Related Experiment Video
Updated: Jul 6, 2026
13:17
Manufacture of Concentrated, Lipid-based Oxygen Microbubble Emulsions by High Shear Homogenization and Serial Concentration
Published on: May 26, 2014
15.1K
Critical Needs and Opportunities for Advanced Manufacturing of Lyophilized Injectables.
Alina Alexeenko1, Maxwell Korang-Yeboah2, Serguei Tchessalov3
1Purdue University, West Lafayette, IN, 47907, USA. alexeenk@purdue.edu.
Pharmaceutical Research
|June 27, 2025
Summary
Lyophilized drugs, crucial for public health, face manufacturing challenges. This article presents solutions for producing these vital injectable medicines with extended shelf lives.
Area of Science:
- Pharmaceutical Technology
- Drug Manufacturing
- Public Health
Background:
- Lyophilized drugs and biologics are essential for public health, offering extended shelf life for stockpiling.
- Over 70% of antibiotics on the Essential Medicines list are supplied as lyophilized sterile powders.
- Many novel therapeutics, including immunotherapies, were initially launched in lyophilized form to expedite patient access.
Purpose of the Study:
- To address current manufacturing challenges associated with lyophilized injectables.
- To present short-term and long-term methodologies for improving lyophilized drug production.
- To disseminate findings from the National Institute of Pharmaceutical Technology and Education workshop.
Main Methods:
- The study is based on findings from a workshop held in January 2024.
- Methodologies discussed address both short-term and long-term manufacturing solutions.
- Focus on practical approaches to overcome existing production hurdles.
Main Results:
- Identification of key manufacturing challenges in lyophilized injectable production.
- Development of actionable strategies to mitigate these challenges.
- Framework for enhancing the efficiency and reliability of lyophilization processes.
Conclusions:
- Addressing manufacturing challenges is critical for ensuring the consistent supply of essential lyophilized medicines.
- Implementing proposed methodologies can improve drug availability and patient access.
- Continued research and collaboration are vital for advancing lyophilization technology.
Related Concept Videos
01:18Formulation and Manufacturing Process: Physical Attributes of Generic Tablets and Capsules
Bioequivalence in generic drugs, such as tablets and capsules, refers to their pharmaceutical equivalence to the brand-name counterparts. However, for therapeutic equivalence, manufacturers must also consider physical attributes like size, shape, and weight (FDA Guidance for Industry, December 2003). Discrepancies in these aspects could impact patient compliance and cause medication errors. For instance, swallowing difficulties, often experienced with larger tablets or capsules, can lead to...
01:24Site-Targeted Drug Delivery Systems: Polymeric Carriers
Polymeric carriers enhance targeted drug delivery by increasing efficacy while minimizing off-target effects. These carriers comprise a biodegradable polymeric backbone integrated with functional elements that enable targeting, improve physicochemical properties, and regulate drug release.Targeting MechanismsThe targeting ability of polymeric carriers is mediated by a homing device, which is a molecular recognition component designed to selectively bind to specific tissues or cells. Monoclonal...
01:28Parenteral Drug Delivery Systems: Injectables, Implants, and Infusion Devices
Parenteral drug delivery systems play a crucial role in modern therapeutics by enabling the direct administration of drugs into the systemic circulation, bypassing the gastrointestinal tract. These systems are particularly valuable for poorly absorbed oral medications that are unstable in the digestive environment or require rapid onset or sustained therapeutic levels. Delivery is achieved through intravenous, intramuscular, or subcutaneous routes, each selected based on the drug's properties...
01:27Upstream Processing
Upstream processing represents a critical phase in biomanufacturing, wherein biological systems such as microorganisms, mammalian cells, or insect cells are cultivated to produce therapeutic proteins, vaccines, enzymes, or other biologically derived products. This phase encompasses all steps from the selection and genetic manipulation of the production organism to the cultivation of cells in bioreactors under tightly controlled environmental conditions.Host Selection and Genetic OptimizationThe...
01:30Production of Pharmaceuticals
Industrial insulin production uses genetically engineered E. coli expressing a proinsulin gene controlled by a tryptophan promoter and containing a methionine linker for later cleavage. The cells also carry ampicillin resistance for selective growth. Seed cultures are stored at −80 °C and production begins by thawing a small amount to inoculate starter cultures, which are progressively scaled to a 50,000-L bioreactor. In the bioreactor, E. coli grow in nutrient-rich media under sterile, tightly...
01:23Vaccine Production
Vaccine production involves a sequence of upstream and downstream processes to generate a safe and effective immunological product. It begins with cultivating microorganisms, such as viruses or bacteria, to obtain antigenic material. For viral vaccines, mammalian host cells are grown in bioreactors and subsequently infected with the target virus. The virus replicates within the host cells, which are lysed to release viral particles. This lysate is then clarified through filtration or...