controls and quality systems. The development of pharma and biopharma products requires materials as well as the expertise on how to use them. Despite what cGMP stand for in terms of drug quality and consistency, studies indicate that only half of biopharmaceutical developers use cGMP chemicals in early-stage clinical trials. In this arti...
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Accelerating mAb Development

Monoclonal antibody biotherapeutics account for roughly one-fifth of FDA new drug approvals every year, with cancer treatments accounting for the majority of them. Beside the full-length monoclonal antibodies, researchers are also looking at next-generation antibody products, including antibody drug conjugates (ADCs), antibody fragments, antibody-like proteins, engineered antibodies and others. Moreover, there is also a marked focus on the biosimilar market, which is currently worth roughly $4.3...
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The answer to the Top 7 Questions about Biologics Development and Manufacturing

The biologics market represents the leading of novel therapeutics. With advancements in DNA technology and increasing investments in personalized medicine, growing rate is even twice the growth rate of small molecule therapeutics. In this article, we will answer to the 7 top questions about biologics development and manufacturing. 1. Which are the differences in the development between biologics and small molecule drug products? The most significant difference between biologics and small molecul...
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Clinical Manufacturing – How It Works

The drug development process includes these five stages: Discovery and Development Preclinical Research Clinical Research Regulatory Agency Review Regulatory Agency Post-Market Safety Monitoring Clinical research is the third stage of the drug development process and drugs that are being tested and researched in this stage of the process are not usually manufactured the same way or in the same facilities as drugs that are in commercial production. In this article, we’ll discuss the basics of c...
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Top Considerations for Tech Transfer Performance

A top priority for drug developers is to find outsourcing partners with experience in transferring and scaling their product formulation and processes from sending unit (SU) to commercial-scale receiving unit (RU) in compliance with regulatory agencies. Whether you are a new drug developer or a veteran, there are four key considerations you should consider when you search for a CDMO partner for a strong technology transfer performance. 1. Geography An understanding of the market landscape is n...
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Quality By Design in Biologic Drug Development

As the biopharmaceutical industry continues to evolve and in response to increased interest from global regulatory agencies, the Quality by Design (QbD) integrated and proactive approach to drug development and manufacturing is transforming key processes. QbD seeks to further reduce the risk associated with drug development and bring much-needed therapies to market quicker. As an example,  companies that implement QbD early can save money through increased product/process knowledge, less re-w...
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Monoclonal Antibody Manufacturing in Biopharma Companies

A company’s strategy is crucial for determining future success, and therefore, it needs to constantly change in line with market dynamics. Today, mAbs represent the dominant product class within biopharmaceuticals, driven largely by the increasing prevalence of – and increasingly sophisticated approaches to treating – severe and complex diseases, including cancers. Additionally, in 2020, 55% of biologics reached the clinical stage (628 of 1133), with 426 products related to mAbs. According...
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What is the Difference Between Master Cell Bank and Working Cell Bank?

Getting to market first starts with cell banking as the foundation for your biologics production. Cell banks should be used when cell lines are used in the biologics production. Particularly in case that your protein of interest will follow clinical studies, regulatory agencies require cell bank manufacturers to guarantee continued stability and safety of cell lines producing biologics under cGMP. Why is cell banking important? Cell banking provides a characterized, common starting source for ea...
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