Halo Pharma has extensive experience in clinical trial drug product manufacturing for tomorrow’s most important medicines.
Halo Pharma has over 10 years of clinical and commercial scale contract drug product development and manufacturing experience with multinational and large pharma companies.
Halo’s leadership team has over 200 years of combined experience in drug product development and manufacturing. We partner with our clients to provide technical development solutions to address the increased pressure to meet pipeline timelines and budgets.
Halo Pharma has successfully supported over 100 new product launches in the past 10 years.
We support 8 of the top 10 large pharmaceutical companies by market cap and have developed and manufactured products for more than 20 NDA applications. At any given time we have over 20 active clinical stage products in our Product Development Services pipeline so our scientists and technicians are constantly refreshing their expertise in working with some of the most challenging molecules. Many Large Pharma clients work with us for line extensions in particular, for pediatric indications.
A Focus on Trust and Partnership
We partner with our clients to provide technical development solutions to address the increased pressure to meet pipeline timelines and budgets. We can provide expertise in the development of drug product candidates and commercial technical transfers that cover a wide array of therapeutic areas for adult and pediatric dosage forms including orphan drugs with particular expertise in cardiovascular, CNS, dermatologic and pain management products
We provide our clients flexible, quality led development and commercialization solutions with specialization in the development of:
- Poorly Water Soluble Drugs using state of the art Hot-Melt or Twin Screw Extrusion Technologies
- Difficult to formulate, high dose anti-infective products using our extensive roller compaction capabilities
- Pediatric Drug Products including Mini and MicroTablets, Pellets Beads, Powders, Capsules, Stick Pack and Liquid Suspensions
- Topical Sterile and Non-Sterile Semi-Solid Ointments, Gels & Creams
- Pain & Abuse Deterrent dosage forms including Modified Release Controlled Substances (CI-CV) and Fixed-Dose Combination (FDC) products
- CNS products including Bi-Layer and Orodispersible tablets and with specific capabilities in Granulation/Wurster coating including the use of solvents
We have developed many difficult to formulate drug products and provide bioavailability solutions to meet critical clinical endpoints.
Our Large Pharma Partners benefit from a single Project Team providing continuity as products progress through the following stages that include:
- Analytical Development, Transfer and Validation Activities
- Drug Development and Formulation Technical Transfer
- Manufacturing Non-GMP Laboratory Batches & Stability Programs
- QbD Optimization Batches
- cGMP Pilot Batches (Pharmacokinetics-Bio Batches)
- cGMP Pivotal Batches (Bioequivalence Batches)
Our integrated pharmaceutical development solutions are customized to focus on your program needs, which can include:
- 505 (b) (2) pathway for oral modified specialty products
- Orphan drugs for rare diseases
- Technical Transfer of in-licensed late stage products
- New indications or novel drug delivery formulation of exiting products
- Product Line-Extensions (Pediatric dosage form for an Adult dosage form)