Formulation Development Featured Editorial

31. Enteric Coatings For Oral Solid Dosages: A Short Guide 11/19/2024

    Enteric coatings play a pivotal role for drugs/APIs that need to withstand the harsh conditions of the stomach in order to dissolve in the intestine. This article shares an overview, commonly used excipients, and more.

32. CMC Strategies With CDMOs: Ensuring CQAs For Oligos And Peptides 11/18/2024

    Developing a practical chemistry, manufacturing, and controls (CMC) strategy for oligonucleotides and peptides demands a shift in approach in terms of the way you collaborate with your CDMO.

33. Emerging Partnership Trends In Oligo-Based Medicines 11/6/2024

    The oligonucleotides sector is quickly evolving and seeing more industry partnerships than ever before. We caught up with DeciBio's Carl Schoellhammer and Phillip Leclair for their analysis.

34. Peptide Synthesis: New Market Research 11/3/2024

    Peptide synthesis is used to create new vaccines, medications, and enzymes. This article provides an overview of solid phase and liquid phase synthesis as well as new market research.

35. How Recce Is Delivering 5,000 Doses Per Week For Its Clinical Trials 10/25/2024

    Automation and the underlying chemistry of its R327 candidate have helped the antibiotic developer reach notably high production volumes.

36. EMA Issues Draft Guideline On The Development And Manufacture Of Oligonucleotides 9/26/2024

    The EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides. It includes requirements and considerations related to conjugation, active substance in solution, and more. The consultation period ends Jan. 31, 2025.

37. Araris Doubles Down With Dual-payload ADC 9/24/2024

    Antibody-drug conjugates usually deliver one payload type, which can overlook cancer’s complexity. A single ADC delivering two separate payloads could be the answer.

38. Accelerate CMC Development With Team Topologies 9/20/2024

    A method of defining role boundaries for knowledge workers in the IT industry maps nicely to CMC process development for biologics and pharmaceutical manufacturing.

39. Drug Product Formulation & Process Development: The Must-Have Skills At A Glance 8/26/2024

    Specialists in drug product formulation and process development at small biopharmas need to balance scientific knowledge and multidisciplinary know-how across the stages of product development.

40. Developing & Manufacturing Oligonucleotides: An Overview 8/22/2024

    An overview of considerations for the design and development, quality control and characterization, regulatory submissions, and future directions for oligonucleotides.