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Understanding Biopharma Raw Materials Trends

 

By Gearoid O'Rourke, VP Global Marketing at Aceto

 

 

Biopharma manufacturing is complicated and nonlinear. It includes a wide range of processes that may affect drug efficacy and safety. The raw materials used in the processes can become principal sources of variation in process outcome and end-product quality.

Biopharmaceutical manufacturers employ source components that include diverse materials, including cell media, excipients, and chemicals for modification and purification processes. A lack of consistency in raw materials can significantly impact the efficacy, safety, and stability of the drug product.

 

Global events such as the pandemic compound these challenges by impacting the availability of quality raw materials. COVID-19 placed extraordinary strain on biopharma supply chains worldwide, shining a spotlight on system fragilities. This has led to a reevaluation of current sourcing strategies, with a focus on the security of supply and the elasticity of distribution networks.

 

 

The Growing Demand for Biologic Medicines

Pre-COVID-19, researchers estimated an annual market growth of 10+% for biologics. The pandemic accelerated the uptake of biopharma drugs, radically changing the landscape. While the global biopharma market had an estimated value of more than $274 billion in 2020, the market is expected to exceed $703 billion by 2027.

 

Material demands have increased as the demand for vaccines and other COVID-related biologic drugs has spiked. In addition, the aging population continues to grow sparking demand for drugs to treat chronic health conditions.

 

Based on a census report, the global population of people aged 65 and older is expected to nearly double between 2025 and 2050, reaching 1.6 billion. Meanwhile, the overall population is projected to increase by only about 34 percent during the same 25-year period.

 

 

Meeting the Changing Demand for Excipients and Raw Materials

Through predictive analytics and continued observation of the global market, Aceto had already anticipated biopharma's increasing need for high-quality GMP raw materials and critical excipients before the pandemic and had developed a growth strategy to meet demand.

 

As a part of that strategic plan, we expanded our manufacturing capabilities through the acquisition of six additional companies in the past year, including A&C, A&C Bio Buffer, Cascade Chemistry, Finar, Islechem, and Syntor Fine Chemicals. The acquisitions enhanced our existing sourcing & distribution model with unique research and development (R&D) and GMP manufacturing expertise.

 

Our new product categories through acquisitions include critical raw materials for both upstream and downstream processing, as well as excipients and buffer solutions.

 

 

Choosing Quality Raw Materials that Comply with Regulations

Raw materials used in biopharma must comply with stringent quality and regulatory standards. Aceto’s recent acquisition of A&C and Finar – which are both ISO and EXCiPACT certified (respectively an internationally recognized quality management standard and an international certification scheme) - shows Aceto’s commitment to the highest quality, purity, safety and suitability standards. Over 140 of our biopharma products are provided with a full Product Information Package, and we offer a range of custom GMP services to meet the unique needs and requirements of our customers.

To ensure exceptional quality for our distributed products, we audit each of our supply partners – only approving a partnership after our global quality team has completed a thorough audit.

 

 

Transporting Raw Materials

In addition to recognizing the need for quality raw materials, we also understand the need for timely shipments, including during periods of supply chain disruption. Currently, Aceto oversees more than 5,000 international chemical shipments annually and boasts a market leading on-time in full (OTIF) rate. The know-how necessary to transport highly regulated products internationally is indispensable in the biopharma industry.

 

 

Overcoming Supply Chain Challenges

Aceto continues to keep a finger on the pulse of the changing global supply landscape. Noting the challenges that have been highlighted during the pandemic and that have affected the biopharmaceutical industry, Gearoid O’Rourke, Aceto’s Vice-President of Global Marketing, offers an informed prediction:

 

Material suppliers will face more scrutiny from the finished drug manufacturers. They will need a deeper understanding of manufacturing partners and sites, regulatory reputation, and material quality. For this reason Aceto has chosen to have full control over the supply chain, from manufacturing to customer delivery.

 

Understanding that subpar raw materials and late transport can have dire effects on production quality and output, risk mitigation and timely delivery remain paramount at Aceto. Accordingly, even amid a challenging supply chain environment, we maintain a solid sales, inventory, and operations (SIOP) process that prioritizes the needs of our customers.

 

For our distributed products, our procurement teams are strategically positioned in high-impact regions, such as Asia and Europe, where they remain in constant communication with Aceto sales personnel—offering real-time feedback to notify customers of possible delays. With rapid, consistent input, our clients can adjust their purchasing plans as needed.

 

To supply the needs of customers, raw material suppliers must become more diverse in their manufacturing efforts and invest in logistical improvements. Suppliers who rise to the challenge will have a positive global impact, helping bring life-changing biologics to patients regardless of where they live in the world.

 

 

Aceto provides a wide range of standard and tailored GMP excipients and raw materials to suit your needs and solve your specific challenges.

Contact us to discuss your raw materials requirements for your biopharma formulations. 

 

If you are interested in learning more on this topic from Aceto's team of experts, join our upcoming live webinar on "Current and Future Trends in Biopharmaceutical Raw Material Selection" (register here)