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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
Pitfalls to Avoid When You are Seeking a CDMO With increasingly specialized science and technology, keeping biologics and drug development and manufacturing in-house is not feasible. Selecting a Contract Development and Manufacturing Organization (CDMO) partner is more necessary than ever. But not every CDMO is the best choice for your company. Selecting a Contract [...]
