Services

Analytical and Process Development: See the Whole Picture

Analytical and Process Development Services by K2bio: Precision and Innovation for Your Scientific Journey

At K2bio, we recognize the pivotal role that analytical and process development play in the journey from discovery to commercialization. Our comprehensive suite of services is designed to empower researchers, biotech companies, and pharmaceutical organizations with the tools needed to navigate the complexities of drug development and biomanufacturing.

We are here to provide our clients with the exact assay based on the stage of development, ranging from a qualified method to a fully validated assay. We offer our clients cutting edge scientific services with a focus on assay development for cell and gene therapy including flow cytometry, LC-MS/MS, ddPCR, spatial in situ and several other platforms to provide meaningful and accurate data.

In addition, K2bio brings more than 2 decades of combined experience in developing and optimizing manufacturing processes for cell and gene therapy delivery methods utilizing viral and nonviral techniques. We guide you through the product lifecycle from early discovery through Tech Transfer for clinical phase manufacturing.

Our Analytical and Process Development Service Offerings:

Analytical Method Development:
Our team of analytical experts specializes in the development of analytical methods. Whether it’s for early discovery, in vitro and in vivo mechanism of action, product release or extended product characterization, we tailor our phase appropriate approach to method development to achieve your specific needs.

Cutting-Edge Technology:
We stay at the forefront of scientific innovation, regularly updating our equipment and methodologies to provide you with the latest advancements in in vitro research.

Process Characterization:
Process characterization is an important strategy in the drug development life cycle to identify process parameters and product quality attributes. K2’s experienced team can perform in-process and final drug product testing to help establish a Quality Target Profile (QTP) and acceptable operating ranges to meet regulatory requirements and industry standards.

Process Optimization:
Maximize efficiency and yield while minimizing production costs with our process optimization services. We work closely with you to fine-tune and scale up your process, ensuring seamless transitions from lab to pilot-scale and beyond.

Tech Transfer Support:
Facilitate transfer of your process from development to manufacturing with our tech transfer expertise. We offer documentation, training, and on-site support to ensure successful transitions.

Why Choose K2bio for Analytical and Process Development:

Scientific Excellence: Our team of dedicated scientists and engineers brings a wealth of experience and expertise to each project, delivering actionable insight and reliable data.

Advanced Instrumentation: We invest in state-of-the-art analytical instruments and technologies to provide you with the highest level of data quality.

Customized Solutions: We understand that each project is unique, and we work closely with you to develop tailored solutions that address your specific challenges and objectives.

Regulatory Expertise: We are well-versed in regulatory guidelines and requirements, ensuring that your projects are conducted with compliance in mind from start to finish.

Collaborative Approach: We view our clients as partners and work collaboratively to achieve your goals, providing transparent communication and project updates.

Elevate your scientific endeavors with K2bio's analytical and process development services.

Ready to discuss the personalized services offered by K2bio?