Using Chemical Management Software to Streamline the Transition Toward Biologic Drug Development
The chemicals needed to produce biologics are different from those required for small molecule drug synthesis. Chemical management software can help companies overcome challenges associated with changes in reagent usage. Image Credit: Flickr use Horia Varlan
Looking ahead to the future of the pharmaceutical industry, one trend is overwhelmingly clear — the growing dominance of biologics. No longer just an emerging technology, biologics made up 22% of big pharma sales in 2013, and that proportion is expected to increase to 32% by 2023.1 Meanwhile, more life sciences companies than ever are expanding their activities in this area of the industry, with over nine hundred biologics currently under development. It is estimated that the compound annual growth rate for the biologics industry will be around 10.9% from 2016 to 2024.2 As life companies transition their research and manufacturing operations toward biologics, chemical management software can help labs ensure that lab processes continue to run smoothly.
Transitioning from Small Molecule Drug to Biologics Research and Manufacturing
When life science companies begin to develop and manufacture more biologics and fewer small molecule drugs, there will necessarily be shifts in reagent usage. Chemical management software can be helpful as companies deal with inevitable changes in their expanding industry:
- Changes in the types of chemical used
Producing biologic therapeutics is fundamentally different from synthesizing small molecule-based drugs. Unlike small molecule drug production, biologics manufacturing is heavily reliant on the use of dilute aqueous solutions. Biologics manufacturing typically requires 10 to 100 times more water per kilogram of drug product than small molecule drug manufacturing, but the amount of solvent used at each step is minimal.3 As researchers test and perfect the manufacturing processes for biologics, chemical management software can monitor their usage of new reagents. That way, the lab manager can purchase the necessary quantities to keep the research going and to enable the lab to manufacture the intended amount of drug product.
- Reductions in overall chemical usage
Because small molecule drugs are produced through step-by-step chemical synthesis processes, their development and production typically requires relatively large quantities of a wide range of reagents. Labs that redirect their efforts toward biologics development may be in danger of overbuying chemicals that were previously in high demand for small molecule drug synthesis, which can lead to waste if the chemicals expire. Using chemical management software, lab managers can avoid this situation by tracking reagent use and purchasing enough to fulfill the lab’s needs without wasting valuable resources.
- Generation of safety and regulatory reports
In order to take full advantage of the biologics industry boom, life science companies need to focus on innovation. Initial discovery can be a major challenge, especially as more therapeutics than ever are being abandoned during the regulatory process due to concerns about safety and effectiveness. Plus, manufacturing processes must be carefully designed in order to ensure consistency between batches. Given these challenges, it is important for researchers to be able to dedicate their time to high quality research. Adopting software that automates tedious manual processes, such as the generation of safety and regulatory reports, can help researchers make the most of their time.
By ensuring that researchers always have the reagents they need and by automating processes whenever possible, chemical management software reduces waste and cuts down on the overall time it takes to bring a drug to market, both of which lead to costs that would otherwise be passed on to the consumer. Since one of the major barriers to growth in the biologics sector has been that these therapies are more expensive than small molecule drugs, finding ways to cut unnecessary spending can help life science companies provide biologics that are more affordable for a broader range of patients.
Supporting Multinational Expansion of Biologics Manufacturing
Another biologics industry trend to expect is a shift toward the Asia Pacific region in the coming decade.4 While North America and Europe currently make up the bulk of the industry, the compound annual growth rate of the biologics industry in the Asia Pacific region is expected to be about 15.6% from 2016 to 2024. In light of this high potential for growth, many pharmaceutical companies are expanding their biologics manufacturing operations in Asia Pacific countries.
For multinational life science companies, chemical management software can be an invaluable organizing tool. Company leaders can easily access chemical information regardless of the lab’s location, and it is possible to monitor chemical usage by location in order to compare needs and resource efficiency at different facilities. In addition, regulatory information can be configured by country in order to ensure compliance with regional standards, and safety information can be stored in multiple language, depending of the needs of lab personnel. These benefits can smooth the transition to overseas biologics manufacturing, reducing the logistical concerns that go along with global expansion.
Overall, whether transitioning a lab toward biologics development or establishing manufacturing facilities abroad, modern software can help life science companies improve operational efficiency. BIOVIA CISPro is an advanced software solution that supports effective chemical management. Contact us today to learn more about this and our other software offerings that can help your company make the most of upcoming changes in the pharmaceutical industry.
- “Going Large,” December 30, 2014, http://www.economist.com/news/business/21637387-wave-new-medicines-known-biologics-will-be-good-drugmakers-may-not-be-so-good ↩
- “Asia Pacific Biologics Market Analysis for Cell Therapy & Gene Therapy by 2024,” December 22, 2016, http://www.digitaljournal.com/pr/3184031 ↩
- “Environmental Considerations in Biologics Manufacturing,” April 12, 2010, http://pubs.rsc.org/en/content/articlelanding/2010/gc/b927443j#!divAbstract ↩
- “Asia Pacific Biologics Market Analysis for Cell Therapy & Gene Therapy by 2024,” December 22, 2016, http://www.digitaljournal.com/pr/318403 ↩