Product & Process Development Capabilities
At Kymanox, our biopharmaceutical, medical device, and packaging experts establish and improve manufacturing processes guided by Quality by Design (QbD) principles. We integrate product and process development to create practical and speedy solutions.
Turnkey Product Development Support
Development means target product profiles, development pathways, business cases, Quality by Design (QbD) process guidance, prototypes, and so much more. Kymanox can help with all of this and more!Explore More
Manufacturing Process Support
We provide competitive intelligence, technology scouting, and manufacturing equipment design, evaluation, selection, qualification, and start-up. We also assist with CDMOs when you decide to outsource.Explore More
Patient-centric Products & Processes
Our holistic, risk-based approach ensures that patient-centric products are developed and manufactured using efficient, consistent and cost-effective processes that meet regulatory, safety, and quality requirements.Explore More
Scale-Up and Growth
We help with development of timelines, procedures, and protocols to ensure efficient manufacturing process development, including technology transfer, that results in smooth scale-up.Explore More
Meet our Product & Process Development Experts
Dr. Nick Schill, PhD
Markets That Benefit from Our Product & Process Development Solutions
The Kymanox Product & Process Development Difference
Kymanox offers a forward-thinking approach to the product development lifecycle, accessing both industry-leading technologies and disruptive innovations to position products for commercial success.
Our team applies Kymanox’s development toolkit of project management, development, and quality management tools that can be customized to the needs of your company and project to ensure efficient and “fit for purpose” solutions to meet your project objectives.
Our team's broad experience and integrated development approach ensures Right First Time products for unmet patient needs in accordance with US FDA, EU EMA, and rest of world regulatory requirements.
We offer unmatched experience and knowledge across pharmaceuticals, biologics, medical devices, combination products, and in vitro diagnostics, so we are equipped to tackle any project in these areas. Our Development leads serve as a central hub to leverage subject matter experts from across the organization.
Frequently Asked Product & Process Development Questions (FAQs)
How do you handle technology transfer when an onsite visit is not possible?
Traditionally, tech transfer has required a site visit, but occasionally this is not possible. This makes the tech transfer process more challenging, as it increases the risks on both the technology and business sides, but Kymanox has procedures in place to handle these situations. We request video walkthroughs of facilities and filming of critical processes and additional aspects such as important tips from operators at the sending site. Documentation review and a deeper understanding of the process at a very early stage become even more important. Additional meetings with the subject matter experts (SMEs) are typically needed to cover additional questions and ensure a smooth tech transfer process.
What is a Detailed Product and Process Descriptions (DPPD) and why do I need that?
Although the DPPD is not a mandatory document that is required by the FDA, it is an essential document for a successful tech transfer process. Our subject matter experts (SMEs) will work with you to document all process and product history. Everything is summarized in a detailed report, and this document covers everything from product specifications, process details, in-process checks, and critical equipment, to material and critical equipment vendors, tests done on materials and processes, and raw materials specifications. Many companies prefer to keep their DPPD up to date, as it is also a proven tool that supports training of new employees.
At what phase of the development process should I engage Kymanox and why?
Kymanox is ready and able to support you at any point during the development process, however, earlier is better! Changes to product design become exponentially more expensive and challenging as development progresses. Kymanox can provide expert review of your proposed development and regulatory strategy and make sure your project is set up for success. Whether your product is in early concept feasibility, preparing for a clinical trial, gearing up for commercialization, or anywhere between, Kymanox can provide scalable and phase-appropriate support solutions.
I recently selected a contract manufacturer for my product. Why involve Kymanox now?
Kymanox is uniquely positioned to represent our client’s interests and ensure your contract manufacturer is held accountable to maintain project budget and timelines. Access to the entire Kymanox network of subject matter experts (SMEs) provides our customers and their Contract Development and Manufacturing Organizations (CDMOs) with technical, quality, and regulatory strategy guidance to ensure the successful approval and launch of your product. Technical development programs commonly encounter unforeseen technical and supply chain issues, and many of these problems can be outside the scope of your development agreement with the CDMO. Kymanox can quickly deploy the appropriate experts to investigate the problem and provide efficient solutions to keep your project on schedule.
Read the Latest at Kymanox
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How the FDA Defines Combination Products
Is your product a combination product? Combination products are defined in 21 CFR 3.2(e) and more products than ever now fall into this category but many manufacturers are unaware of that fact nine types of combination products. The FDA identifies.Ta...