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  1. Avéma Pharma Solutions
18 August 2021

Avéma Pharma Solutions Announces Plans for Expansion of Miami R&D and Manufacturing Capabilities

 

As pharma and biotech companies increasingly turn to Contract Development and Manufacturing Organizations (CDMOs) as extensions of their development and manufacturing departments, Avéma Pharma Solutions will be investing in both human capital and equipment to meet the demand. The full-service CDMO has announced plans to invest in new manufacturing equipment to produce solid-dose products, adding additional granulation and encapsulation suites, purchasing more analytical equipment, and adding headcount in R&D and manufacturing. The company also recently expanded its liquid manufacturing capabilities and added full on-site serialization capabilities to its packaging lines.

Avéma’s Miami 90,000 square foot FDA-registered and cGMP-compliant pharmaceutical manufacturing and research facility offers complete, turnkey solutions including R&D, product development, validation, testing, demonstration batches, small-scale manufacturing, and transfer to commercial levels. The company has more than 30 years of Rx formulation development experience and offers a wide range of product capabilities, including small-volume pilot scale production capabilities, high-potency compounds and small molecule drug development, as well as designing drug delivery systems for poorly-soluble compounds. The facility includes a comprehensive analytical laboratory, pilot scale manufacturing, and extensive commercial launch capacity in tablets and capsules, producing 5.5-6 billion units annually.

Avéma’s ability to offer integration between R&D development and commercial manufacturing, and its commitment to Design of Experiment (DOE) techniques supports the FDA’s mandate on quality by design, which can help reduce FDA review time. This streamlined approach helps companies accelerate R&D and efficiently transfer to commercial production quickly and cost effectively, often cutting four to eight weeks out of traditional timelines.

To ensure the seamless transition from pilot manufacturing, Avéma uses small-scale production equipment in the development process that has identical specifications to what will be used in full-scale commercial manufacturing, rather than bench top or pilot manufacturing equipment, all under the supervision of a single project manager to ensure that no information is lost during scale up.

Learn more at our website: www.avemapharma.com. Avéma Pharma Solutions is a division of PL Developments.

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