Speciality Chemicals Magazine MAR / APR 2025 | Page 18

PHARMACEUTICALS
• Updated cleanroom classifications
• Expanded guidance on aseptic processing and sterilisation methods
• New recommendations for single-use systems
• Enhanced personnel requirements and stricter utility specifications To ensure mAb therapies reach as many patients as possible , there is a growing trend among developers and manufacturers to prioritise a comprehensive understanding of evolving regulatory requirements and robust launch strategies .
This includes coordinating regulatory submissions in different regions , proactively managing potential variations in requirements and optimising the timing of market entry to maximise patient access . A strategic approach is crucial for the successful development and commercialisation of mAb therapies in an increasingly globalised market .
New modalities
The mAb landscape continues to evolve with the development of novel antibody therapeutic modalities . There is a growing trend towards BsAbs and multi-specific antibodies , which can simultaneously bind to multiple targets , offering more precise and potent effects and enhancing treatment outcomes for complex diseases . Since 2014 , the FDA has approved nine BsAb marketing applications . Over 100 more are currently in clinical development . 9
ADCs are another modality growing in popularity , combining the specificity of mAbs with the potency of cytotoxic drugs . They have shown significant potential in targeted cancer therapies , with eight ADCs gaining FDA approval between 2019 and 2022 . The number of clinical trials evaluating ADCs has also increased , reflecting the growing interest in this therapeutic approach . 10
The development of these modalities requires specialised expertise and advanced manufacturing capabilities . BsAbs , for example , involve complex engineering to ensure that the antibody can simultaneously bind to multiple targets without compromising its stability or efficacy .
The promise of ADCs hinges on their targeted delivery , but their production involves handling potent compounds , necessitating specialised facilities , stringent safety protocols and comprehensive personnel training . Manufacturers must prioritise safety through engineering controls and thorough toxicological assessments to develop tailored containment strategies .
Future of mAbs
The mAb landscape has undergone remarkable transformations over the past 30 years , driven by technological advances and a deeper understanding of disease mechanisms . As the market continues to expand , developers and manufacturers must navigate the evolving trends and challenges to effectively support mAb therapeutics .
Critically , this includes strategically selecting CMO partners with the expertise and capacity to support efficient and compliant mAb production . By adopting innovative technologies , investing in manufacturing capacity and preparing for increasingly stringent regulatory requirements , these partners can help developers meet the growing demand for mAbs and improve patient outcomes . ●
References : 1 : O . Leavy , Nature Reviews Immunology , 2010 , 10 ( 5 ), 297 . 2 : X . Lyu , Q . Zhao , J . Hui , T . Wang , M . Lin , K . Wang , J . Zhang , J . Shentu , P . A . Dalby , H . Zhang & B . Liu , Antibody Therapeutics , 2022 , 5 ( 4 ), 233 – 257 . 3 : Precedence Research , Monoclonal Antibodies Market , 2022 . https :// www . precedenceresearch . com / monoclonal-antibodies-market 4 : Absolute Antibody , Antibody Engineering & Humanisation , 2022 . https :// absoluteantibody . com / antibody-resources / antibody-engineering / humanisation /
5 : G . R . Bolton & K . K . Mehta , Biotechnology Progress , 2016 , 32 ( 5 ), 1193 – 1202 . 6 : M . Pappenreiter , H . Schwarz , B . Sissolak , A . Jungbauer & V . Chotteau , Journal of Chemical Technology & Biotechnology , 2023 , 98 ( 7 ), 1658 – 1672 . 7 : M . Pohlscheidt et al ., American Pharmaceutical Review , 27 January 2023 . https :// www . americanpharmaceuticalreview . com / Featured- Articles / 144184-At-Scale-Analysis-and- Optimization-of-a-Cell-Culture-Harvest-Process- Mitigating-Risk-and-Optimizing-Performance /
8 : FDA , 14 February 2024 . https :// www . fda . gov / drugs / news-events-human-drugs / bispecific-antibodies-area-research-and-clinicalapplications 9 : European Union ( EU ), 22 August 2022 . https :// health . ec . europa . eu / system / files / 2022-08 / 20220825 _ gmp-an1 _ en _ 0 . pdf 10 : S . D . Barnscher , Clinical Leader , 16 March 2022 . https :// www . clinicalleader . com / doc / the-clinicallandscape-of-adcs-in-diverse-technologiesnarrow-target-0001
Jenny Gattari
BUSINESS DEVELOPMENT LEAD ,
PFIZER CENTREONE
k + 1 847 772 8583 , J jennifer . gattari @ pfizer . com j https :// www . pfizercentreone . com
18 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981