Batch manufacturing has been the traditional mode of manufacturing in the pharmaceutical industry for more than a generation now, but times are changing and more and more Contract Development & Manufacturing Organizations (CDMOs) are embracing continuous, or flexible manufacturing alternatives. But as with most things, there is a time and a place for everything, and while continuous manufacturing is growing in importance, it’s not quite time to send batch processing packing.
Continuous vs. Batch Manufacturing
With batch technology, the ultimate finished product is developed in a series of steps, which must be completed before a new batch can be processed. Using this method, CDMOs can produce specific amounts of a certain product and then adjust their manufacturing priorities according to the changing demands of the market.
A benefit of batch production is that the set-up costs are typically modest, and each batch is more easily tailored to be unique. There are also certain drugs that can only be manufactured in batches because of their composition.
In addition, batch processing can be more cost effective. The pharmaceutical industry is filled with a variety of drugs under development with limited or unknown likelihood of clinical and commercial success. For products like these, it’s unrealistic for companies to take a gamble on the huge investment (upwards of $4-5M) that continuous manufacturing requires.
With batch processing, there also may be more flexibility if a company needed additional capacity. Because a continuous production line is designed specifically to process one specific drug, it may not be possible, to switch processing easily to another drug that requires a different process.
So, batch processing will continue to serve a need in the marketplace for the foreseeable future. The cost of building special cGMP suites dedicated to the manufacture of a specific drug is unrealistic for most firms, unless it’s a blockbuster drug that requires continuous and fast production, and which will continue to have huge demand in the market.
Despite the continued benefits of batch processing, continuous manufacturing is on the rise. It enables a CDMO to take a drug from raw materials to final product – seamlessly – with no need to shut down equipment or have any down time as the product is created.
In addition, continuous manufacturing, which is GMP compliant, consumes a smaller physical footprint, which helps it to be a more environmentally friendly option. The risk of human error is also reduced because continuous processing means fewer people are involved in the production process from start to finish.
The U.S. Food and Drug Administration (FDA) estimates that some drugs which normally take a month to produce using conventional batch processing, may only take one day to make using continuous manufacturing. This flexibility enables product to be produced in response to market demand (just-in-time) rather than the sponsor having to maintain large inventories in case of demand surges.
Another key benefit is that continuous manufacturing does not compromise quality. By eliminating breaks between steps, it can reduce opportunities for human error.
Below are some key trends driving the growth of continuous manufacturing:
Fast-tracked drugs. Many new therapies are receiving fast track, or Breakthrough Drug status, which allows them to take a much shorter clinical development path to FDA approval. Continuous manufacturing can help CDMOs significantly speed up the chemistry and manufacturing processes.
Personalized medicine. New drugs can be highly targeted and potent, so the amount needed is often much smaller than traditional ones. The high price and novelty of these treatments can make it difficult to predict market demand and the amount that must be manufactured.
FDA guidance. The FDA recently came out with guidance to support flexible approaches to the manufacture of quality pharmaceutical products. The guidance encourages the development of emerging technology which may lead to pharmaceutical innovation and modernization, such as “a more robust drug product design and improved manufacturing with better process control, thereby leading to improved product quality and availability throughout a product’s lifecycle.”
The need for flexibility in manufacturing technologies has never been greater. New drugs can be more precise and powerful, produced in smaller volumes, yet subject to great market uncertainty. While continuous manufacturing will increasingly play a greater role in large-scale commercial manufacturing, for early-stage development, batch processing will continue to be the de facto manufacturing process at least for the short term. The key is for manufacturers to explore all processes and be open to new innovations, while taking a realistic approach to ensure the most effective, practical and cost-effective route to pharmaceutical manufacturing.
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