How do you ensure stability and shelf life for biologics / large molecules after synthesis?

Stability and shelf life are maintained through formulation optimization, stress testing, and accelerated stability studies following ICH guidelines, with buffer control, pH adjustment, stabilizers, cold-chain storage, and lyophilization to preserve biologics' efficacy.

Can large-molecule synthesis services handle both small-scale lab batches and commercial-scale production?

Modern large-molecule synthesis services support scalable production from small R&D batches to commercial-scale manufacturing, maintaining product quality, consistency, and regulatory compliance.

What cGMP or quality-compliance standards should a large-molecule CDMO/CRDMO follow?

Large-molecule CDMOs/CRDMOs must follow cGMP regulations, ISO 9001, ICH Q7/Q5 guidelines, and FDA & EMA GMP standards, with robust SOPs, batch records, and QC protocols to ensure consistent quality and regulatory compliance.

How scalable is large-molecule synthesis — from R&D batches to commercial-scale production?

Large-molecule synthesis is highly scalable using modular bioprocesses, optimized workflows, and automated cGMP facilities, allowing seamless scale-up from milligram-level R&D batches to kilogram or ton-scale commercial production without compromising quality or consistency.

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Large Molecule Synthesis

Pharmaffiliates believe in pure, innovative science.

“Science is more than a discipline — it’s a journey of curiosity, exploration, and bold thinking.”

Guided by this mindset, the team is deeply committed to crafting and developing complex, high-value compounds through advanced multistep synthesis. These intricate molecules serve as the backbone of modern scientific research and innovation.

Whether it's a milligram or a gram, each compound is built with precision, deep technical understanding, and a drive to meet the evolving needs of research and development teams across the globe.

Our expertise includes:

APIs and key intermediates
Chiral standards
Metabolites
Glucuronides
Stable isotopes

Based on our integrated and centralized operation and low overheads, we are able to offer prompt quotations, very competitive prices, high-quality products, and fast deliveries.

Related FAQs

Advanced analytical methods like HPLC, LC-MS, NMR spectroscopy, capillary electrophoresis, MALDI-TOF, and UV/Vis spectroscopy are used to ensure quality, purity, and structural integrity of synthesized large molecules. These techniques enable impurity profiling, structural confirmation, and molecular weight verification for regulatory compliance.

Stability and shelf life are maintained through formulation optimization, stress testing, and accelerated stability studies following ICH guidelines. Strategies like buffer control, pH adjustment, stabilizers, cold-chain storage, and lyophilization help preserve biologics' efficacy during storage and transportation.

Manufacturing large-molecule APIs and biologics must comply with global regulations, including US FDA 21 CFR Part 210/211, EMA biologics guidelines, ICH Q5A-Q5E, and WHO biopharmaceutical standards. These cover process validation, quality control, documentation, and ensuring consistent safety and efficacy.

Yes, modern large-molecule synthesis services support scalable production, from small R&D batches to full commercial-scale manufacturing. Scalable bioprocess technologies enable smooth transition while maintaining product quality, consistency, and regulatory compliance.

Large-molecule CDMOs/CRDMOs must follow cGMP regulations, ISO 9001, ICH Q7/Q5 guidelines, FDA & EMA GMP standards, with robust SOPs, batch records, and QC protocols to ensure consistent quality and regulatory compliance for biologics and large-molecule APIs.

Clients receive comprehensive data packages including structural characterization (NMR, MS), purity and impurity profiling, stability study results, formulation data, batch records, and QC reports to ensure traceability, quality assurance, and regulatory compliance.

Large-molecule synthesis is highly scalable using modular bioprocesses, optimized upstream/downstream workflows, and automated cGMP facilities. This allows seamless scale-up from milligram-level R&D batches to kilogram or ton-scale commercial production without compromising quality or consistency.