Industries and Markets

Biologics manufacturing is a very long and expensive process with final products offered at high price points. Fill finish is the last step of manufacturing  and is the most critical and value added step supplying to clinics, hospitals, and patients. Demand for fill finish is very high due to low capacity, high facility CAPEX/OPEX, and expected to increase from higher number of regulatory approvals of novel biologics and biosimilars.

Ascent Pharma Solutions is established as key resource for companies in the Biopharmaceutical Industry leveraging the competence, knowledge and experience of the experienced team that is assembled. In-depth capabilities in Fill and Finishing manufacturing segment is another of our unique strength.

Biopharmaceuticals

Biopharmaceuticals are large and complex molecular drugs that are mainly obtained from proteins and nucleic acids of living organisms such as microorganisms and animal cells also known as transgenic organisms. These drugs produced and synthesized using biotechnology processes are usually administered by intravenous, subcutaneous, or intramuscular injections and are more efficient than the conventional small molecule drugs.

Biopharmaceuticals are effective alternative to many previously less effective and sometimes unsafe treatments. They usually are highly effective and with potent action, have fewer side effects, and can be tailored according to specific medical requirements of patients. Biopharmaceuticals had reduced deaths due to cancer and HIV/AIDS in the past decade and have revolutionized treatment of several chronic diseases, such as diabetes and cardiovascular diseases.

Some of the biopharmaceuticals include monoclonal antibodies, erythropoietin, growth hormones, recombinant proteins, recombinant human insulin, purified proteins, interferon, and vaccines. Recombinant human insulin was amongst the first substances to be approved for therapeutic purpose, and currently, there are nearly 300 biopharmaceutical products which have been approved and are available in the market.

The global biopharmaceuticals market is anticipated to be valued at $278.2 billion by the year 2020. The market is expected to advance at a CAGR of 9.6% during the forecast period. Greater acceptance of biopharmaceuticals to treat a range of diseases is a prominent factor for the growth of this market

Despite the attractiveness of this market, biologics manufacturing is a very long and expensive process with complex and highly regulated requirements. This is coupled with stringent environment control, high regulated process control as well as in-process and material quality management. Challenges in production scale-up, process optimization, documentation, validation and process monitoring are constantly on the mind of the Biotech companies. Speed to Market, Process Economics as well as regulatory compliance are key factors of success to win in this lucrative market.

Fill Finish

Fill finish is the last step of pharmaceutical manufacturing. It is the most critical and value-added step for the drug product supplying to clinics, hospitals, and patients. It is an essential process step which is highly regulated to guarantee the safety and efficacy of the final drug product. It is key to ensure and maintain sterility of components, production areas and equipment. The fill-finish manufacturing includes the moving, manipulation, and packaging of solid and liquid dosage forms.

As per the report published by Fior Markets, the global fill-finish manufacturing market is expected to grow from USD 6.81 billion in 2019 and to reach USD 14.81 billion by 2027, growing at a CAGR of 10.2% during the forecast period 2020-2027. Demand for fill finish is very high due to low capacity, high facility CAPEX/OPEX and also due to the expected higher number of regulatory approvals of novel biologics and biosimilars.

Many factors attributed to this include increasing technological advancement in fill-finish manufacturing equipment and increasing demand for sterile products. Increasing scientific research is another important factor driving the market. Funds received from private and government organizations to support research for niche healthcare products, many people requiring healthcare and medical attention, and increasing consumption of medications are expected to influence the market growth.

SImilar to the growing trend in Biopharmaceutical drug substance production, there is now a rush for capacity to meet the demand. Being able to achieve speed to market, meeting regulatory requirements as well as scale up seamlessly and quickly, are becoming fundamental to the success of any players in this arena.