Top Factors Driving Advancements in Biotherapeutic Development 

Realizing the therapies of the future requires ongoing innovation and measurable advancements in biotherapeutic development. In this blog, we look at three essential ways that this is currently being achieved:  

  1. Faster assay timelines 
  1. Novel biotherapeutic technologies (i.e., revolutionization of plasma fractionation) 
  1. Creating scalable processes for industrial production 

A commitment to the highest levels of excellence in science, as well as prioritizing collaboration between our scientists and the clients that come to Prolytix for solutions to their challenges, are what make these advancements possible, promoting optimized results and leading to more successful outcomes. 

Accelerated Assay Timelines

When you think about fast assay timelines, the first factor you think of might not be people. However, the secret to achieving the fastest possible assay timelines is having the right team of experts on hand, each of whom are allocated to the right aspects of the process and ready to support you from start to finish. From strategic de novo assay design to completing known/planned assays, the right partner should be flexible enough to prioritize your project. That’s where both speed and quality of service go hand in hand. 

The key assay timeline questions to ask when choosing a biotherapeutic development partner are:

  • How soon can they start my project?  
  • Will they prioritize us, or push us to the back of the line and have us waiting for months?  

The larger your development partner, the higher the likelihood of both “wait your turn” delays and higher costs — with prioritization given to whoever is paying the most. 

Novel Biotherapeutic Technologies 

The same uncommon agility and swiftness that enables assay timeline acceleration also facilitates the time and attention needed for core problem solving. Even unprecedented issues — such as novel biotherapeutics present in unfamiliar, unconventional matrices — receive the devoted attention they deserve to enable scientific advancements. Our recent work helping a client revolutionize plasma fractionation is an excellent example: 

The Prolytix scientific team created a downstream process for a novel plasma fractionation technology which uses salt instead of ethanol to precipitate immune globulin (IgG). This new method promises faster processing (48-72 hours) and higher IgG yield (>90%) compared to the traditional Cohn process. This groundbreaking technology is poised to revolutionize the realm of plasma fractionation, offering substantial cost savings and significantly improved yields. 

Scalable Processes for Industrial Production

In working with this revolutionary new plasma fractionation technology, our task was not only to validate the novel process, but we also needed to ensure industrial production scalability. Here’s where speed, novel biotherapeutic technology, and scalable production intersect. These were the results of the new process: 

  • 75% IgG yield, compared to the initial cryo-poor plasma 
  • Yield gains of 5-10% over the standard method 
  • Only 8 process steps, achieving completion within 48 hours (a substantial advancement compared to the Cohn process, which takes 7-10 days)  

Where other development partners might have taken anywhere from 7-10 years, within a mere 18 months, Prolytix both successfully harnessed the new technology and developed an infinitely scalable process for industrial IVIG production that met all the necessary safety and purity standards. 

Propelling Your Science Forward 

Whether you’re seeking biotherapeutic development support for your small startup team or your medium to large venture capital backed company, every project deserves the same level of attention and commitment to timeliness. Ensuring you select a partner with the inherent flexibility and adaptability to identify and address your needs is paramount. 

With proven expertise in protein biochemistry and plasma fractionation, as well as unparalleled capabilities to address any challenges that complex protein matrices may present, you can rely on the team at Prolytix and our range of in-house tools and technologies — such as high-resolution mass spectrometry (HRMS) and GMP testing — to quantitatively assess the quality metrics of your biotherapeutics no matter what obstacles the starting matrix may present. 

As your committed partner, Prolytix delivers scientific excellence and tailored solutions to your projects in protein chemistry and biotherapeutics with a personalized and consultative approach. With more than three decades of experience, our team possesses the necessary expertise to recognize and address even the most challenging obstacles in large molecule drug development.  

Have a therapy that you’re ready to develop? We’d love to make your project our priority

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