Biologics Contract Manufacturing

Biologics contract manufacturing must be safe, reliable, and consistent. In addition, cost efficiency and speed-to-market are key. Therefore, success in biologics contract manufacturing is largely contingent upon technical proficiency and scalability.

The fragility of biological macromolecules, the sensitivity of living cells, and the importance of considering viscosity necessitate advanced technical proficiency, while biopharma company timelines and budgets require timely, cost-efficient scale-up capabilities. Finding the right manufacturing partner who can address these specific challenges truly is vital.

Biologics Manufacturing Company Services

As one of the top biologics contract manufacturing companies in the United States of America, Ascendia Pharmaceuticals specializes in providing its biopharma partners with the expertise, equipment, and resources needed to overcome three main obstacles associated with biologics:

1. Size and complexity
2. Quality of raw materials
3. Efficient scale-up
   
   

In fact, Ascendia is the only contract manufacturer in the United States with the breadth of manufacturing services to overcome some of the most difficult challenges associated with biologics today. We incorporate an advanced microfluidic architecture using special equipment that allows for formulation optimization to be performed while minimizing risk during scale-up to clinical manufacturing.

With an optimized formulation, our team can establish a custom GMP system and then create a seamless transfer from formulation development through manufacturing. So, we can provide end-to-end biopharmaceutical services that span nanomedicine formulation from discovery to commercialization, including pre-formulation, formulation optimization, lead candidate process development, analytical development, scale-up, and technology transfer for cGMP production.

Biologics Manufacturing Process Steps

Any biologics CDMO worth its salt follows these five basic steps in accordance with cGMP practices while maintaining aseptic conditions throughout the biologics manufacturing process:

Step 1. Grow

A growth medium is integral to culture cells outside their native environments. All specialized cell functions are supported by the medium, which also supplies essential nutrients to the cells.

Step 2. Harvest

Harvesting separates the cell culture from the medium. Centrifugation, microfiltration, depth filtration, filtration, and microfiltration are common techniques applied to perform this step.

Step 3. Purify

Impurities such as host cell protein, DNA, adventitious and endogenous viruses, endotoxin, aggregates, and other species are removed during purification. Because biologic drugs are typically administered via injection or intravenous infusion, the importance of testing safety and efficacy in multiple species prior to clinical studies cannot be overstated. Process buffers and detergents introduced during purification also must be removed.

Step 4. Fill and Finish

Fill-finish services are provided once purification is complete. During biologics manufacture, fill and finish is the process of aseptically filling syringes or vials with the biological drug, and then finishing the packaging of the drug for distribution. During the fill and finish of biologics, it takes proven experience and a focus on cGMP to preserve the 3D structures of proteins

Step 5. Store and Ship

The conditions of this final step in the biologics manufacturing process require extra-special consideration, because biological drugs are temperature sensitive. Proven, sound cold chain logistics are necessary to preserve drug substance and drug product integrity.

Biopharma Contract Manufacturing and Beyond

Beyond biopharma contract manufacturing, Ascendia as a company has invested heavily in drug delivery nanotechnologies that aid in biologics formulation development, as well as other large and small molecule formulations. The versatility of EmulSol®, NanoSol®, AmorSol®, and LipidSol helps Ascendia successfully address almost all new compounds with different challenging properties, including biologic products. In fact, Ascendia has generated six patents using its nanotechnologies.

Our ability to provide pre-formulation through Phase 3 manufacturing provides multiple benefits to biological drug development teams. The transfer of experience of knowledge through the pipeline creates cost and time efficiencies.

Contact Ascendia today to explore full-service outsourcing support, including but not limited to the manufacture and release of biologic products ranging from small-scale clinical trial material supply batches to large-scale final dosage form production runs. Not many pharmaceutical contract manufacturing partners possess the knowledge and instrumentation to go from controlled and precise assembly of lipid nanoparticles (LNPs) — by combining optimized precision pumping with the time invariant mixing of microfluidic technology — to preclinical evaluation and beyond.