Need for comprehensive technical knowledge
Product development
For a young and innovative company, complying with GxP guidelines can be a daunting task. However, ensuring compliance with legal and ethical requirements is essential for the successful development and approval of biopharmaceutical products.
At !LEVA, we have unparalleled expertise in the GMP compliant biopharmaceutical manufacturing and the skills to navigate you through this phase effectively. We can also accompany you during the preclinical and early clinical processes with their GLP and GCP requirements.
Although each project is unique in it´s nature, the development of biopharmaceuticals follows a staggered approach in compliance with regulatory guidelines, which provides a robust overall framework. Nonetheless, there is constant technical progress and depending on the innovative power and medical need of the asset, product development can be driven forward with quite some creativity – we draw on profound experience here.
At !LEVA, we have extensive expertise to support you in the following areas:
Target definition
R&D phase
Knowing what you are aiming for is crucial during the early phases of development already. It allows setting the course for a targeted product development and facilitates a fast and clear decision-making throughout the entire process.
Our R&D advice includes:
- Generation of Target Product Profiles (TPP)
- Preparation of product development plans
- Data review & support of lead candidate selection
Customized manufacturing support
CMC development & GMP compliant manufacturing
In addition to our own hands-on experience with cell line development and manufacturing of biologics, we have been collaborating with small and big contract development and manufacturing organizations (CDMOs) in Europe, USA, and within the Asia Pacific region for many years.
Different project phases have different requirements and while it may be important to have the product manufactured in a timely and cost-efficient manner for early proof of concept studies, the transferability to a GMP compliant manufacturing process as well as Cost-of-Goods become highly important afterwards.
As part of our CMC advisory, we therefore analyze the current development status and define a long-term goal together with you, followed by developing the best strategy to achieve goals in the most time- and cost-efficient way.
Our CMC advice includes:
- Request for proposal (RFP) generation & CDMO selection
- Management of CDMOs for API manufacturing & F&F
- Monitoring of cell line & upstream/downstream development to support process optimization
- Review of CMC documentation
- Advice of QA/QC requirements & development of an analytical strategy for product release
- CMC due diligence / clinical readiness
- Generation or review of IMPDs for clinical trial applications
- Supervision of tech transfer
Initial safety and efficacy testing
Preclinical safety & PoC studies
To minimize risk of failure during clinical development, testing drug candidates for their safety and efficacy in preclinical models is indispensable.
Our pre-clinical advice includes:
- Identification of relevant disease models for proof of concept (PoC) studies
- Advice on the requirement & design of relevant preclinical studies to demonstrate product safety
- Vendor selection & management
- Incorporation of study data into regulatory dossiers
FIRST-in-human studies
Early clinical development
Our clinical advice includes:
When we ask our partners about the motivation for their innovation, the answer we usually hear is: “I want to see if this invention can help patients suffering from […]”. And so do we. Within our network, we are collaborating with experienced clinicians who have supported us with their expertise in the design and supervision of clinical trials for many years.
At !LEVA, we have worked with small regional as well as large and globally operating CROs for clinical phase I/II studies, including healthy volunteers as well as hospitalized patients, spanning from Europe to the Asia Pacific region.
- Advice on the overall clinical development strategy
- Generation of the Investigator’s Brochure (IB) & other documents relevant for the Clinical Trial Authorization (CTA) submission package
- Generation of clinical study synopsis
- Request for proposal (RFP) generation, organization of bid defense meetings
- Selection & management of CROs
For further topics in this field please ask us – we may also be able to help or to refer you to someone within our network.