ICH Q11, the anticipated guideline from the International Conference on Harmonization (ICH) titled Development and Manufacture of Drug Substances, has achieved international consensus. Q11 has been one of the fastest guidelines to move through the ICH harmonization process. Q11 was published as a draft in May 2011 and reached Step 4 this month, which means that the ICH steering committee members (representing regulatory and trade organizations in the US, Europe, and Japan), have reached scientific consensus and signed the guideline. At this point, each of the region’s regulatory agencies, including FDA, will publish the guideline as official guidance within their appropriate regions and implementation will begin. Read more »

During the past two years, FDA has been looking more closely at enforcing Part 11 of the Title 21 Code of Federal Regulations regarding electronic records and signatures (see back story). As a result, digital signatures are becoming more commonplace throughout laboratories, manufacturing sites, and offices as companies search for ways to track and file processes, SOPs, approvals, supply chain movement, drug applications, and more. Quality management systems, much like our personal lives, are becoming far more digital and far less paper-based.

PharmTech discusses this issue and related compliance issues in a recent webcast, available on-demand here.

The potential of single-cell genomics took a step forward recently with the announcement by The Broad Institute and Fluidigm Corporation of a new research center focused on developing research methods and discoveries in mammalian single-cell genomics. The Single-Cell Genomics Center is expected to act as a hub for collaboration among single-cell genomics researchers in many fields, including stem cells and cancer biology. Read more »

Guest blog by Justin O. Neway, PhD., Vice President & Chief Science Officer, Aegis Analytical, jneway@aegiscorp.com

More than a year has passed since the FDA issued its guidance, “Process Validation: General  Principles and Practices,” which describes process validation in three stages – Process Design, Process Qualification and Continued Process Verification. Companies are making progress with how to incorporate these guidelines cost effectively for science-based decision making that improves quality–the consequences of poor quality are too costly. Read more »

The world of drug development is littered with early-phase failures: drugs that were shown to be safe in Phase I trials, but which failed to show efficacy later on. The failure of a drug at this early phase might not mean that there’s anything wrong with the compound. Rather, a failure might mean that the mechanism by which the drug acts was not of benefit in the disease against which it was tested. Read more »

FDA’s Lucinda Buhse has been spearheading the agency’s spectral library of excipients as a means to improving supply chain security of the pharma industry, particularly focused on raw materials entering US borders (there are 300 entry points in total). She and Philip Merrill of IPEC wrote about the library last summer in PharmTech and Bushe gave an update on the program at the IPEC ExcipientFest Americas conference in late April 2012..

Hand-held instruments containing the libraries are being used at the borders to rapidly verify and authenticate materials via XRF, IMS, Raman, and NIR screening methods. Materials in question are then investigated at local FDA laboratories.

FDA has been collecting samples from the industry to add to the library but only has about 20% of its most wanted materials (see Table I in the July 2011 PharmTech article) thus far. Incoming materials must match a Hit Quality Index of 0.95. Bushe pointed out that the supplier or site of material used for the library has not had a significant or statistical impact on the library index to date. Samples are therefore being collected from various industry players and from various sites.

Looking ahead, FDA aims to fill its library with all the excipient samples it’s seeking and will work to finalize its classification and modeling strategies.

The pricetag of pharmaceuticals are coming under increasing scrutiny in today’s age of cost constraints. Drug development is expensive and high prices are necessary, but governments and healthcare payers are not always willing to pay the price that pharmaceutical companies are asking.

In the UK, the National Health System (NHS) has taken the controversial step of cutting the cost of treating wet age-related macular degeneration (AMD) by prescribing a cheaper drug over a more expensive one. The controversial element? The cheaper drug isn’t licensed for wet AMD. Read more »

Drug shortages, particularly those for sterile injectable drugs, took center stage last year. In response, industry and the federal government, including FDA, took steps to address the problem. Progress has been made, and Congress is further evaluating if additional steps need to be taken. Read more »

In attending the exhibitions and conference sessions at Interphex 2012 this week in New York, we gain a pulse on the current and future state of pharmaceutical manufacturing. So, a fundamental question arises: what is modern pharmaceutical manufacturing? Read more »

Abbott Laboratories submitted a Citizen’s Petition to FDA, requesting that the agency not consider any applications for biosimilar versions of its monoclonal antibody therapeutic, Humira. Read more »