cGMP Issues are increasing in Pharma Manufacturing. Let’s keep focusing oBest Practice.

cGMP Regulatory. Follow the rule.

cGMP Issues are increasing in Pharma. Let’s keep focused on Quality & People. Big Pharma and small companies alike are failing when it comes to cGMP violations. The increasing number and complexity of global regulations, outsourcing, price pressures, and compressed time to market all contribute to these failures. Consequently, the number of compliance issues is […]

Overcome The Challenges Of Small Batch Production While Maximizing Yield.

Overcome The Challenges Of Small Batch Production While Maximizing Yield.

Overcome The Challenges Of Small Batch Production While Maximizing Yield. A focus on niche drugs for targeted patient populations has led to an increase in small batch production across the pharmaceutical industry. These products include advanced therapy medicinal products (ATMPs) and high-value biologics that require very complex production processes or the use of expensive active […]

Precision Medicines: Adapting Manufacturing for Super Small Batch.

Precision Medicine - Small batch manufacturing

Precision Medicines: Adapting Manufacturing for Super Small Batch. Amid the excitement around the success of the development and manufacture of COVID-19 vaccines, it can be easy to forget the huge developments in other fields of research. One, which is creating a buzz in the pharmaceutical manufacturing sector, is the rise of personalized medicine. Many readers […]

Key Considerations in Capsule Filling

Capsule Filling Mix

Key Considerations in Capsule Filling Capsule filling is a complex process, and the product to be encapsulated must be well developed to ensure mass uniformity. Iñaki Bueno, formulation and manufacturing manager at Idifarma, and Rob Harris, chief technical officer at Juniper Pharma Services, share insights on the challenges of capsule filling. PharmTech: What type of […]

Sticky Formulations? Let’s look at how to overcome capsule-filling issues.

Overcoming Encapsulation Issues Caused By Sticky Formulations

Sticky Formulations? Let’s look at how to overcome capsule-filling issues. This guide provides a best-practices approach to troubleshooting capsule-filling problems when handling a sticky product formulation. A sticky formulation is one of the most common causes of issues during capsule filling. A capsule filler requires tight tolerances between the machine’s tooling components, including the dosing […]

Process Validation: Smarter Manufacturing data management.

Process Validation: Smarter Manufacturing data management.

Process Validation: Smarter Manufacturing data management. Data is prevalent through all functions of the Life Science industry. Its value impacts many disciplines throughout an organization, and while the use of data by discipline varies, it always involves:   Gathering and aggregating multiple types of data from multiple sources Making that data available across an organization […]

Fixed Dose Combinations in Capsules.

FDC single dosage capsule

Fixed Dose Combinations in Capsules Technological innovation has become increasingly critical for pharmaceutical companies as they struggle to achieve and maintain a competitive advantage. Industry trends, such as globalization, fast product-cycle times, increased competition, product commoditization, patient-centered approaches, and technology fusions, have added to this importance by creating new avenues of being competitive. Close examination […]

New drug-delivery capsule may replace injections

Capsule to deliver insuline

Can capsule deliver insulin? New technology say yes! Capsule that releases insulin in the stomach could replace injections for patients with type 1 diabetes. An MIT-led research team has developed a drug capsule that could be used to deliver oral doses of insulin, potentially replacing the injections that people with type 1 diabetes have to give […]

Virtual Factory Acceptance Testing: Dos And Don’ts.

Virtual Factory Acceptance Testing

Virtual Factory Acceptance Testing: Dos And Don’ts. Factory acceptance testing (FAT) is a critical process that relies on strong relationships between a life science manufacturer and its equipment vendor, as well as suitable technology and infrastructure. A smooth and successful FAT is often vital to the client’s production timeline. The FAT is performed at the […]