On the Minds of Formulation, Analytical, Process Development and Manufacturing Scientists

This week marks the third issue of The Pharmaceutical Sciences, Manufacturing & Marketplace Report eNewsletter, and I am very pleased with the positive responses I have received from all of the contributors to these first issues. Although I have been involved in the chemical and allied industries in some capacity for nearly 30 years, as I work on this newsletter, I am reminded and impressed at the level of innovation and rapidity of technological advance that is achieved on a regular basis.

That is why your input to the newsletter is so important. Our goal is to share with our readers the advances in your company’s product and service offerings and how their practical application is resolving the scientific challenges in drug development and manufacturing. That goal can’t be achieved without insight from you, whether you are a formulation and drug-delivery scientist, analytical chemist, process development and manufacturing scientist, engineer, QA/QC professional, or production expert.

Here are the topics I am working on for the April issues of The Pharmaceutical Sciences, Manufacturing & Marketplace Report. Please let me know if you have a particular question you would like to see addressed.

·         Parenterals: Scale-up considerations for freeze-drying  and advances in visual inspection systems

·         Biological API Manufacturing: Developments in cell culture media and peptoids

·         Pharmaceutical Analysis: Advances in particle size analysis and protein analysis

·         Chemical API Manufacturing: Fluorochemistry and the use of microreactor technology

·         Solid Dosage, Semisolid, and Specialty Dosage Forms: Taste Masking and advances in mixing and blending equipment

I am also considering topics for future issues The Pharmaceutical Sciences, Manufacturing & Marketplace Report. Please let me know if there is a topic you would like to have covered. I also welcome contributions – both to the eNewsletter and to this blog. I am eager to more voices involved in the conversation, so please let me know if you have something you would like to say.

And don’t forget. If you haven’t already, you can sign up for the Pharmaceutical Sciences, Manufacturing & Marketplace Report here.

Cynthia A. Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report

Evolving Pharmaceutical Industry Fundamentals Create Technical Challenges

The pharmaceutical industry is evolving from one focused on the development of blockbuster drugs to one dominated by niche, small-volume therapies, a trend that is affecting all drug product forms, from solid dosage to parenterals. At the same time, the number of large-molecule biologics is increasing at the expense of small-molecule APIs.

Attendant to these changes is the ongoing need to improve drug product forms to ensure patient compliance and convenience, which is seen in increased demand for prefilled syringes, a topic that we cover in the March 13 issue of The Pharmaceutical Sciences, Manufacturing & Marketplace Report.  Prefilled syringes offer several advantages to pharmaceutical companies and CMOs/CDMOs, as well as healthcare professionals and patients. Lower cost, increased convenience, reduced risk of contamination, greater safety, all are factors driving the growing interest in this method of drug delivery.

Of course, there are also more manufacturing steps involved. The viscosity of the formulated drug can cause issues, and glass breakage is a real concern if the syringe design is not matched properly with the properties of the drug product. Interactions between the API and the wall of the syringe can come into play as well.

• ·         What is your experience with prefilled syringes? Do they provide added convenience for the user?
• ·         Can they increase productivity at healthcare facilities?
• ·         How important is the issue of viscosity, and can it be overcome with traditional syringe designs, or are new technologies needed?
• ·         What other advances might be anticipated in the future in the area of prefilled syringes?

Speaking of the future, we are looking forward to the publication of the third issue of The Pharmaceutical Sciences, Manufacturing & Marketplace Report. With INTERPHEX coming up next month (April 23-25), we have gathered input from leading producers of equipment for solid-dosage manufacturing on continuous tableting and mixing and blending.

Other topics to be covered in the third issue of The Pharmaceutical Sciences, Manufacturing & Marketplace Report include the following:

• ·         Advances in chemical catalyst technology for chiral synthesis
• ·         Issues surrounding the filtration of parenterals
• ·         The introduction by SAFC of new Pharma Grade raw materials
• ·         A discussion of the advantages of rapid microbiological testing

Are any of these topics hot button issues for you? Please weigh in with your thoughts. Why are they important? What technical advances are most noteworthy? What problems or limitations remain?

Make sure, if you haven’t already, to sign up to receive The Pharmaceutical Sciences, Manufacturing & Marketplace Report so that you can read what experts in the field have to say about these topics. Then come back and let us know whether you agree or disagree with the points they make, or if a key concept was overlooked. 

Cynthia A. Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report

Rising Interest in Ultra-High Pressure Liquid Chromatography

I am happy to report that the second issue of The Pharmaceutical Sciences, Manufacturing & Marketplace Report eNewsletter will be coming out this week.

With the PITTCON Conference & Expo coming up March 17-21 in Philadelphia, we have made pharmaceutical analysis are featured community.  Specifically, we asked ultra-high pressure liquid chromatography (UHPLC) instrument manufacturers to comment on why there is such a growing interest in this analytical technology, what its current limitations are, and what the future might hold.

They see the use of UHPLC as improving profitability through increased throughput, both in the R&D and development phases and for production batch analyses. UHPLC also enables online monitoring and multi-residue analyses. Do you agree? How are you benefiting from the use of UHPLC?

With respect to limitations, most see workflow as the major issue, with sample preparation a particular bottleneck for many companies. Automation is suggested as a way of addressing this issue. Do you think it will have a real impact? They also point to the need for enhancement in selective detection technologies. Do you have other issues with UHPLC?

Finally, do you see UHPLC becoming a universal separation method?

In this second issue of The Pharmaceutical Sciences, Manufacturing & Marketplace Report eNewsletter, you will also find stories about pre-filled syringes, the agreement between DSM Pharmaceutical Products and The Almac Group to share their enzyme  biocatalysis expertise and assets for more effective route development and scale up, a collaboration by The Dow Chemical Company and Bend Research for the development and commercialization of new materials for spray-dried dispersions of poorly soluble drugs, and a specially designed reactor from ATMI for larger scale production of fragile cells.

Are any of these topics of importance to you? Are you, for example, interested in screening biocatalysts earlier in the development phase, but not sure how to proceed? Are you looking for improved processes for the preparation of spray-dried dispersions? Perhaps you have a stem-cell base product but its development has been stalled due to lack of a practical means for scale-up. What are your concerns?

Help start a conversation. New thoughts and ideas are needed for innovation to take place. Raw materials and excipient producers, equipment manufacturers, and CMOs and CDMOs need your input in order to develop the products and services that will maximize your productivity, efficiency, and quality. Let them know what is important to you.

And look for the second issue of The Pharmaceutical Sciences, Manufacturing & Marketplace Report this week. If you haven’t signed up to receive it yet, take the opportunity right now. Just click here.

Cynthia A. Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report

Evaluating the Technology for Hot-Melt Extrusion and Highly Potent APIs

Have you seen the first issue of The Pharmaceutical Sciences, Manufacturing & Marketplace Report yet? As editor of the eNewsletter, I look forward to your feedback.

Our feature story focused on the critical issue of solubilization strategies for poorly soluble drugs, which is a growing challenge as a greater number of new drug candidates fall into this category. We examined the use of solid dispersions through hot-melt extrusion (HME) as one strategy. Let us know how you are leveraging HME in your developmental or commercial work or share your opinion on the advantages or limitations of the technology. Some points for your input:

• ·         Do you see HME as having real potential to increase the availability of poorly soluble drugs or are its limitations (the need for thermally stable APIs, for example) too difficult to overcome?
• ·         How important is the fact that no solvents are used in this type of solid dispersion process?
• ·         Do you agree that the development of excipients that are specifically designed for use with HME will have a big impact?
• ·         What do you think can be done to improve the mixing efficiency when using HME?

We also turned to experts in the manufacture of highly potent APIs (HPAPI) to learn about recent advances in handling these types of compounds. The availability of HPAPI capacity is of growing importance because of demand for new drug substances, particularly oncology therapies, which are highly potent and that require specialized containment for their manufacture.  Some points for your input:

• ·         What are you looking for when you need to find a custom manufacturer for your highly potent compounds?
• ·         What banding system does your company use for categorizing HPAPIs?
• ·         Is it important to find one supplier that can provide material from development through commercialization?
• ·         In your experience, what are the biggest challenges when manufacturing HPAPIs?

Having been involved in the chemical and allied industries in roles that included basic R&D, technical support, business development, regulatory management, and now as a science/business editor, it has become abundantly clear that the sharing of knowledge and expertise across all aspects of a business is critical for the development of successful advances in both practical technological and business solutions.

Please share your experiences that are important to further progress in the pharmaceutical industry.

And don’t forget. If you haven’t already, you can sign up for the Pharmaceutical Sciences, Manufacturing & Marketplace Report here.

Cynthia A. Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report