As fine-chemical producers, custom manufacturers, and pharmaceutical companies gathered this week for Informex in Anaheim, California, one observation stands out: for all the inroads that biologic-based drugs have made, the pharmaceutical industry remains a small-molecule marketplace. Read more »

Pharmaceutical Technology and Patheon are partnering to provide you—our readers—with CMC advice from some of the leading formulation scientists and pharmaceutical manufacturing experts in the world. To get started, we need to know what plagues your CMC strategies and daily work. Email your questions directly to Editorial Director Angie Drakulich at adrakulich@advanstar.com. (*Note: We will keep your name and company affiliation anonymous.)

Answers will be provided by the Patheon Certified Consultants team beginning in the January 2013 print and online editions of PharmTech. These experts have collectively brought more than 200 pharmaceutical products to market, including some of the world’s largest blockbusters.

Sample questions:

• I have a BCS Class II compound for which amorphous solubility is easily sustained, but I can’t get the compound to rapidly dissolve. What are some solutions, particularly with respect to excipient selection?
• I have a compound that is non-ionizable and does not form a stable salt. Are co-crystals my best option and what are the key criteria in identifying a suitable co-crystal?
• I am having trouble maintaining product stability when scaling up a lyophilization process. What are the likely factors causing the problem?

In 2008, adverse affects and deaths linked to Baxter’s blood thinner drug heparin revealed contamination in the heparin supply chain originating from an API manufacturer in China. FDA identified oversulfated chondroitin sulfate (OSCS) in the contaminated heparin. In response to the 2008 heparin situation, the United States Pharmacopeia Convention (USP) has revised the quality standards for heparin. Anita Szajek, PhD, and Tina Morris of USP highlight USP’s revisions to the heparin sodium monograph in the September 2012 issue of PharmTech.

It’s no secret that excipients are not manufactured specifically for pharmaceutical use. In fact, pharma appears pretty low on many excipient makers’ lists of clients. But their importance in drug formulation and in ensuring final product quality has been gaining recognition over the past few years, unfortunately due to some specific events of contamination and adulteration. Because of growing concern in how excipients function and perform, the US Pharmacopeia has developed a new general information chapter on this topic, chapter <1059>. Read more »

Last week Human Genome Sciences (HGS) rejected GlaxoSmithKline’s (GSK) unsolicited $2.59 billion bid for HGS or $13 per share.  Although rejecting GSK’s initial bid, HGS kept the door open for other suitors, including again GSK. Read more »

This week an interesting report was released about the use of gelatine in medicines. Most of us are comfortable with the use of animal products as ingredients, but for vegetarians or other people that follow restrictive diets it can be an issue.  Anybody who falls into this situation should be able to choose whether they will or won’t take a particular product, but the report highlights the fact that many people do not realise that their medicines contain gelatine. In particularly, many vegetarians may unknowingly be prescribed medicines that contain animal derivatives.

As such, the authors of the report, published in the Postgraduate Medical Journal are calling for clearer drug labelling for such medicines. Read more »

Last week, FDA Commissioner Margaret A. Hamburg testified before the House Committee on Energy and Commerce, Subcommittee on Health to outline the agency’s case for supporting the fifth authorization of the Prescription Drug User Fee Act (PDUFA), also known as PDUFA V. In addition to offering her support for PDUFA V, Hamburg also discussed renewal of legislation for promoting pediatric drug testing, the need of FDA to invest in science and innovation, and the agency’s efforts in confronting the continual challenges of globalization. In tackling globalization, a basic question arises: does the United States face a pharmaceutical manufacturing disconnect? Read more »

Personalized medicine, which targets individualized treatment and care based on personal and genetic variations, holds much promise for the pharmaceutical industry. Several pharmaceutical majors continue to invest in this emerging field as evident by Roche’s $5.7-billion bid last week for Illumina, a provider of gene-sequencing tools and related analytics. Read more »

FDA issued last week its recommendations for three user-fee programs: the fifth authorization of the Prescription Drug User Fee Act (PDUFA) and new user-fee programs for human generic drugs and biosimilar biological products. The recommendations were transmitted to Congress, which will evaluate the recommendations. Read more »

A new year is often reason to reflect on what has occurred and to consider what the future may hold. And for 2012, Pharmaceutical Technology is doing just that. Next year will mark Pharmaceutical Technology’s 35th anniversary, and as part of a special issue to be published in July 2012, we are seeking to gain your input on what you feel have been the most noteworthy achievements in the pharmaceutical sciences and manufacturing and what future developments may shape the industry. Read more »