Newsletter | December 2, 2021

12.02.21 -- Model-Based Control In Continuous Manufacturing Of Biotherapeutics: The Role Of Process Integration

 
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Understanding Multinational Regulatory Filings: New Chemical Entity

Finding the right CDMO partner for development and commercial launch of a new chemical entity presents sponsors with a challenging scenario that is magnified when a multinational launch is planned.

Small Molecule Orphan Drugs: Balancing Financial Incentives And Complex Challenges

Changing the lives of patients living with rare diseases requires collaboration, communication, and careful planning that incorporates regulatory, clinical, scientific, and commercial strategies. It also requires a commitment to advancing science to speed solutions.

Redefining Speed In Drug Development

An effective platform requires a CDMO team with deep expertise across not only cell lines and process development, but supply chains, engineering, commercial processing, and manufacturing technology.

Is Your API Ready For Scale-Up? What To Demand From Your CDMO

A CDMO that can optimize your API synthesis early during technology transfer will reduce the risk of delay or failure. That will also help your molecule run more efficiently in their plant.

Taking Biotherapeutic Candidates From Late Discovery To The Clinic

Many initially promising biotherapeutic candidates fail due to lack of efficacy or safety, but there are candidates that fail due to stability, aggregation, and other issues related to cell line or process issues. 

Water Activity Determination Of Oral Solid Dosage Products Using Frequency Modulation Spectroscopy

Controlling water content in oral solid dosage (OSD) products, and dry pharmaceutical products in general, is essential to maintaining efficacy and safety. Measuring the water activity at multiple time points during the product life cycle will correlate to changes in critical quality attributes such as degradation of the active ingredient, changes in the dissolution or disintegration rate, and changes in physical properties such as hardness or friability.

8 Misconceptions About Embedded CDMOs

Access to the expert capabilities of embedded CDMOs is offering great economies and competitive experience to the sector.

Assure Scalability, Overcome Regulatory Hurdles, And Speed Time-To-Clinic

The speed and quantity at which novel vaccines, therapeutics, and candidates are currently entering into clinical development is unparalleled. When partnering with a CDMO, first dive deeper into their manufacturing programs to get the specifics.

Spray-Dry Manufacturing Formulations For Local Lung Cancer Treatment

Recent advances in spray-drying technology show promising results and potentially facilitate more effective monoclonal antibodies (mAbs) through direct delivery to the lung.

The 5 Pitfalls Of API Development

No matter where you are in the API development life cycle, early planning makes a big difference. Every plan should keep these five key milestones — and potential pitfalls — in mind.

Finding The Ideal Balance: Where Risk And Cost Of Quality Meet

It is a constant challenge to keep improving product value for customers while reducing overall costs. Part of the solution resides in the functional activities of the risk involved and the cost of quality management. This article delves further into the ideas behind finding the ideal balance of where risk and cost of quality meet.

Developing A Closed Connected Single-Use mAb Purification Process
This article provides an overview of a successfully designed closed and physically connected monoclonal antibody (mAb) process at the pilot scale with single-use components.
Powder Shear Cell: Influence Of Humidity On Powder Characteristics Of Pharmaceutical Powders

Ambient conditions can strongly impact the behavior of many powders. In real life, bulk solids will show different flowability depending on the geographical location in which they are handled. While the impact of humidity in a saturated state is relatively simple to simulate by conditioning the sample in a climate chamber, it is more complex to depict the dynamic process which actually takes place in reality. In this article, the Anton Paar powder shear cell was used to determine different powder properties/processes such as flow behavior and caking at a wide range of relative humidity (7% to 95%).

Vessel Charging For IV Liquids Preparation

A customer had planned a new facility for the production of intravenous liquids. They were facing a challenge of charging multiple vessels with salt, glucose, and active carbon under controlled conditions achieving high accuracy. See what solution allowed them to create a highly automated high-capacity facility.

Process Intensification: Key Considerations And Expert Insights

In this e-book industry leaders discuss their experiences implementing process intensification strategies as they relate to unique organizational goals. 

Regulatory Services For Accelerated Development And Commercialization

Breakthrough therapy designations and other expedited regulatory reviews enable more innovation on shorter timelines to the clinic and commercialization, but they require careful navigation.

Advanced Analytical Tools For Drug Product Development

Gain insights on the applications of analytical techniques including Raman spectroscopy, nuclear magnetic resonance (NMR) spectroscopy, and mass spectrometry (MS). 

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