CDMO Selection and Outsourcing Support
Our technical experts help you develop and execute your clinical CMC strategy
Partner with our experienced CMC team to find, evaluate, and select a CDMO that fits your needs. We create tailored evaluation criteria focused on your product and strategic business priorities.
- Identify, evaluate, and select CDMOs based on the product profile and your company’s priorities
- Review and help negotiate master services agreements
- Provide technical oversight of the CDMO and advocate on behalf of the client to deliver clinical product on time
- Provide Quality oversight of all GMP operations
- Provide Regulatory/CMC strategy and advice captured and delivered in a dossier for FDA or EMA
We also support and oversee the following processes:
- Cell line, process, and formulation development
- Development and validation of analytical methods for in-process, release, and stability testing
- Design specifications for release of bulk drug substance and products
- GMP Drug Substance and Drug Product manufacturing
- Clinical packaging, labeling, and distribution
- Project Management
- Commercial manufacturing
Why choose Alira Health for CDMO selection and oversight?
As our client, you can rely on our dedicated, knowledgeable team to lead and support your outsourcing activities. You’ll benefit from our:
- Strong technical management at all stages from preclinical process development through manufacturing
- Commitment to client advocacy with vendors that drives holistic solutions tailored to your business needs and goals
- Full spectrum development support from product decision through clinical trials, process validation, and commercial manufacturing
- Packaging, labeling, and shipping support and management
CMC Outsourcing 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!
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.
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.”