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

Executive Q&A: Samsung Biologics
Samsung Biologics continues to introduce new and innovative technology platforms with high-performing solutions that enhance therapeutic efficacy and proactively address evolving industry trends. read more
Whitepaper: Disinfectant Efficacy in cGMP-Compliant Pharmaceutical Manufacturing Settings
The FDA’s intensified onsite inspections of drug production post-pandemic have underscored the importance of robust cleaning- and disinfectant-validation programs. This whitepaper focuses on the importance of disinfectant validations based on real-world conditions to maintain cGMP compliance. It discusses the current lack of ... read more
Container Closure Requirements: Preparing for Updates to USP <382>, <661.1>, and <661.2>
This article will give a comprehensive overview of the evolving container closure requirements for parenteral products and insightful exploration of the alterations introduced by USP <661.1>, <661.2>, and <382>, equipping pharmaceutical manufacturers with the essential knowledge to navigate the evolving regulatory compliance standards effectively.... read more
App Note: To GMP or not to GMP? That is the (PLASMID) question
As drug manufacturers work to secure plasmids for discovery, clinical, and commercial applications, the question looms: how can you maintain a manageable budget while procuring a high- quality plasmid supply? Though opting to begin with a GMP-grade plasmid platform – as opposed to GMP-lite – may initially seem the more ... read more
Clean Labeling in Pharma: Enhancing Transparency and Trust
This article explores the significance of clean labeling in the pharma industry and how it is being utilized to meet consumer expectations. 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