Newsletter | November 17, 2023

11.17.23 -- FDA Seeks Comment On Quality Considerations For Topical Ophthalmic Drug Products Draft Guidance


Webinar: Reaching Biologics License Application Success Using A New, Fast-Track Approach To Process Characterization

Join us on November 30th to learn how in-depth knowledge of microbial processes and an unparalleled understanding of process characterization can be used to design targeted biologics license application (BLA) programs that can be executed effectively while managing risks for the objective of achieving a quick regulatory pass. Click here to learn more.


FDA Seeks Comment On Quality Considerations For Topical Ophthalmic Drug Products Draft Guidance

As a response to recent observations regarding the contamination of eye drops, the FDA published draft guidance titled Quality Considerations for Topical Ophthalmic Drug Products on October 13, 2023. In addition to addressing quality considerations, the guidance also provides recommendations about the CMC documentation. The deadline for submitting public comments is December 12, 2023.


8 Strategies To Attract And Retain Top Talent

In the fiercely competitive life sciences industry, attracting and retaining top talent can be challenging. Here are eight strategies successfully implemented at Verista to attract and retain top talent.

High Voltage Leak Detection For Parenteral Drug Container Closure Integrity

Pharmaceutical products are often packaged in fluid-filled containers. Learn about container closure integrity testing using high voltage leak detection (HVLD), how HVLD technology works, and more.

The Importance Of 503B Facilities In Drug Manufacturing Today

Here, we share one of the best ways to ensure sterility in aseptic compounding operations and how 503A and 503B pharmacies can achieve the adaptability they need to scale their operations.

Understand Key Process Development Challenges Of Recombinant Proteins

Once a company has demonstrated proof of concept, it is critical to consider process elements such as scalability, sourcing raw materials, and GMP adherence.

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.

Improving The Supply Of Single-Use Technologies

The use of single-use technologies has been growing steadily over the past decade, but there are still challenges that remain. Explore potential solutions for single-use supply constraints.

Understanding The Importance Of Tablet Punch Length And Cup Depth

Learn what punch length is, how to measure it correctly, and how wear affects length and tablet consistency. 

Modern Containment Solutions In OSD Processes

In the containment world for OSD processing, we see smaller batch sizes and more changeover. Here, we consider the pros and cons between hard-wall systems and flexible-wall containment systems.

Improving Sterility Assurance Within Lower-Grade Cleanrooms

Better aseptic powder handling through the use of high-tech split butterfly valves can improve patient protection, improve working conditions for staff, and cut costs with lower-grade cleanrooms.

Simultaneous Spray Drying For Combination Dry Powder Inhaler Formulations

Here, three combination case studies are demonstrated, in which bevacizumab is paired with erlotinib, cisplatin, or paclitaxel in a dry powder inhaler formulation.

Cold Chain Logistics And Packaging Considerations For High-Quality Probiotics

Choosing the right packaging partner for your probiotic may be the most crucial step to ensuring that your product is safe and potent when it reaches the consumer.

Pharmaceutical Cleaning And Disinfection Protocols For Annex 1

The new GMP regulations coming out of the European Union will have a big impact on pharmaceutical manufacturers. Learn about executing a CSS, cleaning and disinfection, and much more.

Pioneering The Future Of Pharmaceutical Supply Chains

Explore how integrating automation, AI, and effective communication will drive the efficiency and resiliency of supply chains, ensuring successful distribution of lifesaving medicinal products.

Efficient Track And Trace Solutions For An International Pharma Company

Understand how serialization and aggregation solutions allow Swiss-based Acino Pharma to serve its international customers quickly and reliably.

Regulatory And Commercial Insights To Maximize Digital Health

Gain insight into opportunities that leverage regulatory pathways and factors that will ultimately determine the commercial success or failure of digital products currently in development.

Predictive Modeling Of Concentration-Dependent Viscosity Behavior

Review a modeling approach that employs artificial neural networks using experimental factors combined with simulation-derived parameters plus viscosity data from 27 highly concentrated mAbs.


Webinar: Key Factors For A Successful API Supply — Meeting Worldwide Demand In Record-Breaking Time

Join us to learn about ESTEVE's project management flexibility and agility as a CMO, and how the global pandemic tested their limits, pushing them to achieve extraordinary results at light speed without compromising quality. They were able to help patients worldwide — find out on November 29th how their partnership can help you too! Click here to learn more.


Proper Data Management Across All Areas And Phases

Syringe And Cartridge De-Nesting System For Drug Manufacturing

Biological Indicator Designed For The Pharmaceutical Industry

Sterile Formulation And Fill/Finish For Early-Phase Clinical Trials

End-To-End Cold Chain Management Solutions


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