Alava consultants have experience working for the top product developers, so we understand industry best practices and regulatory expectations. For antibodies and recombinant proteins using typical expression systems, we will develop a streamlined and low-risk CMC program to achieve your goals with the best possible speed and value. For biosimilars, we will help you navigate the connections between process and product characteristics, and develop a winning comparability strategy.
We also have a record of success in pioneering the technologies that will lead to the blockbuster products of tomorrow. Novel products and technologies require creative problem-solving and experience in overcoming CMC-regulatory challenges, while working with a narrower pool of suppliers.
Products and Technologies
- Antibodies
- Cell and Gene Therapies
Alava’s consultants helped pioneer the groundbreaking technologies that are now an important part of medical practice, and are now helping our clients develop the potential of next generation technologies such as iPSC derived cell therapies, gene editing and mRNA.
Alava’s project list includes multiple CIRM-funded cell therapy projects and diligence on inlicensing and acquisition opportunities for multiple investors and top biopharms. Alava team members have strong experience working with academic/medical centers, navigating the Quality expectations for novel therapies, and managing the scale-out issues connected with autologous therapies. Our deep experience with viral-based manufacturing includes decades of experience with the vaccine, plasmid and vector platforms that are now the foundation of gene therapy design and manufacturing. In recent years we have supported numerous projects based on AAV, adenovirus, lentivirus, and multiple oncolytic virus platforms.
- Antibody-drug conjugates
- Small molecule (oral, injectable)
- Biosimilars
- Vaccines (viral, bacterial, recombinant)
- Fab fragments and fusion proteins
- Recombinant proteins (E. coli, yeast, bacteria)