Getting to the clinic is a major milestone for biopharmaceutical companies. The drug development journey is long, expensive, resource straining, and risky due to high attrition rates. A large amount of data must be generated, collected, interpreted and correctly integrated for the First-in-Human (FIH)-enabling data package. When developing more complex formats such as bispecific antibodies, fusion and recombinant proteins, you are probably facing even tougher technical challenges which can lead to longer timelines. As a biopharmaceutical company, you also face…

Once the hard work of selecting a capable biologics CDMO partner is complete, what does it take to build a productive CDMO/sponsor relationship? When evaluating biologics CDMOs, technical capabilities are understandably the primary selection criteria. Once critical technical fit and capacity are known, cultural compatibility becomes an essential ingredient in making the working relationship fruitful. At Bionova Scientific, we’ve built a reputation as a scientifically strong CDMO with the latest tools and infrastructure. But since our early days, we have…

The COVID-19 pandemic has led to a rapid and wide-ranging search for therapeutics to protect against and treat the illness. Besides the vaccines and antivirals that have been developed against SARS-CoV-2, a number of mAbs have been given emergency use authorization (EUA) by the FDA. Unfortunately, the neutralizing effect of mAb therapeutics can be reduced or negated by the evolution of viral variants. For this reason, the expedited discovery and development of new mAbs with neutralizing activity selective for novel…

With the explosion of the large molecule (biologics) market, the industry has entered a new era of drug development. This growth — 10% to 15% each year — is being driven by monoclonal antibodies (mAbs), which are anticipated to have worldwide sales of over $240 billion by 2025. However, with this expanding market comes some considerable challenges for drug manufacturers due to the fragile nature and instability of these large, complex molecules. As compared to small molecules, large molecules generally…

Of the many lessons learned during the pandemic, one overriding realization was that utilization of the primary, single-location manufacturing site, although the simplest and potentially most cost-effective strategy, can have significant consequences to the availability of critical life-saving biologics and vaccines. This scenario not only applies to drug product but also to drug substance and the wide range of raw materials used throughout the manufacturing supply chain. Thus, the need for ongoing production from multiple drug substance (DS) and drug…

For all stages throughout the development, manufacturing and release of your biological product, Eurofins BioPharma Product Testing offers comprehensive, fully CGMP-compliant Viral Clearance Services. We have two dedicated clearance suites for extensive capacity and timely execution and reporting of your study results. And all of our assays are fully validated to meet ICH Q2 requirements. Why Choose Eurofins BioPharma Product Testing? We bring together leading experts in the industry with extensive scientific and regulatory experience. By supporting you from study…

Industry changes, such as shorter timelines and increased product complexity, can often introduce additional risks to the sterile fill/finish process, resulting in production delays, additional costs, and safety concerns. Additionally, the advent of personalized medicines brings challenges to manufacturing and supply chain structure, emphasizing the need for speed and flexibility. Join Eurofins BioPharma Product Testing and Vanrx (now part of Cytiva), for an in-depth discussion covering ways to eliminate human error and other associated risks when producing small batches of…

The pipeline for antibody–drug conjugates (ADCs) includes hundreds of candidates, with several expected to receive approval in the near future. As more commercial products reach the market, there is an acute need for CDMOs that understand how to execute late-stage studies to support a filing strategy. CDMOs with plans to support commercial-scale ADC manufacturing are setting up processes to handle challenging supply chains and investing in facilities and processes to ensure efficiency, quality and security. In this white paper, we…