The bioanalytical services industry is booming. Pharmaceutical and biotech companies, large and small, have realized that dedicated contract development and manufacturing organizations (CDMOs) can be essential outsourcing partners in the expensive and arduous drug discovery and evaluation process.
As costs rise, and funding gets harder to secure, more therapeutics companies may have to decide against building their own manufacturing facilities, and instead, rely increasingly frequently on CDMOs for their manufacturing needs.
However, it’s worth noting that analytical development and testing go hand in hand with manufacturing when it comes to releasing a product for clinical trials or commercial use. In the complex biologics landscape, partnering with an integrated organization that functions as both a contract research organization (CRO) and CDMO, and who can fulfill all your manufacturing and analytical development requirements under the same roof can be a huge advantage.
Knowing and Fulfilling Your Bioanalytical Needs
Knowing which services you need is half the battle, and that will vary depending on where you are in your pipeline development. Bioanalytical services are vital in every step of the way, whether you are just starting with a discovery concept or are in the final steps to approval.
Continual evaluation and refinement at points along the entire pipeline are the essence of bioanalysis. For these reasons, choosing the right partner is obviously critical.
Choosing a Bioanalytical Services Partner
Bioanalytical services are more than just running a test. Your analytics partner should be able to advise you with certainty on whether you need flow cytometry or spectral flow cytometry, on the details of the U.S. FDA bioanalytical method guidance, but also those of the EMA and other global regulatory bodies. They should be able to tell just how many validation methods are required to confirm product stability, and how to ensure that your analytical methodologies are phase appropriate so that you don’t over-invest unnecessarily in early development, but have everything you need ready for later stages.
Process and technique go hand in hand. Using the right tool at the right time is another way of looking at it, and in a dynamic market with an evolving regulatory landscape, choosing a partner who can help you navigate the journey from preclinical and investigational new drug (IND) discovery, through clinical trial support of promising candidates to chemistry, manufacturing, and controls (CMC) production evaluation, is key.
Biologics Testing Requirements for Preclinical Studies
Validating the promise in preclinical requires a host of assay procedures. Toxicokinetic (TK) studies should be done in the form of bioanalytical sampling to determine the effect of your drug substance in the body over time, and how this changes with dose. Cell-based potency assays measure the biological response of a product in a particular biological system. And comprehensive immune profiling using flow cytometry technology identifies cell phenotype at single cell level and explores immune system function.
Testing and Assays for Clinical Trials
When a candidate substance graduates to human clinical trial status, this is when the need for phase appropriately qualified analytical methods comes in, and additional safety assays like sterility, bioburden and endotoxin assays are required. Regulatory filings require the strictest data documentation and knowing that your chosen partner can leverage their own tried and tested proprietary assays on your behalf, as well as developing new custom assays tailored to your product and designed to pass rigorous regulatory scrutiny, can be immensely reassuring.
CMC Analytical Testing
The development and manufacture of new pharmaceutical products are defined by cGMP compliance and product specific quality attributes governed by CMC protocols. There is, however, “phase-appropriate” leeway in regulatory compliance designed to make early development easier, and a partner who understands this spectrum of compliance for cGMP lot release testing and product stability testing, which can be something of an art form, is invaluable.
Bioanalytical Expertise and More
At Scorpius BioManufacturing — located in San Antonio, in the heart of Texas — our bioanalytical capabilities and bioassay evaluations support all stages of product development.
Our fully integrated bioanalytical services are carefully designed to meet the complex and diverse bioanalysis needs of our pharmaceutical and biotech clients. Flexibility of design and configuration in our brand-new clinical facility allows us to be a nimble outsourcing partner, collaborating with our clients on the full product lifecycle, from preclinical to commercial-scale cGMP production.
Equally adept at working for large and small clients, our seasoned staff can develop and implement the custom analytical testing requirements necessary for your candidate products through all stages of the pipeline. Our experienced team understands the rigors of discovery process and analysis, and a concerted emphasis on a secure domestic supply chain and the use of American-made equipment and reagents also ensures a solid operational foundation.
This end-to-end agility and stability advantageously position us in the biomanufacturing arena. As an experienced, flexible, integrated CDMO and CRO, Scorpius BioManufacturing welcomes the challenge of your drug discovery and development needs. To find out more about how we can help you contact us today.