At Lindville Bio, we help clients develop a clear roadmap for efficient
iPSC/hESC therapy translation. Our team offers strategic advice on the following areas:
We provide strategic advice on process development, considering the indication and shape of the final therapeutic product from the beginning, ensuring quality, scalability, and flexibility
We provide guidance on the identification and selection of suitable donor material for therapeutic development and offer donor consent services
Our team offers guidance on sourcing suitable lines for the desired indication and population, identifying lines under clinical and commercial licenses
Our regulatory affairs and approval services help clients navigate the regulatory landscape and meet the requirements of different jurisdictions, preparing GMP documentation for regulators
We provide intellectual property review and licensing services for research, clinical and commercial purposes, helping clients to gain the freedom to operate and understand how that affects the translation strategy
Our team provides global resource and market analysis services, helping clients understand the demand for iPSC/hESC therapies, investment trends, and selecting the best market and indication for their product
We offer guidance on human leukocyte antigens (HLA) matching and immunomodulation for allogeneic therapies
We help to understand the consequences of the final therapeutic format from the beginning, and provides guidance on the level of expertise required to administer the therapeutic product and how it contributes to the clinical impact
We provide guidance on Supply Chain Assessment,
Supplier Assessment & Redundancy Integration and
Critical Logistic Attributes
We provide investors with in-depth evaluations of companies' scientific, clinical, manufacturing, business, and promotion strategies to inform and maximize successful investments