PEPTIDES & PROTEINS
develop pre-formulation properties and characterisation data . From there , biopharmaceutical researchers can develop a formulation strategy , selecting the appropriate technology to ensure stability and developing the drugs with the right quantities .
The next set of steps is probably familiar . After proof of concept and dosage form approval , evaluation in vitro is essential before the therapies can be considered for clinical trials .
Accelerated development of oral delivery peptides requires optimising the formulation , understanding the scalability and developing processes to ensure quality throughout the complex drug development journey . It is critical to define the requirements for characterising peptides and proteins before incorporating them into a drug product , followed by establishing validated analytical techniques to confirm the potency , purity and uniformity of these substances in the finished oral tablet or capsule , as well as their stability .
The recent success of GLP-1 therapies from Novo Nordisk and Eli Lilly for diabetes and weight loss sparked tremendous interest in oral peptide development , with at least a dozen next-generation peptides in various clinical phases to show efficacy in these indications and others .
With advances in science and technology , combined with the comprehensive support of a skilled and trusted CDMO partner , biopharmaceutical companies can
Figure 3 – Site-specific delivery of pellet , bead or mini-tablet to small intestine or colon Source : Acta Pharmaceutica Sinica B 2021 ; 11 ( 8 ): 2416e2448
deliver innovative peptide , protein and large-molecule therapies in formats that enhance accessibility and convenience . CDMOs with proven expertise , robust infrastructure and a deep understanding of peptide development are uniquely positioned to help overcome challenges , accelerate timelines and bring lifechanging medications to patients more efficiently . ●
Reference : 1 : Roots Analysis , 15 June 2022 . The Oral Proteins and Peptides Market is Anticipated to Grow at a CAGR of 20 % During 2022 – 2032 https :// www . globenewswire . com / news-release / 2022 / 06 / 15 / 2463158 / 0 / en / The-oral-proteins-and-peptides-market-is-anticipated-to-grow-at-a- CAGR-of-20-during-2022-2032-claims-Roots-Analysis . html
J j
Anil Kane
GLOBAL HEAD OF TECHNICAL & SCIENTIFIC AFFAIRS
THERMO FISHER SCIENTIFIC anil . kane @ thermofisher . com www . thermofisher . com
34 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981