CMC Solutions

CMC Manufacturing Strategy and Operations

CMC Manufacturing Strategies that Succeed

We provide strategic guidance on the stages and costs of biopharmaceutical drug development including potency methods, such as binding assays and bioassays.

Our full spectrum of strategy and operations support features solutions tailored to your business. Our dedicated team can:
  • Develop budget and timeline estimates for preclinical development
  • Design preclinical proof-of-concept studies
  • Create manufacturing processes and oversee implementation
  • Support assay development and qualification
  • Plan and oversee execution of formulation development and stability
  • Manage reference standard preparation
  • Oversee production of toxicology and cGMP lots
  • Plan and execute GLP toxicology studies

Why Choose Alira Health for CMC Manufacturing?

From engagement to product launch, you can rely on a dedicated Alira Health team to support the full spectrum of your drug development needs:

  • Knowledgeable industry experts who deliver scalable, actionable insights
  • Commitment to client advocacy with vendors to drive holistic solutions tailored to your business needs and goals
  • Focus on identification and execution of phase-appropriate clinical development activities
  • Strategic technical guidance, risk management, and evaluation of costs for clinical and commercial manufacturing development processes

CMC Manufacturing News

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
Multimedia 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
Events September 27, 2023
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.
Biologics CMC
Scientific Articles September 21, 2023
Essential Elements of Technology Transfer
Peter Alexander, Senior Consultant, CMC, co-authored an article about technology transfer categories, essential elements, and documentation.
CDMO CMC
Scientific Articles September 20, 2023
Manufacturing Challenges of Therapeutic Antibody-Drug Conjugates
Our expert CMC team addresses the manufacturing challenges of ADCs in “Manufacturing Challenges of Therapeutic Antibody-Drug Conjugates.”
CMC Drug Development
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