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October 12, 2022 53Biologics Comments: 0

CMC Strategy for mRNA Manufacturing 

There is no question that mRNA mannufacturing is not easy. Besides testing their safety and efficacy, biopharmaceutical companies must also design a protocol for scaling and manufacturing the drug for regulatory approval and commercial use. This creates an immense pressure to expeditiously develop streamlined chemistry, manufacturing and control (CMC) strategies.  That is why in this article we will explain what a CMC strategy is and the challenges in the mRNA manufacturing.   What is CMC Deve...
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September 15, 2022 53Biologics Comments: 0

How to Improve Efficiency in Biopharmaceutical Process Development 

Process development landscape is changing and facing new challenges. Nowadays, time to clinic and time to market are becoming more important than ever for developers and manufacturers of biopharmaceuticals.   Although historically, the development timeline for a pharmaceutical drug has been 8 to 10 years, today with the use of expedited programs, such as fast track approval and breakthrough drug designation, has made the development time shrink.   In this article, we will speak about some in...
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August 29, 2022 53Biologics Comments: 0

Plasmid DNA Production for Cell and Gene Therapy – Q&A

In cell and gene therapy manufacturing, high-quality plasmid DNA is a key component. The demand of high-quality plasmid DNA has increased and this has led to the need to optimize the manufacturing and the quality required for use in the manufacture of therapeutics. However, the plasmid DNA (pDNA) manufacturing faces several challenges like: Its large size. The shear sensitivity. The high viscosity. The similarities between the pDNA and the impurities present during manufacturing. This makes impo...
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August 24, 2022 53Biologics Comments: 0

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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August 10, 2022 53Biologics Comments: 0

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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August 1, 2022 53Biologics Comments: 0

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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July 27, 2022 53Biologics Comments: 0

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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July 11, 2022 53Biologics Comments: 0

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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July 4, 2022 53Biologics Comments: 0

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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June 20, 2022 53Biologics Comments: 0

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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