Alira Health

Alira Health

CMC Solutions

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

Events April 20, 2024
Symposium on Advanced Wound Care Spring 2024
Research & Development Wound Healing
Webinars February 5, 2024
What Comes After the mRNA Vaccines?
In the third episode of VacciTalks, we’ll discuss these new alternatives to mRNA vaccines and the promise they hold.
Drug Development Vaccines
Scientific Articles November 20, 2023
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.
CMC
Scientific Articles November 20, 2023
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(...)
CMC
Scientific Articles November 14, 2023
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.
CMC Drug Development
Webinars October 18, 2023
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!
CDMO CMC
Articles October 16, 2023
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.
Biotech Drug Development
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