The future of pharma manufacturing
During the last decades, batch manufacturing has been the used and trusted method for the production of pharmaceutical products. But more recently, continuous manufacturing (CM) is becoming a promising, alternative approach. At DFE Pharma, we believe that CM is the future of pharmaceutical manufacturing, and regulators - including the FDA and the EMA - agree. Continuous manufacturing is encouraged by regulatory bodies since it is in line with the quality-by-design (QbD) paradigm for pharmaceutical development. In addition, CM offers numerous advantages over batch production – not least higher product quality at lower manufacturing costs.
At DFE Pharma, we have been at the forefront of driving this change for more than a decade. We have carried out detailed research on how the excipients properties affect CM processes and partnered with leading pharmaceutical companies as they took their first steps into this new field. Our expertise has led to the development of several CM-enabled excipients, all available as part of our portfolio.
Shifting from batch to continuous production won’t happen overnight. We stand ready to support our customers and industry partners through this transformation.
Advantages of continuous manufacturing
Batch production has dominated the oral solid dose manufacturing landscape for decades. Now, the regulatory barriers to using continuous processes, like feeding, blending, granulation and tableting, are coming down.
Developers can already reap the many benefits of CM, including increased product uniformity and process optimization, fewer bio studies and shorter registration batches, and safer, fully automated, unattended production. CM also provides integrated CIP/WIP, reduces the physical footprint, waste and the scale up and production/processing times, while it increases process flexibility.
These advantages can help to reduce risks while increasing speed-to-market and product quality and significantly lowering manufacturing costs.
Our specialized portfolio: CM-enabled excipients
Although traditional processes like direct compression, roller compaction or wet granulation are used within continuous lines, the requirement for ingredients can differ from traditional batch processing. As experts in this field, at DFE Pharma we evaluated the behavior of differing grades of our excipients when applied to CM processes.
While most of DFE Pharma’s products can be used in CM processes, recent research has led to the development of our specialized portfolio of best-in-class, CM-enabled products. These excipients have been specifically designed to meet the requirements of future pharmaceutical manufacturing processes.
Your CM formulation partner
With our deep insights and ever-growing evidence base, we are more than an excipient supplier. Our CM expert team can support in the selection of robust excipients based on any formulation needs, whether Direct Compression, Wet or Dry Granulation are used. Our specialized portfolio of CM-enabled excipients, combined with our expert knowledge on how they interact with processes and ingredients (including the APIs), can help secure the success of CM projects that deliver the benefits of this new, dynamic production paradigm.
For more information on working with our dedicated CM team get in touch, or request a sample.
DFE Pharma is committed to supporting the shift to CM. Our scientific researchers have worked with universities, consortia and industry partners to deliver new insights in the benefits of CM and our CM-enabled excipients:
■ White paper: understanding and accounting for excipient variability in continuous
■ Article: Impact of excipients on batch and continuous powder blending
■ Article: Using Multivariate analysis of batch-to-batch excipient variation to reduce
risk
■ Poster: Continuous Feeding of excipients and excipient blends
■ Poster: Continuous Feeding of excipients
■ Poster: Continuous Twin Screw Granulation
■ Article: The flowability of lactose powders to optimize tableting process