How Governments and CMOs in the West are Preparing to Onshore Essential Medications

The CMO capabilities necessary to ensure supply of essential medications, APIs and medical devices

Posted: February 18, 2021

API Manufacturing and Pharmaceutical Manufacturing

Onshoring of essential medications is bringing business to Western CMOs that are prepared to respond.  After decades of Chinese dominance in API manufacturing, it has become increasingly clear to governments around the world that to assure adequate supply of the drugs North American, European and other world populations depend on, China, and to a lesser extent India, can no longer be trusted to continue supplying the West.  After numerous warnings to government officials from CDMOs, including Seqens CDMO North America about the need to stockpile these medications and protect the supply of raw materials, governments are coming to the realization that protecting public health is a matter of national security and well-being. 

Western CMOs are quickly rising to the challenge and prepared with new techniques such as biocatalysis, skilled project management and hallmark Western entrepreneurship to manufacture drugs that have either never before or not in recent decades been manufactured in the West.  They have also added facilities to meet demand. These factors are contributing to faster drug substance development and manufacturing timelines and, perhaps, consequent cost reductions over time.  

Western governments formulating plans for self-reliance

In the EU, plans are being formulated at the behest of member states who want the EU to draw up with a list of essential medicines and to ensure that the EU is not reliant on countries like India and China for supplies.

TECH TRANSFER

Although this effort had its genesis before 2020, the Covid-19 pandemic’s shortages resulted in a wake-up call across the continent.  With the realization that 80 percent of drugs were being imported from China and India, concern grew rapidly.  Worry about availability of widely used, off-patent, generic drugs; tenuous supply chains, and lack of continental suppliers is resulting in consideration of commercial incentives for EU based production of cheap and low-volume medicines.

The effort will take several years.

The list of essential medications

Similar steps are being taken in the United States.  The FDA has identified and published its list of 227 drug and biological product essential medicines and APIs.  Additionally, 96 medical devices are included on the list, which can be found here.

The essential medications and APIs on the list are considered medically necessary to have available at all times with the goal of ensuring the American public is protected against outbreaks of emerging infectious diseases, such as COVID-19, as well as chemical, biological, radiological and nuclear threats.  To that end, the government will rely on long-term domestic production of these products.  The list also includes medications and various devices that are most needed for hospitalized patients and others with injuries or illnesses.

CMO capabilities play a vital role

Although challenged with supplying governments with a broad range of APIs, medications and medical device components, CMOs with certain capabilities and a great deal of experience and expertise, such as Seqens CDMO, are gearing up to meet the challenge.  Needed capabilities include:

  • Capabilities
    Seven factors to consider in evaluating a CMO’s manufacturing capabilities include the following:
  1. Kilo lab preparation and scale-up
  2. Equipment and facilities
  3. Preventative maintenance program and operator training
  4. Master Batch Records, the key to success in cGMP manufacturing
  5. Cleaning protocols
  6. Warehouse and raw materials
  7. The manufacturing teams

More detail on how to assess each of these can be found here.

  • Capacity
    The world’s largest producer of acetaminophen, Seqens, an integrated global leader in pharmaceutical synthesis and specialty ingredients, exemplifies those CMOs prepared to assure availability of essential medications.  Well before the COVID pandemic, Seqens continued to build capacity worldwide to produce APIs and materials for oral, solid or liquid drug substances and their delivery.  Its plants in Europe, the U.S. and Asia include GMP and non-GMP facilities and are prepared to rapidly scale manufacturing of essential medications. 

    You can find more detail on how to assess these here.
  • Expertise
    Seqens CDMO is known not only for its expertise in chemistry, with its ability to problem-solve the daily challenges of developing and manufacturing new chemistry, but also for its expertise in guiding its sponsors’ projects through US FDA and EU EMA regulatory requirements.   This is reflected in the company’s numerous Leadership Awards over many years for expertise, reliability, service, quality, capabilities and compatibility.
  • Project Management – the Indiana Jones of a CMO
    As we’ve detailed in Successful API Development: Lessons from a CMO,  it’s not unusual to encounter problems in developing new chemistry. There could be an issue with analytics, the chemistry may not be working well, the needed raw materials don’t arrive as scheduled, or they arrive but are of poor quality, and have long-lead items.  It’s not unheard of for these problems to occur simultaneously.  Unflappable, experienced project managers know how to deal with these things and will have a Plan B, Plan C, and even a Plan D for keeping the project on time and on budget. Think of Harrison Ford’s Indiana Jones character, charging through obstacles and vanquishing villains with the end goal, the arc, firmly and always in sight.  This is why we at Seqens revere our project managers. And, like Indiana Jones, they’re good with wielding the proverbial whip too.
  • Equipment
    Having most of the equipment to facilitate just about any project (with some exceptions for very specialized tasks that are best outsourced), is key to maintaining project timelines.  Accordingly, the CMO’s plant should have a mix of equipment with reactors of different sizes and materials of construction.

    It should have different types of equipment to filter and dry the product.

    As well, the plant’s utilities need to reliably deliver a wide range of temperatures and pressures. This variety of equipment and utilities is important to assure that whatever process comes out of the development phase of the project, the plant will be able to handle it.  Initially, it may be difficult to predict what might be needed so having many different options is essential.
  • Specialized techniques
    From biotage to cryogenic chemistry, from micronization to lyophilization, deep expertise in a    variety of specialized techniques within an integrated CMO saves considerable time and money and may speed the effort to manufacture essential medications in the West.  Our staff of PhD-level medical polymer scientists is also critical to that effort. New polymeric materials are essential for creation of the rapidly growing number of    combination products that are becoming so prevalent in pharmaceutical development.  Examples include insulin pumps, drug-eluting stents and a host of innovative drug delivery systems that provide important new therapies for patients – and potential new revenue streams for pharmaceutical companies. 
  • Specialized facilities
    Specialized facilities such as Seqens’ high containment facility and the ability to produce cytotoxic materials also expands the world’s limited capacity to produce the gamut of essential medications. 

    Once manufactured within our own shores, we will have the peace of mind of knowing essential medications will continue to be available whenever needed.

For more information and to connect with our experts in essential medications who work with West Coast-based biotechs, please email Amy.Jacques-Jones@seqens.com.