Biologics Feature Introduction
Biologics are no longer seen as the ‘next big thing’ in drug development; they are now a mainstay in many pipelines. Although they cost considerably more than small molecule therapies, as long as biologics do a better job of treating the chronic diseases that typically afflict an aging population, they will remain a cost-effective option.
The 2017 Nice Insight Contract Development and Manufacturing Survey has highlighted some of the key trends in the outsourcing of biologics manufacturing, based on input from over 700 industry professionals representing all sizes of pharmaceutical and biotech companies from around the developed world.1
Of those respondents actively engaged in the development of biologics, 51% are active in new biological entities and 33% in biosimilars. The types of biologics in their pipelines were highly varied: 51% mentioned vaccines, 46% blood factors, 44% included hormones and growth factors, and 42% cited antibody-drug conjugates (ADCs) and monoclonal antibodies (mAbs), with 41% naming interleukin-based products and 37% recognizing interferon and TNF factors.1
While slightly fewer were likely to outsource new biological entities (NBEs) at 21% and biosimilars at 17% than they were their small molecule equivalents and over-the-counter medicines (at a combined 41%), there has been a substantial amount of outsourcing both for drug substance and drug product. Of those who outsource drug substance services for large molecule APIs, 44% mentioned R&D, 56% clinical-scale manufacturing and 35% commercial-scale manufacturing.1
Large numbers of those who outsourced biomanufacturing services specified microbial cell line–based development and biomanufacturing (48%), vaccine development and manufacturing (46%), mammalian cell line–based development and biomanufacturing (43%), cell and gene therapy services (37%) and advanced antibody-based products (23%).1
Biotechnology-related events rank highly among those respondents that plan to attend trade shows this year; 37% of those surveyed still use these shows as a means of finding suppliers. Between 27% and 30% of respondents plan to go to BIO International, BIO Europe and BioProcess International (BPI), making them three of the four highest-scoring shows, and well ahead of CPhI Worldwide (22%).1
One of the key advantages of biologics, and particularly mAbs, is how they address the trend towards personalized medicine and patient-centric drug development. Cell and gene therapies are also highly regarded, with a huge pipeline in spite of relatively few commercial products. The rise of biologics has also led to an increasing number of clinical trials, and the path towards innovative ways of conducting them.
Meanwhile, equipment is developing rapidly and biopharmaceutical manufacturers are adopting multiple technologies to move away from fixed-scale batch processing to more flexible, automated modular and flow-optimized processes. This is widely seen as the most important challenge in manufacturing terms for the industry.
Because of their greater viscosity, biologics have traditionally been formulated for parenteral delivery. Ingenious new devices to facilitate injectable delivery continue to be launched, but oral, inhalation and transdermal methods of delivery will also be needed to enhance compliance and improve the patient experience.
Patients will increasingly be informed participants in this process, and their involvement will play a major role in determining what biologics get used in future treatments. That is certainly a challenge that must be addressed and perhaps the biggest ‘new thing’ of all.
- 2017 Nice Insight Contract Development and Manufacturing Survey.