Worldwide Clinical Trials expanded its Early Phase large molecule capabilities and services with a new 15,000 square-foot dedicated lab at its multimillion-dollar Bioanalytical Center of Excellence in Austin, Texas.
The global large molecule bioanalytical testing services market was valued at USD 1.4 billion in 2020 and is expected to experience a compound annual growth rate (CAGR) of 9.5% until 2028 (source). Driving this growth are increasingly complex innovations in the healthcare sector, causing the demand for quality and technologically advanced large molecule bioanalytical testing services to expand at a rapid rate. However, there are challenges in the current marketplace to address the increasing demand.
With its new large molecule dedicated lab, Worldwide is positioned to meet this demand with a forecasted sample analysis scale of about 70,000 annually, increasing to about 200,000 in 2024, across pharmacokinetic (PK), anti-drug antibodies (ADA), and biomarkers. Beyond assay transfer and validation, the scientific team develops assays for popular large molecule drug modalities, such as monoclonal antibodies (mAb), bispecific, antibody-drug conjugates (ADC), fusion protein, and more.
The added capacity enables Worldwide to provide its sponsors with optimized sample processing and analysis workflows for minimal turnaround times, as well as the flexibility to continuously scale additional capabilities into preexisting workflows – all while supporting a clinical trial landscape with increasingly complex study permutations. Through Worldwide’s scientific and technical consultation and services, plus access to industry-leading experts, sponsors experience improved data delivery and the ability to make informed decisions, faster.
“We are excited to expand our services to meet the rapid increase in large molecule demands and to better support our sponsors’ unique needs – giving them a competitive advantage to face the bioanalytical revolution head-on,” said Mike Mencer, Executive Vice President and General Manager, Early Phase, Worldwide. “Our expanded capacity is vital to the development of large molecule products, such as vaccines, blood products, and gene and cellular therapies for patients.”
Led by bioanalysis expert Dr. Tom Zhang, Worldwide’s large molecule capabilities are integrated seamlessly into its preexisting clinical pharmacology and pharmacokinetics business unit. Capabilities include pharmacodynamic studies, pharmacokinetics, biomarker assays, genotyping, and immunogenicity testing, which will materially facilitate translational research efforts unique to a variety of therapeutic modalities.
Ahead of this expansion, Worldwide has built on the company’s commitment to support preclinical and early phase research with several developments and investments. Earlier this year, the organization announced the opening of its 42,000 square foot state-of-the-art lab in Austin, as well as key additions to its Early Phase team to enhance its capabilities in bioanalytical testing for large and small molecule processing. The new lab, strategically located near Worldwide’s Clinical Pharmacology Unit, has played a critical role in exceeding the needs of sponsors to conduct top-quality early phase study research for normal and specialized patient populations.
Subscribe to our e-Newsletters
Stay up to date with the latest news, articles, and events. Plus, get special
offers from Pharmaceutical Outsourcing – all delivered right to your inbox! Sign up now!