Biologics & Cell and Gene Therapy Services
Kymanox gives you peace of mind by providing technical experience to make your biologics, cell and gene therapy, or vaccine product a success.
Development & Operations
Quality, Regulatory, & Compliance
Commissioning, Qualification, & Validation
Strategy, Planning, & Execution
Biologics & Cell and Gene Therapy Products & Services Where We Excel
Extracted from living systems
Extracted from Living Systems
Extracted from Living Systems
- • Whole blood and other blood components
- • Stem-cell therapy
- • Antibodies for passive immunity
Produced by Recombinant DNA
Produced by Recombinant DNA
- • Key signaling proteins (nearly) identical to those found in the body
- • Monoclonal antibodies
- • Receptor constructs (fusion proteins)
Vaccines
Vaccines
- • Viral (live or inactivated)
- • Viral vector
- • Subunit (protein or polysaccharide)
- • Nucleic acid (DNA or RNA)
Cell and Gene Therapy
Cell & Gene Therapies
- • Process Development
- • Clinical Trial Material (CTM) Oversight and Planning
- • Packaging Technology and Engineering
- • Regulatory Filings
Contract Development & Manufacturing Organizations (CDMO)
CDMO
- • Evaluation & Selection
- • Management
- • Tech Transfer
Kymanox Biologics & Cell and Gene Therapy Resources
Meet our Biologics Experts
Nick Schill, PhD
SENIOR DIRECTOR, PRODUCT DEVELOPMENT
Frequently Asked Biologic Questions (FAQs)
Can I just outsource this work to Kymanox?
In short, yes. Kymanox has a flexible approach with our clients that is based on the unique needs of that particular situation. In some situations we basically act as employees of our clients, effectively acting as a functional department within their company. You can’t tell a Kymanox employee apart from our clients in these situations. We have additional options to meet your needs for cell and gene therapy as well. One advantage to the Kymanox approach is that we empower our team of full-time employees and contractors with access to our entire team of experts, so when you hire Kymanox, you get the benefit of our collective experience. We invite you to learn more about our Staffing Solutions.
I have a pretty big project. Can Kymanox handle it?
Kymanox has extensive experience on multi-million dollar projects at some of the largest pharmaceutical, biologics, and medical device companies in the world. Our processes were built with the ability to scale to meet the needs of a virtual biotech startup, the largest of big pharma, and everything in between. One key to our success is our Program & Project Management team, our secret weapon in making sure we stay on track with our agreed upon scope and keeping clients informed so they can rest easy knowing there will be no surprises. Our approach is flexible, so you’ll get just the right amount of project management for your cell and gene therapy needs.
What is Ideal Knowledge Transfer™?
Ideal Knowledge Transfer™ (IKT™) is a continuously improving concept that seeks to address the knowledge transfer process in a formal and structured way where end-goal success can be predicted and measured. IKT™ builds on existing principles and disciplines, such as professional project management, fundamental engineering practices, universally recognized quality systems, and formal problem solving methods.
Leveraging our corporate DNA of IKT™, our talented team partners with global clients to facilitate development and delivery of products with optimized safety, quality, efficacy, accessibility, and efficiency. To learn more about IKT™ please visit our IKT blog post.
Read the Latest at Kymanox
The Factor Podcast: Navigating the Real-World Environment of Medical Products
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. In this episode, Rita Lin and Shannon Hoste share their experiences and journeys in the field of human factors engineering. Rita begins by recounting her path into hea...
The Factor Podcast: Factors to Consider in Support of Clinical Readiness
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. How do you know your combination product is ready for clinical trials? Will it pass the regulatory review for clinical approval to proceed? The complexities of har...
The Factor Podcast: The Role of Human Factors in Medical Product Development
The Factor is a global medical device podcast series sponsored by Agilis by Kymanox. In this episode, Shannon Hoste and Rita Lin delve into the importance of real-world evidence, collaboration, and education within the medical device and combinatio...