Biologics CMC leadership for IND, technology transfer, and US-China CMC review.

Led by Frank Song, a biologics CMC and upstream process leader with 25+ years across cell line development, media formulation, tech transfer, and US-China programs.

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Advisory services

CMC strategy and execution for biologics development

Support for biologics teams where CMC assumptions affect IND submission, manufacturing transfer, comparability, or cross-border asset evaluation.

CMC Lead Support for IND Submission

Frank provides CMC lead support for biologics IND preparation, with particular depth in upstream development and cell culture media formulation. He helps teams define cell line strategy, media and feed strategy, upstream process plans, CDMO technical interfaces, and IND-enabling CMC documentation grounded in practical development and manufacturing experience.

Scope includes

CMC development plan
Cell line and expression-system strategy
Cell culture media formulation development
Upstream process development plan
CDMO technical interface
CMC documentation for IND preparation

Full detail on IND CMC support →

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Track record

Operating history behind the advisory work

20+

Biologics programs involving cell line development across mAbs, bispecifics, and ADCs

$10M+

Revenue at Eminence Biotechnology under Frank's leadership

GMP cell culture media manufacturing facilities built and run

Cell culture media and protein expression products launched

Patents

$45M+

Raised across venture, strategic, and government funding channels

Additional program experience includes ADC programs advanced into clinical development across the US, China, and Australia.

Engagement model

How engagements work

Step 1

Introductory call

A focused discussion to understand the program, current CMC risks, timeline, and decision points.

Step 2

Scoped engagement

Engagements may be structured as a monthly advisory retainer, a defined project, or short-form technical review, depending on the program need.

Step 3

Embedded execution

Song Consultancy works with the internal team, CDMO, originator, or investor group to drive the agreed deliverables.

About Frank Song

Built Across Boundaries

Frank Song brings more than 25 years of biologics CMC and upstream development experience across the US and China. His background spans cell line development, protein production, upstream process development, technology transfer, and cell culture media formulation development.

Earlier in his career, Frank held hands-on technical roles at Regeneron, Laureate Pharma, Ambrx, and EMD Millipore, supporting biologics programs from bench development toward clinical execution.

In 2016, Frank founded Eminence Biotechnology in Suzhou, China and led the company as CEO through 2024. Under his leadership, Eminence grew into a profitable cell culture media and protein expression business with more than $10 million in revenue, 23 commercial products, and two GMP cell culture media manufacturing facilities.

This operating range is central to Song Consultancy's value. Frank has worked as a scientist, process leader, founder, and CEO. He understands not only the technical decisions behind biologics development, but also the business constraints, manufacturing realities, and cross-border communication challenges that determine whether a program can move forward efficiently.

MD, Jiaotong University (Shanghai) · M.S. Pharmacology, St. John's University (NY) · fluent in English and Mandarin · 26 patents

Contact

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