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February 25

This week is an important one for us at The Pharmaceutical Sciences, Manufacturing & Marketplace Report eNewsletter and Pharmaceutical Technology/BioPharm International Marketplace. The first issue of the eNewsletter will be published this week.

For this issue, thank you to those who shared  your knowledge and expertise on hot-melt extrusion and highly potent APIs as well as to the Bio-Process Systems Alliance, Thermo Fisher, and AAIPharma Services for providing insight, respectively, into single-use technologies, handheld analytical tools, and the growing sterile-manufacturing market.

If you have not done so, please signup to receive the The Pharmaceutical Sciences, Manufacturing & Marketplace Report.

We also want your feedback. Were these articles of value to you? What did you like best? What was missing? Are there related topics that we should cover? Please let us know.

At this time, I would also like to invite contributions to this blog to gain your perspective of leading scientific trends and issues affecting drug development and manufacturing. If you have knowledge of a new technology for biologics manufacturing, a novel analytical technique, a solid- dosage manufacturing solution, a new piece of product equipment or process for chemical API manufacturing, or advances in parenteral-drug manufacturing, we are interested in gaining your perspectives.

Cynthia A. Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report

InformEX USA Arrives

February 19

It is hard to believe, but InformEX USA week is here. Many pharmaceutical company representatives (as well as decision-makers from other sectors that use fine and specialty chemicals) will be in Anaheim, Calif., this week to see the latest offerings from suppliers of raw materials, intermediates, and custom and batch manufacturing services.

Trade shows, such as InformEX, provide a useful venue for companies to inform customers of their differentiated capabilities and technologies.  Companies can use trade shows to introduce new products, develop sales leads with both existing clients and new prospects, maintain existing customer relationships, collect competitive information, take orders, and promote awareness of their companies. They can also keep abreast of emerging technologies, regulatory issues and general industry trends.  Importantly, they provide the opportunity for effectively networking with a large number of people in one location, which is particularly invaluable for smaller firms.

Because we recognize the value of these events, each issue of the Pharmaceutical Sciences, Manufacturing & Marketplace Report will be associated with one or more key shows, conferences, or association meetings and the leading communities in each issue will be related to those events.

In addition to InformEX we will be offering insight aligned with other key industry events, such as PITTCON, DCAT Week, INTERPHEX, the BIO International Convention, the PDA Annual Meeting, ExcipientFest Americas, ChemSpec Europe, the Controlled Release Society Annual Meeting, & Exposition, the Bio-Process Systems Alliance (BPSA) Single-Use Summit, PharmaChem Outsourcing, CPhI Worldwide, the AAPS Annual Meeting & Exposition, the ISPE Annual Meeting, the CHI Bioprocessing Summit, and more.

We welcome your suggestions, too. If you have gained valuable information and insight by attending an event or if would like to inform us of your company’s news developments from these events, please let us know.

Remember, you need to sign up to receive the Pharmaceutical Sciences, Manufacturing & Marketplace Report eNewsletter.

Cynthia A. Challener, PhD

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report

Suggestions Welcome

February 11

As we prepare for the first issue of The Pharmaceutical Sciences, Manufacturing & Marketplace Report, a new specialized biweekly newsletter of Pharmaceutical Technology and BioPharm International, scheduled for Feb. 27, we are interested in gaining your input on topics of interest to you. The eNewsletter is an exclusive feature of the new Pharmaceutical Technology/BioPharm International Marketplace, an online community focused on products and services for drug development and manufacturing, which will be launching in beta shortly and formally in April.

The Pharmaceutical Sciences, Manufacturing & Marketplace Report will provide insight in five main communities: solid dosage, semisolid, and specialty dosage forms; parenterals; chemical API manufacturing; biologic API manufacturing; and pharmaceutical analysis. We want to be sure to cover the latest research and development activities with real commercial potential, product and service innovations, and leading thoughts and positions on the most important issues in the fast-changing pharmaceutical/biopharmaceutical manufacturing marketplace.

What better way to do so than to have our readers tell us what they want to know?

We welcome your suggestions. Is there a certain solid dosage application for which you need to find an appropriate excipient? Do you need to learn more about continuous manufacturing or process analytical technology? Are there aspects of quality by design for parenterals that you would like clarified?

We will be speaking with scientists and manufacturing experts from the pharmaceutical/biopharmaceutical companies, CMOs and CDMOs, equipment and analytical instrument manufacturers, excipient producers, catalyst and cell-media suppliers, leading academicians, and top industry trade associations. Some of the topics you can look forward to in future issues of the The Pharmaceutical Sciences, Manufacturing & Marketplace Report include:

·         Solid-dosage: spray drying; continuous tableting equipment; taste-masking;

·         Parenterals : prefilled syringes; lyophilization; equipment issues

·         Chemical API manufacturing: new alliances for biocatalyst development; chiral catalysts; fluorochemistry; high-throughput equipment

·         Biologic API manufacturing: production of fragile cells; raw-material qualification; cell- culture media; peptoids

·         Pharmaceutical analysis: advances in ultra high-performance liquid chromatography (UHPLC); microbiological testing; fluorescence spectroscopy; protein analysis

We believe these are important issues in pharmaceutical and biopharmaceutical development and manufacturing. But you are the experts. Please let us know if there are particular topics, or even certain aspects of particular topics, that you would like to see examined.

We want The Pharmaceutical Sciences, Manufacturing & Marketplace Report to contain information that is helpful to you. So please be sure to let us know on this blog what you need to know, and we will do our best to get answers to those questions.

If you haven’t yet, please sign up to receive The Pharmaceutical Sciences, Manufacturing & Marketplace Report here.

Cynthia A. Challener, PhD

Editor, The Pharmaceutical Sciences, Manufacturing & Marketplace Report

Newsletter Debut

February 4

The first issue of the Pharmaceutical Sciences, Manufacturing & Marketplace Report, a new specialized biweekly newsletter of Pharmaceutical Technology and BioPharm International, is set to launch on Feb. 27.  The eNewsletter is an exclusive feature of the new Pharmaceutical Technology/BioPharm International Marketplace, an online community focused on products and services for drug development and manufacturing, which will be launching in beta shortly and formally in April.

The first edition of the Pharmaceutical Sciences, Manufacturing & Marketplace Report will provide insight for our five main communities:

Solid dosage, semisolid, and specialty dosage forms. We examine the use of hot-melt extrusion (HME) for the solid dispersion of poorly soluble drugs by addressing excipient selection and functionality, recent advances in HME technology, challenges in the technology, and best practices for for formulators given the current state-of-the-art.

Parenterals. In an editorial podcast, AAIPharma discusses its recent expansion of its parenteral manufacturing facility, including the rationale for the investment, the specific capabilities it added and why, and what challenges the company faced during the expansion.

Chemical API manufacturing. Our focus is on highly potent APIs (HPAPIs). Custom manufacturers share their experiences regarding the manufacture of highly potent chemical compounds, including the challenges of HPAPI manufacturing, the latest technologies, recent investments in production capabilities, and anticipated future developments.

Biologic API manufacturing:  We explore the adaption of single-use technologies. Kevin Ott, president of the Bio-Process Systems Alliance (BPSA), discusses recent developments for single-use technologies, the major challenges that remain, the key trends and issues that his organization is addressing, and what BPSA has planned for 2013.

Pharmaceutical analysis. We examine portable analytical technologies through insight provided by ThermoFisher Scientific on hand-held instruments for the analysis of pharmaceutical raw materials, the solution it has developed, and other potential uses throughout the pharmaceutical supply chain and manufacturing processes.

Sign up to receive the Pharmaceutical Sciences, Manufacturing & Marketplace Report here.

Cynthia A. Challener, Ph.D.

Editor

The Pharmaceutical Sciences, Manufacturing & Marketplace Report