Lessons Learned: Choosing & Managing a CDMO

Avéma Contract Services is one of the only Contract Development and Manufacturing Organization (CDMO) that offers integrated, turnkey, end-to-end solutions for Rx, OTC and nutraceutical liquid and solid dose delivery systems. Headquartered in Westbury, NY, Avéma has manufacturing and distribution locations in Miami, Fla., Lynwood, Ca., and Greenville, S.C. Avéma Contract Services is powered by PL Developments.

Flavor Masking for Rx and OTC Drugs

The global gummy vitamin market is expected to reach 10.6 billion by 2025 and gummies are gaining traction as a drug delivery system -- especially for children and seniors who resist taking pills, capsules and liquids. Mitchell Slade, who brings more than 20 years of gummy manufacturing experience at Nature’s Bounty to the table, will address the challenges of developing gummies beyond supplements, such ensuring consistent dosage, production and taste. Avéma/PLD has a world-class GDUFA facility that is CFR 211 and CFR 111 certified, uses a starchless gummy manufacturing process and brings 40+ years of formulating experience to the development of innovative drug delivery systems.

The global gummy vitamin market is expected to reach 10.6 billion by 2025 and gummies are gaining traction as a drug delivery system -- especially for children and seniors who resist taking pills, capsules and liquids. Mitchell Slade, who brings more than 20 years of gummy manufacturing experience at Nature’s Bounty to the table, will address the challenges of developing gummies beyond supplements, such ensuring consistent dosage, production and taste. Avéma/PLD has a world-class GDUFA facility that is CFR 211 and CFR 111 certified, uses a starchless gummy manufacturing process and brings 40+ years of formulating experience to the development of innovative drug delivery systems.

Avéma is leveraging its OTC and Rx drug development expertise into using gummies as a novel delivery system. This White Paper describes what it takes to succeed in this expanding market.

This presentation provides an overview of Avéma Pharma Solution's capabilities.

Looking at the supplement industry as a barometer for drug delivery systems, it’s apparent that gummies are gaining traction as a preferred delivery system. In 2019, the sales of non-pill formats, including gummies, powders and shots, exceeded the sales of pill formats and that gap between the pill and non-pill market share continues to grow.

Avéma Pharma Solutions is building an enhanced, state-of-the-art R&D center that is almost three times larger than the existing space and will help the company respond to increased customer demand for formulation and analytical development.

Avéma Pharma Solutions has made significant investments to enable new capabilities and expand its service offerings going into 2023.

This presentation touches on how Avéma Pharma Solutions helps to eliminate lost time while transitioning from R&D to commercial launch.

Aaron Dely, Avéma's Senior Director of Global Research, gives a tour of Avéma's R&D facilities and discusses how the company's focus on small batches with short turn times around allows for more characterization of the process through design of experiments to support the FDA’s mandate on quality by design. This approach can lead to reductions in review time by the FDA and lead to fewer information requests or a faster approval cycle.