Founded as a teaching and consulting firm in 2008, AB BioTechnologies, Inc. has steadily expanded its services to include pre-formulation, formulation, analytical and process development capabilities, as well as cGLP production of small-molecule and biologic parenteral and diagnostics products, with particular expertise in lyophilization (freeze-drying). By late 2018, the company will be providing cGMP manufacturing of Phase I-III clinical trial material and small-volume commercial products.
Expanding Lyophilization Services Market
Therapeutic proteins, antibodies and other biologics formulated in solution typically require refrigeration or freezing to retain stability. Maintaining the cold-chain for these drugs can be challenging in many parts of the world. Lyophilization enables the preparation of stable formulations of drug substances that are unstable in aqueous solutions or suspensions; sensitive to heat, oxygen and/or humidity, or formulated at very low or high concentrations, making exact dosing difficult.1 The generated lyophilized powders are shelf-stable and do not require low temperatures for shipping and storage.
While both small- and large-molecule drugs are lyophilized, lyophilization has increased as the number of biologic candidates and approved products has increased. The percentage of new injectable or infusible drugs that were lyophilized grew from just under 12% in 1998 to approximately 50% in 2015.2
Lyophilization is highly complicated, however, involving complex heat and mass transfer processes.3 Customized lyophilization cycles must be developed for each drug and the associated container closure system used. The drug formulation and lyophilization equipment both impact freeze-drying performance, which can also contribute to scale-up difficulties.
Biopharmaceutical companies are, therefore, increasingly relying on contract service providers with specialized lyophilization expertise and equipment. Roots Analysis expects the lyophilization services market for biopharmaceuticals to grow at an annualized growth rate of 9.5% between 2017 and 2027.1 Many contract manufacturers offer lyophilization services, but only a limited number specialize in this technology.
Bloomington, Indiana–based AB BioTechnologies, is one. Our foundation lies in our industry-recognized subject matter expertise in lyophilization and formulation development for chemical APIs, pharmaceuticals, biologics, devices, and tissue-derived products. Formulations and optimized lyophilization cycles are developed at the bench to client specifications, then scaled-up to manufacturing levels. Thermal characterization and analytical development are available as stand-alone projects or integrated into larger projects.
AB BioTechnologies also offers Good Laboratory Practice (GLP) manufacturing services. We can perform your early-stage development work and produce material for your pre-clinical/toxicity studies at one facility, streamlining the path to the clinic.
The percentage of new injectable or infusible drugs that were lyophilized grew from just under 12% in 1998 to approximately 50% in 2015.2
From Development to Manufacturing
We are taking another step to further streamline the path to the clinic by adding small-volume production capabilities in compliance with current Good Manufacturing Practice (cGMPs). With this $12 million expansion, AB BioTechnologies is eliminating the need for tech-transfer projects outside of our facility. We will have the ability to produce cGMP material for Phase I, II, and III clinical trials and small-scale commercial sale.
The new, state-of-the-art, 23,000-square -foot pharmaceutical manufacturing facility includes a manufacturing area for formulating, filling, lyophilizing and packaging drugs. Our current warehouse and development laboratory are being relocated there. Once the plant is completed, AB BioTechnologies will be able to help our clients advance their drugs from concept to clinic under one roof.
Nimble and flexible
AB BioTechnologies is a nimble, flexible company with the express ability to facilitate the development and small-scale manufacturing of parenteral drug products. We can accommodate most types of injectable formulations and welcome projects that require production of 500 to 25,000 vials. Our goal is to help clients get their parenteral medicines into the clinic as quickly as possible, while maintaining exceptional quality.