Formulation Development

Pharmaceutical formulation development is the critical step which links the discovery of a novel drug to commercialization. During this step, formulation scientists will determine the best drug delivery vehicle and dosage form needed to deliver a therapeutic effect based on bioavailability or other factors. Below you can explore articles, industry trends, and curated products which can help increase formulation development efficiency.

The Asymmetry Advantage: Why Early Chiral Strategy Determines API Success
Chromatography has an important role, but relying on it too long may cost of goods, extend timelines, and complicate regulatory submissions. read more
Lyophilization and Next-Generation Therapeutics: The Challenges of Scaling Up
Lypophilization helps stabilize fragile new modalities, including messenger RNA and the advanced formulation vehicles that deliver them. read more
Rethinking ADC Payloads From Cytotoxics to Targeted Small Molecules
Many patients abandon ADC therapies due to the associated toxicities. The next major leap requires designing targeted small molecules for conjugation. read more
The Use of Mycoplasma Reference Standards in the Light of the Revised Ph. Eur. 2.6.7
On 1 April this year, the Ph. Eur. Chapter 2.6.7, in its thoroughly revised form, came into force. It applies to medicinal products derived from or manufactured using living cells or biological systems and that have a realistic risk of contamination by Mollicutes (including the genus Mycoplasma). read more
Comparative Evaluation of the Efficacy of Glycopyrronium Versus Tiotropium as an Adjunct to Formoterol Therapy in COPD: A Questionnaire-Based Investigation at a Tertiary Care Facility
GFF treatment led to a significant improvement in FEV1% and FEV1/FVC ratios and resulted in faster, more consistent improvements than TFF. read more
Design, Synthesis, Characterization, and ADME Study of Novel 1,2,4-Triazole Derivatives as Anti-Tubercular Agents
In vitro anti-tubercular activity of the two novel 1,2,4-triazole derivatives demonstrated dose-dependent inhibition of Mycobacterium tuberculosis. read more

eBook: Raman Imaging in Pharmaceutical Research
In order to ensure the efficacy and safety of pharmaceutical formulations, their chemical composition needs to be monitored during the entire development and production process. read more
Analyses of Antibody Drugs Using Inert Ultra High Performance Liquid Chromatography
This article introduces analyses of monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs) for quality control using an inert UHPLC system that is extremely resistant to mobile phases containing high salt concentrations. By suppressing the interaction between antibody drugs and stationary phase, the system delivered ... read more
Whitepaper: QC Executive Q&A - Research and Development of Protein-Based Therapeutics
As a global provider, MilliporeSigma offers a wide range of products and services to biopharma. On the analytical side, we have a growing selection of chromatography and sample preparation products for development and QC laboratories. read more
Whitepaper: Key Considerations for Extracting Proteins from Recombinant Host Cells
In the biopharmaceutical industry, quality is pivotal. For a final product to meet quality standards, quality must be built into the production process. Biopharmaceuticals, however, are made from biologically sourced materials, which are inherently variable. read more
eBook: Glass Related Recalls in Pharma
Typically, drug recalls fall into two categories: recalls issued for the cracking or breaking of glass vials and recalls issued for the presence of particulates being detected in the drug solution. read more

Recent Advances in Crystalline Polymorphism Research in Drug Development
This webinar explores recent advancements in crystal screening and characterization for pharmaceutical development. read more
Speed Meets Precision: Fast Raw Material ID & Advanced Peptide Characterization
As the demand for therapeutic synthetic peptides—such as GLP-1 receptor agonists—continues to surge, biopharmaceutical manufacturers are under increasing pressure to scale production efficiently while maintaining rigorous quality standards. This ... read more
Building Agile Aseptic Operations with Skilled Teams and Smart Tech
The biopharma world is evolving rapidly, driven by rising demand for biologics and advanced therapeutics. To stay ahead, companies are adopting smart technologies and empowering teams to embrace new production methods while meeting strict regulatory ... read more