Watch on Demand! Regulatory Considerations, Use of Ancillary Materials in Biologics Nov 14th, 2023

by Natika Calhoun | October 17, 2023

51451_2023_EB_Symposium_1200x650_Speaker_Final

We invite you to the 4th Annual Biotech Start-up Symposium, a free, two-day event to help Biotech Start-ups navigate their path to commercialization. This Symposium features industry experts who present and discuss various aspects of emerging technologies and the latest trends in their fields.

On November 14th, Day 1, you won’t want to miss the presentation from Natika Calhoun on Regulatory Considerations: Use of Ancillary Materials in Biologics. 

Here is an overview of what is discussed:

What are the expectations for using qualified raw materials in developmental phases? There are many definitions, especially for novel modalities like Cell and Gene Therapies. Key definitions are evolving across agencies, and it’s necessary to understand regulations, guidelines, and international standards.

Watch on Demand!

Senior Regulatory Consultant

Natika Calhoun is a regulatory Subject Matter Expert for cellular and viral gene therapy products, biological APIs, and antibody-drug conjugates, based in California. In her current role, she works directly with manufacturing sites and customers as a regulatory liaison to support expansions, technical writings, filings, and submission success for clinical and commercial biological products.

Related Posts

Watch on Demand! Biolabs European expansion

BioLabs builds innovation communities around Biotech entrepreneurs providing them with infrastructure, support, and networking to successfully succeed. Hear...

Mirrored disco balls

Bridging the Sponsor – CMO Data Gulf

Single-source manufacture of biopharmaceuticals is becoming more and more rare. Increasingly, biomanufacturers or “sponsor” companies partner with contract…

Watch on Demand! The Current State of Emerging Biotech Venture Capital & How to Successfully Raise Funds

Insights on the changes in the biotech VC landscape and tips from an investor perspective for companies fundraising...

Strengthening the CDMO-Sponsor Partnership with Improved Data Sharing and Collaboration

Collaboration between biomanufacturers and CDMOs often experiences challenges with data sharing. This presentation highlights the management of heterogenous...

Good Laboratory Practice and the Impact on Start Up Companies

The definition of Good Laboratory Practice (GLP) is given by the Organization for Economic Co-operation and Development (OECD)…

Watch on Demand! Computer-aided design of living cells, November 14th 2023

We are developing a new way to program living cells by integrating synthetic biology, computational biology, and large...

Scroll to Top