The International Conference on Harmonisation’s Planned Drug Manufacturing Guideline: What Do Pharma Manufacturers Need To Know?

By Jennifer

International Conference on HarmonisationThe International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is an organization that brings together pharmaceutical regulatory authorities in Europe, Japan, and the United States towards the goal of standardizing processes for safe and effective drug discovery and development. On October 10th, 2014, ICH published an initial concept paper for guidance in its Quality category titled ”Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.” The resulting ICH Q12 guideline, due to be available in 2017, will complement existing quality assurance plan guidance in the pharmaceutical development and launch phases with regulatory recommendations in the later chemistry manufacturing and controls (CMC) phase. Adoption of ICH Q12 will benefit patients, pharmaceutical/ biotech companies, and regulators through continual improvement of post approval processes. So what should you do?

In this article, we will review the concept paper as well as to begin to highlight how the 3DEXPERIENCE Platform and the Licensed to Cure for BioPharma industry solution experience can help you prepare for, and implement the ICH Q12 guidance. We will follow the ICH Q12 updates closely on the blog, see all posts tagged with ICH here.

Licensedd To Cure For BioPharma

Representation of the solution (example).

While ICH Q12 is a very fitting addition to the organization’s Quality guidelines, the concept paper makes it clear that creation of the guideline is due to unforeseen gaps in the implementation of  ICH Q8-Q11, which are as follows:

 

The ICH Q12 guideline is expected to impact the following areas

  • Regulatory Dossier
    • Updates aimed at improving post approval changes
  • Pharmaceutical Quality System (ICH Q10)
    • Develop improved knowledge and change management systems
  • Post-approval Change Management Plans and Protocols
    • Establish criteria for managing and submitting post-approval changes

 

The benefits of ICH Q12 implementation include

  • Improving reliability of the supply of pharmaceuticals through more CMC change management processes
  • More standardized and useful regulatory dossiers
  • Enhance use of regulatory tools for Post-approval Change Management (PACM)
  • Continual improvement of the manufacturing process
  • Reduction of product variability
  • Increased manufacturing efficiency

 

The benefits of product lifecycle management

At Dassault Systèmes (3DS), we have long recognized the benefits of product lifecycle management in improving the drug manufacturing process and ultimately the patient experience. The Licensed to Cure for BioPharma industry solution experience powered by the 3DEXPERIENCE platform combines advances in collaboration, global product development, and information intelligence to provide operational excellence. This single version of the truth, systematic  approach to drug manufacturing fits well with the ICH Q12 vision, and we look forward to working with biotech and pharma manufacturers to guide them in adapting to these changes. You can learn more about 3DS pharma and biotech solutions by attending the 3DEXPERIENCE Forum—North America, taking place November 12-14, 2014 in Las Vegas.

The ICH Q12 guideline will represent a major change as it will be applicable over the lifecycle of the product and focused on the CMC phase. An Expert Working Group (EWG) will be comprised of assessors and inspectors with expertise in quality systems and pharma manufacturing of chemical, biological, or biotechnological products. The EWG will meet in November 2014, June 2014, and November 2015, with the Adoption of Step 2 Document occurring in Q2 of 2016 and Adoption of Step 4 Document occurring Q2 2017 (see this description for details of the ICH process). Although not all regulatory authorities (such as the Food and Drug Administration, (FDA)) adopt the ICH Guidelines directly, ICH Q12 will surely impact regulatory requirements globally.

Medical engineering’s future frontiers

By Catherine

By Catherine Bolgar*

Future technology to detect and treat diseases is coming from some surprising sources. We talk about “fighting diseases” or “fighting cancer,” for example. Well, how about using military technology for medical devices?

medical device

MelaFind, which is already on the market, uses innovative spectral imaging and software-driven technology born from missile-navigation systems to help dermatologists detect melanoma at its most treatable stage.

Melanoma accounts for only 5% of all skin cancers but is responsible for 75% of deaths. Caught early it’s almost 100% curable; however, by the time melanoma goes more than 1mm below the skin, patients have a 50% chance of dying, usually within a year.

“Dermatologists are probably the last group of physicians who don’t use imaging as a standard,” says Rose Crane, chief executive and president of MELA Sciences, the Irvington, New York, company that makes MelaFind. While dermatologists are very good at spotting melanoma vs. benign moles, many cases are difficult and ambiguous for them, she says.

MelaFind uses spectral light to illuminate the skin, and then provides the doctor with 3D images, as with magnetic resonance imaging. Then, the images are analyzed with proprietary algorithms that provide the doctor with data on the probability of the lesion being a melanoma based on the largest positive, prospective study ever conducted on the disease.

It’s able to non-invasively image and analyze irregular moles 2.5mm below the skin surface where a doctor can’t see unless he/she cuts,” she says.

Near-Infrared Fluorescence Lymphatic Imaging (NIRF-LI) is another device that uses military technology for medical imaging. NIRF-LI stands for “near-infrared fluorescence lymphatic imaging,” and uses infrared military-grade night-vision technology to see the body’s lymphatic structures and flow for the first time.

Watching television coverage of nighttime operations during the first Gulf War, Eva Sevick-Muraca, now professor of molecular medicine at the University of Texas Health Science Center at Houston, or UTHealth, recalls that she “had the crazy idea that we could use near-infrared fluorescence for medical imaging. We don’t have any natural molecules in the body that fluoresce at these wavelengths, but if we could find a molecule that does and use it as a contrast agent, we could use harmless light for medical imaging.”

Indocyanine green, or ICG, fluoresces when illuminated with near-infrared light. Once a tiny amount of ICG is injected into the skin, the lymphatics draw the dye into the lymphatic vessels, through regional lymph nodes and beyond. When dim laser light illuminates tissue surfaces, the dye “lights” up, and NIRF-LI enables visualization of the ICG moving through the lymphatics, explains John Rasmussen, assistant professor at UTHealth. NIRF-LI can take pictures of this so quickly that it can image actual lymphatic flow.

The device is important because the lymphatics play a role in many diseases and conditions that are becoming more prevalent, including cancer, lymphedema, autoimmune diseases, asthma, chronic wounds, vascular disease and others.

Doctors typically check lymph nodes for cancer when removing tumors, but lymph nodes aren’t in exactly the same places in each person, so surgeons have to hunt for them. Once found, the lymph nodes are removed for biopsy to see whether they are cancerous. Eventually, using cancer-targeted imaging agents, NIRF-LI could be used for “image-guided lymph node dissection,” says Dr. Sevick, to determine whether they are cancerous before removing them.

Drs. Sevick and Rasmussen hope that they and their industrial partners, NIRF Imaging Inc., based in Montgomery, Texas, and Exelis Inc. of McLean, Virginia—the leading supplier of military night-vision goggles—will have NIRF-LI on the market as soon as next year.

Other futuristic devices aren’t linked to military technology. The MINIR robot, being developed by Jaydev P. Desai, professor of mechanical engineering and specializing in robotics at the University of Maryland, can remove brain tumors while causing minimal damage to healthy tissue. The robot is made of plastic so that it can be deployed in the brain while the patient is in a working MRI machine. A physician would view the brain and the robot on the MRI interface, and remotely control the robot toward the tumor. The robot would then electrocauterize the tumor and be guided back out.

The robot, whose prototype resembles a small finger, is called MINIR for “Minimally Invasive Neurosurgical Intracranial Robot.” Some tumors can’t be reached by common surgical approaches. “When surgeons try to get to a tumor, in the process you may cause trauma to normal brain tissue,” Dr. Desai says. “Our challenge is can we get to that location while minimizing the trauma and then can we get the tumor out.”

Another device Dr. Desai is working on is a special catheter. Physicians now use a catheter, which is thin and flexible, to get into the body, for example, into a vein.

What if you had the ability to control how to bend a thin robotic catheter with an integrated diagnostic or therapeutic device or both,” he says.

This steerable, robotic catheter could send in an optical coherence tomography probe for diagnostic imaging. That would let a surgeon better see what is happening inside the body. A catheter that can bend at a surgeon’s will “can get around structures in the body that you want to avoid,” Dr. Desai explains.

*For more from Catherine, contributors from the Economist Intelligence Unit along with industry experts, join The Future Realities discussion.

Are your Manufacturing Processes at Maximum Efficiency?

By Diana

Can you answer YES to these questions…?

  • Do you manage to produce more and faster without increasing the risk of error in your quotations and delivery? Manufacturing process
  • Do you capitalize on your knowledge and best practices and reuse existing elements?
  • Do you have traceability throughout the product’s development process from start to finish?
  • Can you provide your customers with tailored machines that meet their specific needs?
  • Are you able to work and fully cooperate with all your stakeholders around the world on the same project?

If you’ve answered YES to all these questions, your manufacturing process is perfect and you have nothing to do here! Why not share your best practices with us?

However, If you’ve hesitated before answering or even answered no to some questions, you should probably keep reading.

In order to transform your company into a more efficient manufacturing organization and say YES to all questions above, there are a few things you need to know:

The 4th Industrial Revolution

In the age of the 4th Industrial Revolution, a new way of thinking from design to manufacturing is impacting industrial equipment companies.

 

The 4th Industrial Revolution is all about Social, Smart and Flexible production with high value added services.

No need to worry, all this is new, so you haven’t missed anything!

However if you’ve responded YES to some of the questions, then maybe your company is using an Engineered-To-Order (ETO) approach, which is costly and complex. There are lots of solutions to improve and optimize this ETO process.

Here are some key points you may not want to miss…

  • Transform your product architecture into a modular one
  • Develop a strategy to reuse items and best practices
  • Empower all disciplines of the company to work together at the same time on the same project

Still not convinced? Find out more about improving your manufacturing processes,
in our free on-demand webinar here.



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