This article looks at the needs and challenges biotech organizations face during the manufacture of therapies, how they can reduce cost, and how establishing — or not establishing — partnerships with CDMOs can help get their therapies to patients faster.
- Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview
- Modularity And Mobility Hold The Keys To Surge Manufacturing
- Create The Correct Checklist To Land The Best CDMO
- 1 Year Out, Where Do We Stand On DSCSA Implementation?
- FDA Releases Guidance On Drug Products Containing Nanomaterials
- Frequent Deficiencies In GMP Inspections, Part 1
- The Upper Nasal Space: Drug Delivery’s Next Frontier
Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview
This article focuses on cleanroom gowning as it pertains to aseptic manufacturing of medicinal products and the updates to gowning requirements in the revised EU GMP Annex 1 document published in August 2022.
Modularity And Mobility Hold The Keys To Surge Manufacturing
When a global crisis or other demand calls for rapid mobilization, process equipment designed to be modular, multipurpose, and single-use all help with rapid scale-up.
Create The Correct Checklist To Land The Best CDMO
When considering outsourcing strategies, develop the right kind of checklist that considers human dynamics. This is not a script, nor is it static. Flexible enough to meet the needs of the project and the personnel, this spec will help you create frameworks, master service agreements, and quality agreements for best oversight of your supplier.
1 Year Out, Where Do We Stand On DSCSA Implementation?
This month kicks off the final year of a decade-long process to enhance overall security of the U.S. prescription drug supply chain under the Drug Supply Chain Security Act. This article looks at this year’s DSCSA implementation efforts, before examining where implementation currently stands and what gaps and challenges remain.
FDA Releases Guidance On Drug Products Containing Nanomaterials
In the FDA guidance entitled Drug Products, Including Biological Products, that Contain Nanomaterials, “nanomedicine” refers to a drug product that contains at least one component with a dimension in the size range of approximately 1 nanometer (nm) up to 100 nm. Focus of the guidance is on a risk-based regulatory strategy.
Frequent Deficiencies In GMP Inspections, Part 1
It is sometimes astonishing how often pharmas and biotechs "commit" similar or even the same GMP mistakes — in (almost) always the same places. Here are two of the most common pitfalls to avoid: inadequate handling of deviations and inadequate handling of changes.
The Upper Nasal Space: Drug Delivery’s Next Frontier
Oral formulations of drugs account for up to 75% of prescriptions. However, many diseases require therapies to provide a maximal benefit as quickly as possible, and oral delivery may result in slow absorption. Enter drug delivery via the upper nasal space, which has the potential to provide a more rapid onset of activity, avoid degradation in the GI tract, and more benefits.
India’s New Drugs, Medical Devices, And Cosmetics Draft Bill 2022
To accommodate changing requirements and encourage the adoption of new technology, India’s Ministry of Health and Family Welfare released a draft bill in July 2022 to replace the existing Drugs and Cosmetics Act 1940. What are the major areas of change and how much of an impact will there be?
PHARMA ONLINE WHITE PAPERS
Understanding FDA Guidance For Pediatric Oncology Studies
Learn how the Research to Accelerate Cures and Equity (RACE) for Children Act aims to improve and expand treatment options for pediatric cancer patients.
Microbial Control And Monitoring In Aseptic Processing Cleanrooms4/27/2021
Environmental Monitoring (EM), particularly in pharmaceutical manufacturing facilities where the risk of microbial contamination is controlled through aseptic processing, comprises both physical and microbiological test methods. This paper reviews how the data originating from these EM components provides critical information on how well a stable and suitable environment for the aseptic preparation of medicinal products is maintained.
Terminal Sterilization Of Prefilled Syringes2/22/2022
This paper describes which requirements must be considered regarding products and methods, and how risks can be avoided effectively during terminal sterilization of prefilled syringes.
A Five-Point Strategy For Building A CMC Dossier3/2/2022
By adopting strategies to build a robust CMC package to help streamline the path to FIH trials, innovators can establish a quality foundation to support the development phases toward commercialization.
Downstream Manufacturing Of Gene Therapy Vectors4/1/2021
The downstream manufacturing process takes the output from upstream operations and transforms it through multiple steps into a viable drug product ready for administration to patients. The major challenge in downstream processing is to maximize yield while meeting both product and impurity specifications. Viral vectors destined for clinical use must comply with regulatory standards for product safety and potency and this means contaminants must be removed and impurities controlled. This paper identifies challenges and opportunities to improve current operations and maximize yield.
Nanosuspension Dosage Forms: Product Development & Scale Up2/8/2022
For drug nanosuspensions, parameters like stabilizer concentration, drug loading, milling speed, milling time, bead diameter/density, and temperature are important formulation and process variables.
PHARMACEUTICAL ONLINE CONTENT COLLECTIONS
In pharmaceuticals, working effectively with contract development and manufacturing organizations (CDMOs) is an art as well as a science. Our latest e-book provides tips in selecting and working with a CDMO to accelerate the timeline for your drug development program through commercial manufacturing.More Content Collections