We’re grateful to be able to attend so many fantastic events this year, and Interphex is no exception!
Our team, will be attending INTERPHEX in NYC (May 24th to 26th), a groundbreaking event that has delivered technology and innovation to the industry for over 40 years!
We’re excited to explore the latest technology, innovation, device development and manufacturing, next week at Interphex
Will you be there? Come by booth 1420 and let’s talk
or book a meeting below
CPhI North America is just around the corner and we’re thrilled to be attending in person May 17th to the 19th and online from the 9th to the 27th of May!
Our team members will be attending, and we can’t wait to learn more about the ever-changing key market trends. From drug manufacturing, sourcing and supply chain, to sustainability and bioprocessing!
Can we expect to see you there? Swing by booth 818 and let’s talk!
or book a meeting below:
Not long now – TIDES USA starts on May 9th will we see you there?
We’re excited to attend one of the industry’s largest and most renowned events for accelerating therapeutics to market.
Our team will be attending (May 9th to 12th) to discuss leading strategies for expediting Research & Development and improving CMC efficiency.
Going to be there? Visit us at booth [number] and let’s talk!
Or book a meeting below:
As a top-tier supplier of injectable grade hyaluronic acid (HA) and provider of specialist full-service CDMO capabilities for complex injectable drug formulations, Lifecore has experienced many fluctuations in the sterile injectable sector.
With over 30 years of experience in the pharmaceutical industry, President of Lifecore Jim Hall discusses the latest trends and challenges facing the sterile injectables market and the qualities pharmaceutical companies should be looking for when choosing their CDMO partners.
Injectables are the fastest-growing portion of the overall contract development and manufacturing (CDMO) market, currently estimated at USD $510.32 million in 2022 at a CAGR of 7.88%.1
With a strong focus on developing treatments for oncology, orphan diseases and personalized therapies, there is a clear demand for more niche and smaller batch capabilities for injectable formulations.
Driving this growth is advancements in sterile injectable delivery technologies, which are vital in bringing new drugs to market and enabling existing drugs to be delivered in a more targeted and safer manner.
These advancements include prefilled syringes (PFS), with demand outpacing the overall injectable devices market. In fact by 2023, PFS devices are expected to account for 77% of all sterile manufacturing revenue.2
Both of these demands require strong and proven quality systems, speed and reliable execution with technical expertise to support all phases of development.
Drug developers must also ensure they have the capacity to support their commercial success for product launch and lifecycle management.
Typically, injectable drug development requires specialized equipment and unique technical expertise and capabilities. Putting these systems in place are the industry’s perennial challenges as many biotech and pharmaceutical companies lack these capabilities in-house.
As a result, an increasing number of pharmaceutical companies are outsourcing their sterile injectables to CDMOs with the expertise, capacity and capabilities to develop and manufacture them.
At Lifecore, we’ve spent over 35 years working with complex drug formulations centered on hyaluronic acid. Across this time, we’ve developed a unique skill set and expertise that transitions perfectly when dealing with other complex high-value molecules.
Our world-class quality system supports customers across every segment of the industry, including active pharmaceutical ingredients (APIs), excipients, biologics, medical devices and combination products.
Our culture is built around providing these critical service components, and we continually invest in our people, systems and infrastructure to deliver for our partners.
Additionally, our teams are subject matter experts in process development, engineering, design assurance, analytical development and manufacturing. Bringing their unique knowledge to each project enables us to assist our customers in bringing their novel drugs to market with entire lifecycle support.
As demand for sterile injectables continues to grow, pharmaceutical companies must ensure they have the right capabilities and processes in place to facilitate their development and manufacture.
This means that we can expect more pharmaceutical companies to explore collaborations with CDMOs who can offer these specialist capabilities and expertise.
In turn, we expect more CDMOs to expand their capabilities as we have here at Lifecore, by expanding operating capacity and development pipelines to support partners as they advance their products.
Discover how Lifecore helps make progress possible for your injectable product.
The big week is almost here – DCAT week starts on the 21st of March!
Organized and hosted by the not-for-profit Drug, Chemical & Associated Technologies Association (DCAT), this annual event brings together some of the greatest players in the bio/pharmaceutical manufacturing value chain, and we can’t wait to be a part of it in New York City.
Are you going to be there? Let’s meet up and make great things happen:
There are several trends set to influence the pharmaceutical sector in 2022.
Many CDMOs, including Lifecore, have already begun adapting by expanding their capacity and cold chain offerings in anticipation.
In this article, we explore the following biotech industry trends and how CDMOs can keep up.
The speed and strength of the US vaccine rollout and advanced developments in novel fill/finish treatments have been hugely impactful for the industry.
The global injectable drug delivery market has seen rapid growth over the past few years, currently forecast to reach USD 510.32 million in 2022 CAGR of 7.88%.
The impact of the Omicron variant of the COVID-19 virus and likelihood of further mutations means that the need for greater fill/finish capacity is set to continue as booster jabs and new vaccines are manufactured.
Research has shown that up to 55% of all drugs in development are injectables, with biotechnology advances such as mRNA therapies, monoclonal antibodies, antivirals, metabolic, cardiovascular, ophthalmics, and respiratory therapies remaining in high demand.
These treatments may also be highly complex to formulate and fill, requiring drug manufacturers to turn to CDMOs such as Lifecore who have the capabilities to meet these complex commercial manufacturing requirements and those of lesser complexity as well.
In 2001, there were just over a thousand companies with active R&D pipelines across pharma and biotech. By 2020, this figure had reached over 5,000.
In addition, up to 75% of new drug development in small to midsize pharma has been outsourced in the past decade.
As a growing proportion of investigational therapies sponsored by smaller and or/virtual pharma companies progress through preclinical phases and prepare for trial, they will often lack the experience or capacity to manufacture increasingly complex new investigational therapies, which leads to a greater rate of outsourcing.
These complexities often include overcoming bioavailability challenges, which invariably results in highly viscous products, which require highly specialized fill/finish capabilities to manufacture.
Pharma companies developing these therapies must adapt by outsourcing to CDMO partners, such as Lifecore, that have the technical expertise, knowledge, infrastructure and culture to handle these complexities.
The global pandemic exposed the fragility of global supply chains, with the US government among many who have ramped up their incentives to onshore critical pharmaceutical supplies in response.
This is set to continue into 2022 and beyond, with pharma companies likely to drive greater demand for domestic capacity. This means that those currently relying on supplies from international partners may need to rethink their partnerships for more localized support.
Looking ahead for 2022
While the past two years of the COVID-19 pandemic highlighted fragilities in the pharmaceutical supply chain, we have also seen increased innovation across the pharmaceutical industry.
As a full service CDMO specializing in complex and difficult to formulate drug products, Lifecore is equipped to support the industry’s pioneers in making their progress possible from three state-of-the-art CDMO facilities in Chaska, MN.
Explore our services to discover how we can take your drug product from preclinical development through to commercialization.