Increasing Biologics Manufacturing Requires Efficient Workflows within Your Life Sciences Organization
What strategies can firms adopt to maintain efficiency when increasing biologics manufacturing? Image source: Flickr CC user IAEA Imagebank
Restructuring and streamlining operations have been a core strategy for many pharmaceutical companies in recent years. But while small molecule and solid dosage efforts are often the target of such cost-cutting measures,1 life sciences firms have been concentrating on increasing biologics manufacturing efforts.
The profits from biopharmaceutical sales justify the investment. One company experienced 20% revenue growth during the last fiscal year, further supporting their decision to construct a new manufacturing facility that more than doubles their production capacity. If projections prove accurate, the manufacturing boost will lead to an additional $40 million per year.2 But whether these biopharmaceutical expansions focus on contract partnerships or clinical-trial manufacturing, organizations cannot simply build new facilities without implementing solutions that will aid efficiency.
Market Factors Support Streamlined Workflows
A booming market, while healthy for company growth, also means increased competition. Some firms have formed collaborations with contract manufacturing organizations to deal with these pressures, but these partnerships sometimes suffer from communication issues. As more companies concentrate on increasing biologics manufacturing, firms will need to ensure their workflows are streamlined to accelerate the release cycle of high quality drugs. Some areas biologics companies need to remain vigilant about include:
- Process design: Manufacturing facilities must ensure that their processes fall within acceptable parameters. They also need to identify the ideal operating ranges which support sustainable biologics production. As pharmaceutical companies expand their biologics manufacturing arms, they need to be aware of scaling concerns to avoid quality issues. Communicating these parameters both within an organization and with contracted partners is crucial to guarantee the production of high quality products.
- Performance verification: Even though a company has a history of providing high quality products consistently, they may not necessarily be able to reproduce those results when scaling up manufacturing efforts. When firms boost drug production, they need to verify that performance remains high and monitor that processes are working as designed. Incorporating automated tools that flag deviations allow for continuous improvement, correcting variances throughout the manufacturing cycle rather than after a drug has been released.
- Regulatory compliance: The increase in biologics manufacturing efforts and in external collaborations has led to more scrutiny from regulatory agencies. Maintaining quality has grown more important than ever. Collecting manufacturing data for review has always been necessary to comply with regulatory guidelines, but it can become overwhelming as organizations grow in size. Digital systems that accelerate the gathering and analysis of this information will be a crucial step to guaranteeing manufacturing quality.
Digital Efficiency Supports Initiatives Devoted to Increasing Biologics Manufacturing
Above all, biopharmaceutical companies must ensure a quality product no matter how much they increase their biologics manufacturing arms. Doubling production capacity means nothing if they are unable to release a quality product. There are some significant repercussions of poor quality:
- Violations and citations: Increased regulatory scrutiny has led to more stringent guidelines and facility inspections. Agencies such as the FDA have demonstrated their intent to hold companies responsible for conditions and procedures in facilities even remotely connected to their biologics manufacturing efforts. Sponsor firms must ensure that partnering organizations are complying with regulatory standards, and contract manufacturers need to demonstrate that they’re operating with the most current protocols. Failure to communicate these requirements can lead to violations, and receipt of issued citations can result in fines and delayed drug launches as organizations work to address the observed violations.
- Product recalls: If deviations in manufacturing quality aren’t identified and corrected, the chances of releasing an inferior product increase. From contamination to improperly marked containers, drug recalls can result in lost millions. In the worst case scenario, patients may even be adversely affected and in a position to sue for damages.
- Damaged reputations: Pharmaceutical companies receive a lot of media attention these days. Headlines are quick to shift attention to quality missteps. In today’s highly informed society, firms cannot escape the repercussions of poor quality. Patients and medical professionals will remember and, depending on how manufacturing quality issues are addressed, negative attention may leave a lasting impression.
Manufacturing quality is often a bottleneck for many life sciences organizations. As more initiatives devoted to increasing biologics manufacturing efforts spread throughout the industry, firms will need to focus on streamlining the process to remain competitive. Beyond guaranteeing sustainable parameters are identified and followed, companies will need to confirm that they have systems in place to monitor sources of variability and signal when they fall outside acceptable limits. By doing so, companies can minimize deviations while maximizing quality.
Implementing Digital Solutions Can Encourage Productivity and Guarantee Quality
By implementing digital tools that support these goals, organizations can enable a culture that boosts productivity and quality via knowledge sharing and collaboration. Rather than coping with bottlenecks that add inefficiencies and increase the the length of release cycles, companies can streamline their workflow and scale up drug production. As more companies increase biologics manufacturing, the key to gaining and retaining market advantage will depend on maximizing efficiency.
BIOVIA offers many integrated digital solutions that support biopharmaceutical companies in their efforts to streamline workflows and reduce the release cycle, accelerating the pace of innovation. The BIOVIA Biologics Made Right First Time Industry Process Experience offers many tools that organizations can utilize to design and improve their production processes. From enabling the design of sustainable bioprocesses to validating performance standards, the solution fosters productivity and quality within an organization as well as with external partnerships. If you’re interested in learning how a digital solution can aid your efforts to expand your drug manufacturing, please contact us today.
- “Big Pharma’s Investment in Biologics,” May 3, 2013, http://www.pharmtech.com/big-pharmas-investment-biologics ↩
- “Peregrine: new biologics plant may boost contracting revenues by $40m,” March 8, 2016, http://www.biopharma-reporter.com/Upstream-Processing/Peregrine-new-biologics-plant-may-boost-contracting-revenues-by-40m ↩