As novel types of Biologics have been developed, changes in biomanufacturing approaches have been running in parallel with the intention of maximising yield and lowering production costs. Evolution Global have identified 8 key production trends that will shape the Future of BioManufacturing, the third of which is Reductions in Market Scale Quantities.
INTRODUCTION
Many novel treatments are being targeted towards orphan indications and/or conditions which offer a personalised medicine approach, resulting in a reduction in the manufacturing scale required. Evolution Global’s analysis focuses on regional scale as it pertains to types of treatment that are currently in development in active, industry-funded clinical trials across the world.
REGIONAL FOCUS: THE RISE OF THE EAST
We are amid a paradigm shift in regional centricity as it pertains to biopharmaceutical clinical development. Historically North America (USA & Canada) followed by Europe have been the powerhouse regions of Biopharmaceutical Development and Manufacture. As an increasing number of Phase 1/2 developments enter from China, the APAC region will soon overtake Europe in terms of initial developments that will translate to later stage developments and eventually products. With regards to active industry-funded biopharmaceutical clinical trials as of the end of June 2017, the current global situation can be summarised as follows:
Of note is the fact that active early-stage trials (Phase 1/2) in China/South Korea/Taiwan are now comparable to ongoing developments in Europe. The compound annualised growth rate (CAGR) in early-stage trials highlights the rise over the last 10 years:
TREATMENT FOCUS: THE RISE OF CELL THERAPY
Running in parallel with the regional shift are changes in the categories of biologics themselves. It is likely that novel Monoclonal Antibodies, Vaccines and Peptides will continue to hold a predominant position. Assuming comparable clinical trial attrition rates, there will be a rise in Cell Therapy approaches for both Cancer and Regenerative Medicine.
Of the note is the potential rise in autologous-based cell therapies, which may account for approximately 10% of total Biopharmaceutical production within the next 7 to 10 years.
SCALES BY THERAPEUTIC CATEGORY
From a manufacturing point of view, it is likely that market scale options will expand to include greater utilisation of Single-Use Disposables at the 2L volume which, if optimised, can offer a 5-fold reduction in volume with same output when compared to stainless steel vessels. For Allogeneic Regenerative Medicines, Cancer Immunotherapies and Gene Therapies, disposable 2L scale is likely to be the primary format utilised going forward. The choice of DSP mode (Downstream Processing) is likely to have a significant influence, with viable options such as Batch, semi-continuous and continuous requiring consideration. Scales for Autologous Regenerative Medicines and Cancer Immunotherapies would be much smaller.
| Category | % of Total in 7 to 10 years | Manufacturing Options |
|---|---|---|
| Allogeneic Cancer Immunotherapy | 3% to 13% | Disposable 2L Scale; Options: Continuous, Semi-Continuous |
| Allogeneic Regenerative Medicine | 5% to 7% | Disposable 2L Scale; Options: Continuous, Semi-Continuous |
| Autologous Cancer Immunotherapy | 5% - 8% | Disposable < 500ml; Continuous |
| Autologous Regenerative Medicine | 2% - 4% | Disposable < 500ml; Continuous |
| Biobetter Peptides/Proteins (Incl. Fusion) | 2% - 5%% | Stainless Steel > 10L, Batch to Batch, Continuous or Disposable 2L Scale; Options: Continuous, Semi-Continuous |
| Biosimilar Antibody | 6%-8% | Stainless Steel > 10L, Batch to Batch, Continuous or Disposable 2L; Scale Options: Continuous, Semi-Continuous |
| Biosimilar Peptides/Proteins (Incl. Fusion) | 2% - 5% | Stainless Steel > 10L, Batch to Batch, Continuous or Disposable 2L Scale; Options: Continuous, Semi-Continuous |
| Gene Therapy | 2% - 4% | Disposable 2L Scale; Options: Continuous, Semi-Continuous |
| Improved Plasma IG | 2% - 5% | Traditional |
| Novel Peptides/Proteins (Incl. Fusion) | 8% - 11% | Stainless Steel > 10L; DSP Options: Batch, Continuous or Disposable 2L Scale; Options: Continuous, Semi-Continuous |
| Novel Monoclonal Antibodies (Incl. ADC & Bispecific) | 20% to 24% | Stainless Steel > 10L, Batch to Batch, Continuous or Disposable 2L Scale; Options: Continuous, Semi-Continuous |
| Vaccine (Infectious Disease) | 7% - 14% | Traditional; or if Viral based, Disposable 2L Scale; DSP Options: Continuous, Semi-Continuous |
CONCLUSION
Going forward, there is no doubt that biopharmaceutical manufacturing scales will change to smaller scales that offer outputs similar to larger volume stainless steel vessels. Additionally the sector will experience a regional paradigm shift, with China replacing Europe as the second most important geographic region for manufacture overall.
Please use the buttons below to navigate through Evolution Global’s “Future of BioManufacturing” series. The next key trend examines the impact of Perfusion Culture.