Tim Wright, Editor, Contract Pharma02.26.21
CoreRx is a contract development and manufacturing organization (CDMO) with capabilities to support clinical through commercial manufacturing. Its integrated offerings provide comprehensive services for the development, manufacturing, and testing of solid, liquid and semi-solid dosage forms. Contract Pharma recently spoke with Mark DaFonseca, chief business officer at CoreRx about oral solid dose market and technology trends.
Contract Pharma: How would you describe the current state of the oral solid dose manufacturing market?
Mark DaFonseca: The oral solid dosage market is still strong. It is still one of the most patient friendly dosage forms available. About 60% of the projects we do are oral solid dose, and this has been fairly consistent for the last 5 years. The focus is primarily on small molecules however, we have seen an increase in the need for oral solid dosage forms for proteins and peptides.
Contract Pharma: What’s new on the oral solid dosage front at CoreRx?
DaFonseca: CoreRx has been continuing to invest in our campus in Clearwater, FL. We doubled our manufacturing capacity in 2019 by building out a portion of our ML2 building for small scale manufacturing and packaging, allowing our ML1 building to be focused on larger scale manufacturing and packaging for late phase and commercial programs. ML1 becomes the second building on our campus that we perform commercial manufacturing in, as our third building, ML3, is dedicated to one our clients for commercial manufacturing and testing.
A rendering of the new CoreRx campus in Clearwater, FL. Headquarters are located at ML1.
In 2020, we completed an expansion into our new 26,000 sq. ft. Product Development Center of Excellence where we support solid dosage form development, as well as have a dedicated lab for in vitro screening of drug permeability. In addition, we recently brought online our new Mobile Minor unit to continue supporting cGMP manufacturing of spray dried dispersions as part of our bioavailability enhancement technologies.
We feel we have positioned CoreRx now as a premier CDMO that can support clients from early phase through commercial manufacturing, offering end to end solutions across a variety of technologies on a single campus. Providing the small Pharma sector the development expertise, speed and flexibility they need, in a CDMO they can now stay with for commercial support, is something we have seen great interest in from the market.
Contract Pharma: What are some key trends driving the contract solid dosage business?
DaFonseca: In 2020, there was a push to get non-vaccine products for treating hospitalized patients with Covid into the clinic. We were fortunate enough to have at least one of those products successfully complete Phase I and move into Phase II. There is in general still a large need for pediatric dosage forms. While most of these are oral liquid dosage forms, there is a lot of interest in alternative dosage forms such as dispersible tablets, mini-tablets, and sachets.
We also saw more projects than ever starting with either a powder in capsule or powder in bottle for reconstitution approach for Phase I. It seems the whole market has decided this is the fastest way to get into the clinic. And while this may be true, it isn’t necessarily the best way to go for products with special needs such as a high dose, delayed or extended release. In the long term, it pays to get some formulation work done towards a final dosage form early in the process.
Contract Pharma: Where are the current opportunities for growth?
DaFonseca: There is still an unmet demand in bioavailability enhancement of molecules. Having a variety of formulation and technology approaches to help solve those problems, and tools to assess their effectiveness, will allow an organization to set themselves apart. We are increasingly using in vitro permeability screening to identify the factors important for a products bioavailability.
Contract Pharma: Conversely, what are the challenges and/or obstacles in the market?
DaFonseca: One of the major challenges we are experiencing since the pandemic hit last year is significant delays in the receipt of raw materials and packaging components. A lot of resources got diverted to Covid activities making it a challenge to get projects started and keep to original timelines. Getting sufficient active ingredient (API) to work with during development remains a challenge as does getting a consistent API to work with. Polymorphic and morphologic changes of the API during scale-up are a constant problem that we face.
Contract Pharma: What are the most recent advances in oral solid drug delivery technology?
DaFonseca: Spray granulating of nanoparticles, spray congealing of lipid particles, microfluidization, and hot melt granulation are some of the techniques we’ve been able to put into practice to improve bioavailability.
Mark DaFonseca, Chief Business Officer, CoreRx
Contract Pharma: How would you describe the current state of the oral solid dose manufacturing market?
Mark DaFonseca: The oral solid dosage market is still strong. It is still one of the most patient friendly dosage forms available. About 60% of the projects we do are oral solid dose, and this has been fairly consistent for the last 5 years. The focus is primarily on small molecules however, we have seen an increase in the need for oral solid dosage forms for proteins and peptides.
Contract Pharma: What’s new on the oral solid dosage front at CoreRx?
DaFonseca: CoreRx has been continuing to invest in our campus in Clearwater, FL. We doubled our manufacturing capacity in 2019 by building out a portion of our ML2 building for small scale manufacturing and packaging, allowing our ML1 building to be focused on larger scale manufacturing and packaging for late phase and commercial programs. ML1 becomes the second building on our campus that we perform commercial manufacturing in, as our third building, ML3, is dedicated to one our clients for commercial manufacturing and testing.
A rendering of the new CoreRx campus in Clearwater, FL. Headquarters are located at ML1.
In 2020, we completed an expansion into our new 26,000 sq. ft. Product Development Center of Excellence where we support solid dosage form development, as well as have a dedicated lab for in vitro screening of drug permeability. In addition, we recently brought online our new Mobile Minor unit to continue supporting cGMP manufacturing of spray dried dispersions as part of our bioavailability enhancement technologies.
We feel we have positioned CoreRx now as a premier CDMO that can support clients from early phase through commercial manufacturing, offering end to end solutions across a variety of technologies on a single campus. Providing the small Pharma sector the development expertise, speed and flexibility they need, in a CDMO they can now stay with for commercial support, is something we have seen great interest in from the market.
Contract Pharma: What are some key trends driving the contract solid dosage business?
DaFonseca: In 2020, there was a push to get non-vaccine products for treating hospitalized patients with Covid into the clinic. We were fortunate enough to have at least one of those products successfully complete Phase I and move into Phase II. There is in general still a large need for pediatric dosage forms. While most of these are oral liquid dosage forms, there is a lot of interest in alternative dosage forms such as dispersible tablets, mini-tablets, and sachets.
We also saw more projects than ever starting with either a powder in capsule or powder in bottle for reconstitution approach for Phase I. It seems the whole market has decided this is the fastest way to get into the clinic. And while this may be true, it isn’t necessarily the best way to go for products with special needs such as a high dose, delayed or extended release. In the long term, it pays to get some formulation work done towards a final dosage form early in the process.
Contract Pharma: Where are the current opportunities for growth?
DaFonseca: There is still an unmet demand in bioavailability enhancement of molecules. Having a variety of formulation and technology approaches to help solve those problems, and tools to assess their effectiveness, will allow an organization to set themselves apart. We are increasingly using in vitro permeability screening to identify the factors important for a products bioavailability.
Contract Pharma: Conversely, what are the challenges and/or obstacles in the market?
DaFonseca: One of the major challenges we are experiencing since the pandemic hit last year is significant delays in the receipt of raw materials and packaging components. A lot of resources got diverted to Covid activities making it a challenge to get projects started and keep to original timelines. Getting sufficient active ingredient (API) to work with during development remains a challenge as does getting a consistent API to work with. Polymorphic and morphologic changes of the API during scale-up are a constant problem that we face.
Contract Pharma: What are the most recent advances in oral solid drug delivery technology?
DaFonseca: Spray granulating of nanoparticles, spray congealing of lipid particles, microfluidization, and hot melt granulation are some of the techniques we’ve been able to put into practice to improve bioavailability.
Mark DaFonseca, Chief Business Officer, CoreRx
