Bring new drug products to market faster
In a June 2018 interview with McKinsey & Company, Esteban Santos, executive vice president for operations at Amgen, described the current state of the biopharma market and the resulting need for companies to bring new drug products to market faster.
Santos’ view of the market focuses on the role of increasing understanding of the genome and the creation of personalized medicines, intensifying competition and the impending expiry of patent protection on major biologics.
Amgen’s operational response to these conditions is to “supply reliably in a cost efficient manner, but one that is faster to market and has differentiating product features.” For Amgen, this meant creating additional means of differentiation, including “better processes with higher tiers, new manufacturing technologies and improved products with better formulations and delivery devices.”
If operations becomes a competitive advantage in bringing new drug products to market faster, a company has more resources to fund the R&D machine.
This blog will explore how Vanrx’s aseptic processing machines can accelerate drug development, build facilities faster and respond faster to changing market conditions.
Accelerating drug development and clinical trials
Compressing drug development and tech transfer activities to take less time results in drugs reaching the market faster.
Companies can save them time and money on the way to the clinic by completing activities such as formulation, stability, toxicology, and container-closure integrity testing faster. This can be accomplished by using the same processes and technology in the lab and early trials that will be used in production.
Often today drug development occurs with processes and equipment that are dissimilar from clinical trial supply and commercial manufacturing methods. Think of manual aseptic processing under a biosafety cabinet. This is one of the major reasons why tech transfer can be a long and expensive process; you have a great product, but you do not know how to make it yet.
That’s why Vanrx introduced the Microcell Vial Filler . Pharma companies can use the Microcell as early as in the R&D lab, where it supports rapid iterations to new drug products, such as changes to formulations and stoppers, and then for clinical trial batches. The processes and recipes used on the Microcell can then be transferred to the higher capacity SA25 Aseptic Filling Workcell for production fills, dramatically reducing tech transfer activities and time.
Additionally, development candidates and early clinical drug products are often filled in vials, before moving to more clinician and patient friendly pre-filled syringes and auto-injectors later. On the common gloveless isolator platform shared by the Microcell and SA25, the transition to late clinical and commercial production is a much easier process, as the SA25 can produce vials, syringes and cartridges for auto-injectors.
Build and scale facilities faster
“We’ve been able to reduce the time to build and commission a new plant by two years. That allows us to wait longer before making a commitment, giving us time to have more certainty about the forecast before investing.”
– Esteban Santos, Executive Vice President, Operations, Amgen
Amgen is building smaller facilities are 1/5 the size, can be built in 1/2 the time and operate at 1/3 of the cost of traditional biopharmaceutical manufacturing facilities. The company is focusing using production technologies that:
- Have shorter lead times because they are standard items, not custom designed ‘one-offs’;
- Have built-in flexibility for variable batch sizes;
- Save space and cost by intensifying processes.
You can see the full Amgen manufacturing story in this video:
Amgen’s strategy is in response to current facilities not meeting the needs of the company going forward. Think of large 20,000 L stainless bioreactors and high-speed filling lines for processing hundreds of thousands of units a day. Those are technologies for when demand is well-known and a product’s sales are nearly guaranteed for a number of years. They are costly and being custom, often take a long time to order, install and validate.
Vanrx’s Aseptic Filling Workcells fit into the new types of smaller facilities described by Mr. Santos by being standard machines with built-in flexibility. It is possible to order, install and validate a Vanrx SA25 Aseptic Filling Workcell in 12 months or less, and a Vanrx Microcell in six months or less. These are compact machines, requiring smaller spaces than competing technologies, and need only one operator.
A production model using Vanrx machines scales out, not up, by adding standard machines when more capacity is needed. Large biotechs have chosen Vanrx to facilitate their global network strategies and be part of standard production facilities around the world. Validation of new machines becomes a repeatable process, since the organization has worked with the same machine before. By unifying production concepts in various locations, companies can assure that local needs are met, and drug products are safe.
Agility for multi-product manufacturing
“The thing about forecasts is that they are by definition wrong—whether up, down, or sideways—but I don’t know by how much. Agility is a countermeasure to uncertainty. It can improve speed to market and speed in the market when things change.”
– Esteban Santos, Executive Vice President, Operations, Amgen
Bain & Co. estimated that 50% of all pharma product launches in the peak sales range did not meet expectations and half of those missed by more than 50%. The effect of those misses is under- or over-supply, one of which leaves money on the table, and the other results in millions or billions of dollars in inventory.
There is an interesting nuance to Mr. Santos’ comments about “speed to market and speed in the market.” What he’s saying is that agility is a competitive advantage. The shorter the timeframe in which a company can react to changes in the market, the better off they will be.
Speed in market means equipping facilities with technologies that allow them to be agile in producing the needed drug products in the needed formats, and making each at high quality levels. In our infographic about flexible aseptic filling, there’s a weekly calendar showing a different drug product into a different container on each day of the week.
Vanrx designed the SA25 Aseptic Filling Workcell for this purpose—agile production of high-value drugs into different containers. Vanrx eliminated complex format parts, long decontamination cycles and operator interventions through glove ports in order to achieve the required agility. Vanrx designs include a unified method for handling nested containers and closures, and an advanced aseptic process where the sources of risk are clearly identified and constantly monitored. Only Vanrx offers gloveless robotic isolator technology, which is the best sterility assurance available. The balance being struck is between agility, the quality of the drug product supply and the duty of regulators to protect public safety.
Solutions for speed to market and speed in market
This blog explains how Vanrx Aseptic Filling Workcells can help bring drug products to market faster. Companies can build facilities faster and more cost-effectively. Development candidates can move into the clinic faster, and have simpler and faster tech transfer processes. Finally, in launching products and reacting to changing market conditions, companies can react faster and achieve greater commercial success.
Here are some links to our major products to help your search:
Microcell Vial Filler: Drug development, early clinical trial manufacturing and personalized medicines such as cell and gene therapies.
SA25 Aseptic Filling Workcell: Late clinical and commercial filling applications into vials, syringes and cartridges.
Vanrx Liquid / Lyo Workcell System: For late clinical and commercial production of liquid or lyophilized dosages into vials, syringes and cartridges. Automatic robotic loading and unloading of containers ensures safe handling and no product losses.
McKinsey & Company. Operations as a competitive advantage in biotechnology. URL: https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/operations-as-a-competitive-advantage-in-biotechnology. Accessed: September 10, 2018.