The growing pipeline of biologics and COVID vaccine production is driving unprecedented growth in the parenteral market. There were close to 500 parenteral drugs in the pipeline as of 2018 and the proportion of which requiring parenteral administration rose by ~2% from 2018 to 2019, according to a Fact.MR report. 

Furthermore, 11.2 billion COVID-19 vaccines were produced in 2021, according to independent data released by the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). This historic scale up of manufacturing of COVID-19 vaccines in just one year demonstrates how CDMOs are uniquely positioned to quickly innovate and provide much-needed manufacturing support. 

Biologics and vaccines require special procedures and equipment for manufacturing and fill finish operations to ensure product quality and safety, giving rise to the need for advanced analytical capabilities and flexible aseptic fill finish technologies. 

According to The Insight Partners new research study, “Pharmaceutical Fill and Finish Outsourcing Market Forecast to 2028 – COVID-19 Impact and Global Analysis By State of Finished Products (Solids, Semi-Solids, and Liquids) and Content,” the pharmaceutical fill and finish outsourcing market size is projected to reach $4.0 billion by 2028 from $2.7 billion in 2021, and is expected to register a CAGR of 6.1% from 2021 to 2028. 

Mike Babics, Vice President of Parenteral Services at Alcami discusses key market trends, vaccine development and production needs, and advances and investments in the parenteral space. –KB  
 
Contract Pharma: What are some of the key factors driving market trends in parenteral manufacturing?
 
Mike Babics: Pharmaceutical and biotech companies worldwide have been increasingly focusing their program development and manufacturing in the anticipated primary markets, which in most cases are the U.S. and EU. Consequently, Alcami and other top 5 most active global sterile drug product contract manufacturers based in the U.S. and EU have been significantly investing in expanding their isolator-based fill-finish capacity for both vials (lyophilization & liquid) and syringes. These investments have been needed to meet the rapidly growing demand for parenteral products and the intensifying regulatory expectations that all sterile manufacturing lines will utilize isolator technology to minimize potential risk to patient safety from the manufacturing process. 
 
The five most active sterile drug product CMO’s, along with Alcami, each manufacture over 20+ global commercial products for a variety of clients, not to mention dozens of clinical programs annually each. Alcami alone anticipates helping clients launch 2 to 3 commercial products annually, across a variety of formats. All of the leading parenteral CMO’s also have capabilities for liquid vials, lyo vials, and liquid pre-filled syringes (PFS).
 
As pharma & biotech portfolios have increasingly focused on rare and ultra-rare indications, they have also experienced increased pressure from the accelerated timelines due to expedited program reviews. To expedite their timelines, they have purposefully sought out CDMO partners that offer extensive formulation and analytical method development which can be rapidly transferred into non-GMP batches for toxicology material followed by GMP manufacturing. These factors, along with the industry consolidation due to mergers and acquisitions, have led to a smaller number of experienced CDMO’s with substantial industry knowledge and the resulting regulatory track record of successful IND’s and PAI’s. 
 
Program sponsors have made it clear that the key drivers for their CMO selection are comprehensive development and analytical capabilities, robust technical expertise, state of the art technology, and the ability (and willingness) to collaborate with the client’s CMC, analytical and program management leadership to enable their program to meet timelines. Alcami has repeatedly found that an experienced and integrated CMO program management team allows for a seamless transition from formulation and analytical development through manufacturing and analytical release, which are of the utmost importance.  
 
CP: How are vaccine development and production needs impacting the industry?
 
MB: There has been a multi-year global shortage of common components, filters, and raw materials, often leading to 30-50 weeks delays. This has been particularly impactful in the CMO industry as many CMO’s were utilizing JIT (just in time) inventory management, so their client’s components would arrive when production was planned to begin, but no sooner. Their goal of having the minimum amount of inventory, due to the high cost of maintaining that supply, has unfortunately meant that many other CMO’s have been unable to meet their clients’ fill-finish needs. Alcami and other leading CMO’s responsible for supplying large numbers of key commercial injectables, fortunately, maintain more extensive inventory stocks than many smaller, less well funded CMO’s that can only work on early phase clinical programs due to their quality systems. Additionally, Alcami also invested in over $15 million of the most commonly utilized components to ensure available inventory options for clients looking to initiate new fill finish projects and is one of the few standalone contracts service providers offering significant scale of analytical depth and capacity for manufacturing, whether it be virtual startups, emerging biotechs, or global pharma clients.
 
CP: What are some key advances with respect to modernization of facilities and/or innovative approaches and processes for parenteral development/manufacturing?
 
MB: Alcami’s newest parenteral manufacturing facility in RTP North Carolina is a testament to the entire industry’s transformation. Quality by Design (QbD) should not apply only to the manufacturing process but should begin with the initial facility design and run through the final product release. Our most recent fill-finish facility was built using the underlying principles of QbD to optimize the design & construction and ensure that it would meet its intended purpose as a parenteral filling facility; This encompassed dozens of key factors, including but not limited to the physical layout, utilities, air handling, and material flow, and many more items before the installation of new isolator technology utilizing single-use-systems, with flexible volume filling offering minimal line loss. This approach is at the core of Alcami’s investment in our new site offering four filling lines for liquid and lyophilized products.