CMC Project Integration
Project support designed around your goals
We deliver the full spectrum of project integration support, all designed around your business needs and goals. We’ll work closely with you to:
- Coordinate the activities of an integrated CMC team
- Develop timelines and budgets for global regulatory dossiers
- Coordinate the activities of the sponsors, vendors, and consultants as subject matter experts
Why choose Alira Health for CMC Project Integration?
Our team of subject matter experts support the design and development of robust, scalable manufacturing processes. They provide:
- Coordinated, adept facilitation between clients and CDMOs
- Experienced project management with a focus on timelines and budget for multidisciplinary CMC teams, including clients and vendors
- Deep background in coordinating authors to create regulatory documentation for submission in line with critical timelines
- Tailored guidance on preparation of pre-IND, IND, IMPD and BLA filings
CMC Project Integration News
Therapeutic IgG-Like Bispecific Antibodies: Modular Versatility and Manufacturing Challenges
Our experts conducted a deep evaluation of IgG-like bsAbs including general advantages and disadvantages compared with MAbs and more.
Immunoglobulin Fc-Fusion Proteins
Our experts published a series of articles in BioProcess International reviewing the state of the art of Fc – fusion proteins, including their structure and molecular design, manufacturing(...)
Capture of CH1-Containing Bispecific Antibodies: Evaluating an Alternative to Protein A
In the article our team investigated the use of an alternative purification method for BsAbs – a commercially available CaptureSelect CH1-XL affinity resin.
The Process of CDMO Selection for Antibody Development: Matching Capabilities to Need
In this webinar, you'll learn how to identify key solution features, define patient experience expectations, generate evidence, and more!
Biotechs on the Rise
In the final article of our Biotech series, Joris Pezzini talks about the evolution of biotechs in the face of challenges and the drivers for future success.
Advances in Biologics and CGT
We are excited to share that we will be joining the Networking Reception: Advances in Biologics and CGT hosted by Catalent.
Essential Elements of Technology Transfer
Peter Alexander, Senior Consultant, CMC, co-authored an article about technology transfer categories, essential elements, and documentation.