<br />
FEATURED REPORT<br />
Scale-Up<br />
and Tech Transfer<br />
OCTOBER 2025<br />
01 Driving Innovation Through Phase-Appropriate<br />
Technology Transfers<br />
William Sanders<br />
04 From Bench to BLA: Synchronizing CMC Activities<br />
with Clinical Development for Robust and<br />
Compliant Biopharmaceutical Manufacturing<br />
NaveenGanesh Muralidharan, Austin Turner,<br />
Harald Michor, and Mark Davis<br />
15 Evolution of Mathematical Skills in<br />
Biomanufacturing and Scale-Up<br />
Jason Beckwith, Stephen Goldrick,<br />
William Nixon, and Stavros Kourtzidis<br />
25 A Strategic Approach to Technology<br />
Transfer and Scale-Up for<br />
Cell and Gene Therapies<br />
Drew Hope and Clare Blue<br />
29 Resources<br />
IMAGE BY ADOBE STOCK<br />
(HTTPS://STOCK.ADOBE.COM)<br />
SCALE OUT<br />
NOT<a title="October 2025 - Featured Report page 1" href="https://secure.viewer.zmags.com/publication/1f328869?page=1"> FEATURED REPORT Scale-Up and Tech Transfer </a>
<a title="October 2025 - Featured Report page 2" href="https://secure.viewer.zmags.com/publication/1f328869?page=2"> SCALE OUT NOT UP 6 x 2,000 L (12,000</a>
<a title="October 2025 - Featured Report page 3" href="https://secure.viewer.zmags.com/publication/1f328869?page=3"> Driving Innovation Through Phase-Appropriate Tech</a>
<a title="October 2025 - Featured Report page 4" href="https://secure.viewer.zmags.com/publication/1f328869?page=4"> )LJXUH ɄTechnology-transfer steps Initial evalua</a>
<a title="October 2025 - Featured Report page 5" href="https://secure.viewer.zmags.com/publication/1f328869?page=5"> Good to know. Good to go. Help ensure</a>
<a title="October 2025 - Featured Report page 6" href="https://secure.viewer.zmags.com/publication/1f328869?page=6"> From Bench to BLA Synchronizing CMC Activities wi</a>
<a title="October 2025 - Featured Report page 7" href="https://secure.viewer.zmags.com/publication/1f328869?page=7"> )LJXUH ɄLife-cycle framework for biopharmaceutica</a>
<a title="October 2025 - Featured Report page 8" href="https://secure.viewer.zmags.com/publication/1f328869?page=8"> manufacturing-relevant conditions to meet regulat</a>
<a title="October 2025 - Featured Report page 9" href="https://secure.viewer.zmags.com/publication/1f328869?page=9"> )LJXUH ɄStage 1A scale and technology transfer pr</a>
<a title="October 2025 - Featured Report page 10" href="https://secure.viewer.zmags.com/publication/1f328869?page=10"> )LJXUH ɄStage 1C process-characterization activit</a>
<a title="October 2025 - Featured Report page 11" href="https://secure.viewer.zmags.com/publication/1f328869?page=11"> TECH TRANSFER THAT KEEPS YOUR PROGRAMME MOVING </a>
<a title="October 2025 - Featured Report page 12" href="https://secure.viewer.zmags.com/publication/1f328869?page=12"> Knowledge gained during Stage 1 feeds into develo</a>
<a title="October 2025 - Featured Report page 13" href="https://secure.viewer.zmags.com/publication/1f328869?page=13"> )LJXUH ɄStage 2 process performance qualification</a>
<a title="October 2025 - Featured Report page 14" href="https://secure.viewer.zmags.com/publication/1f328869?page=14"> to recover viable cells. Once a culture has reach</a>
<a title="October 2025 - Featured Report page 15" href="https://secure.viewer.zmags.com/publication/1f328869?page=15"> testing. Regulatory filings must include reproces</a>
<a title="October 2025 - Featured Report page 16" href="https://secure.viewer.zmags.com/publication/1f328869?page=16"> PARALLEL PATHS TO SUCCESS Consistent delivery of </a>
<a title="October 2025 - Featured Report page 17" href="https://secure.viewer.zmags.com/publication/1f328869?page=17"> Evolution of Mathematical Skills in Biomanufactur</a>
<a title="October 2025 - Featured Report page 18" href="https://secure.viewer.zmags.com/publication/1f328869?page=18"> Emerging skill gaps spanning kinetic modeling, co</a>
<a title="October 2025 - Featured Report page 19" href="https://secure.viewer.zmags.com/publication/1f328869?page=19"> Therein, H represents the total energy in the sys</a>
<a title="October 2025 - Featured Report page 20" href="https://secure.viewer.zmags.com/publication/1f328869?page=20"> 7DEOH ɄKey biomanufacturing stages and mathematic</a>
<a title="October 2025 - Featured Report page 21" href="https://secure.viewer.zmags.com/publication/1f328869?page=21"> Accelerate your breakthroughs with our novel solu</a>
<a title="October 2025 - Featured Report page 22" href="https://secure.viewer.zmags.com/publication/1f328869?page=22"> )LJXUH Ʉ(A) Evolution of mathematical expertise d</a>
<a title="October 2025 - Featured Report page 23" href="https://secure.viewer.zmags.com/publication/1f328869?page=23"> control (9). Although quantum computing remains n</a>
<a title="October 2025 - Featured Report page 24" href="https://secure.viewer.zmags.com/publication/1f328869?page=24"> )LJXUH ɄGaps in mathematical expertise across tra</a>
<a title="October 2025 - Featured Report page 25" href="https://secure.viewer.zmags.com/publication/1f328869?page=25"> measurements and solves the problem again at the </a>
<a title="October 2025 - Featured Report page 26" href="https://secure.viewer.zmags.com/publication/1f328869?page=26"> REFERENCES 1 Villadsen J, Nielsen J, </a>
<a title="October 2025 - Featured Report page 27" href="https://secure.viewer.zmags.com/publication/1f328869?page=27"> A Strategic Approach to Technology Transfer and S</a>
<a title="October 2025 - Featured Report page 28" href="https://secure.viewer.zmags.com/publication/1f328869?page=28"> Developers must recognize that their clinical-tri</a>
<a title="October 2025 - Featured Report page 29" href="https://secure.viewer.zmags.com/publication/1f328869?page=29"> Simply increasing cleanroom size without process-</a>
<a title="October 2025 - Featured Report page 30" href="https://secure.viewer.zmags.com/publication/1f328869?page=30"> Process and Facility Considerations for Sc</a>
<a title="October 2025 - Featured Report page 31" href="https://secure.viewer.zmags.com/publication/1f328869?page=31"> Industry Resources Viral Vector Technolog</a>