Introduction

Unlike most of the drugs which are manufactured in an ordered process through chemical synthesis, biologics involve large and complex molecules that are heat sensitive and susceptible to microbial contamination and require aseptic principles throughout the manufacturing process. Therefore, for biologics, “the product is the process.”

Over recent decades, protein-based therapeutics have emerged as key drivers of growth in the pharmaceutical industry. Drug development pipelines have filled with biologics, and a handful of monoclonal antibody (MAb) products have become some of the best-selling drugs around the world.

Market Info:

With 12 of the 45 NMEs approved by the FDA in 2015 being BLAs (Biologics License Applications), the biologics market is growing at 10–11% year over year and is set to increase its market share from ~17% in 2016 to ~23% in 2021 of the entire pharma sales. With 7 classes, 12 molecules and 20 brands so far, the European pharma biosimilar market is the most advanced.

The biologics CMO market, which currently stands at $5.3bn, is expected to grow at 8.3% in the near future. With 75% of clinical and 85% of commercial biopharma supplies being outsourced, the CMO-based Fill-Finish industry has also been growing at the same rate as overall biopharma manufacturing, i.e., 10%-15% annually particularly in the U.S. market.

Biologics Fill and Finish – Challenges:

Fill–finish operations must be designed with an awareness of the innate properties of proteins and external factors that can affect a given protein’s behavior and stability. Special processes, procedures, and equipment must be in place to ensure product integrity during fill–finish manufacturing.

• Handling of sensitive biologic products
• Inspection of clear and opaque suspensions
• Inspection of amber vials
• Distinguishing between foreign and product-related particulates

Owing to these complex manufacturing tasks, most of the manufacturers have consistently increased their outsourcing activities:

Top activities being outsourced:

• Bioassays
• Toxicity testing
• Fill/finish operations
• Validation services

Fill-finish operations are the most heavily outsourced, with an estimated average of 35.6%. Fill-finish is the only area in which at least one-third of all activities are performed by contract manufacturers, indicating that while more companies are engaging in outsourcing, few are doing so heavily.

Higher Fill/Finish Outsourcing:

The fill/finish industry will likely depend on ramp-up of technologies and capabilities both in-house and at CMOs.

• Fill and finish CMOs are becoming larger, through mergers and acquisitions
• CMOs will continue to install state-of-the-art fill/finish equipment, mostly to support clinical manufacturing. Biopharmaceutical CMOs will do less sub-contracting of their fill and finish to specialized CMOs
• Fill-Finish CMOs in India and rapidly developing countries are handling increasing amounts of biopharmaceutical products, mostly for domestic and lesser-regulated international commerce

Piramal Services:

Piramal Pharma Solutions offers development and manufacturing of sterile injectable products from its FDA approved facility in Lexington, KY in USA. It offers services from clinical trial to commercial-scale development & manufacturing of sterile liquid and lyophilized injectables, and has special capabilities to handle high potent and cytotoxic compounds. Our manufacturing facility utilizes isolator technology for aseptic processing. We provide fill/finish services for sterile injectables and ADCs from our facility in Lexington, KY.

Our Offerings:

• Fill/Finish Services for:
  • Sterile Injectables & Depot
  • In-situ Salt Formations
  • Nanoparticles & Liposomes
  • PEGylated and Lyophilized products
• Biologics – A wide variety of both liquid and lyophilized biologics can be Fill/Finished:
• Proteins and Peptides
• Monoclonal Antibodies (MAbs)
• Antibody Drug Conjugates (ADCs)
• Hormones