We kick off the last issue of the year with the experts at BioPlan Associates, who have followed the bioprocessing industry for 30 years and have taken note and reported on advances and critical issues in this field through their annual study, which provides insights from over 220 global bioprocessing professionals. In “BioPharma Over 20 Years,” BioPlan’s K. John Morrow and Eric Langer point out just a few of the significant trends, changes and developments affecting the industry over the past decades as they affect contract manufacturing and outsourcing. These include: changes and new developments in manufacturing efficiency and productivity; the rapid expansion of outsourcing as a viable option for the industry; the proliferation of new companies and bioprocessing technologies; and the upward trend of FDA approvals for new biopharmaceutical products.

Recent developments impacting the Chinese fine and specialty chemical industry have far reaching implications in the West, according to the authors of this next article. This reflects the increasing dependence on China for the supply of several products—be they intermediates or end molecules ready-to-be formulated. In “Towards Sunset or a New Dawn?” Michele Jermini (Alfa Chemicals Suisse SA) and Enrico Polastro (Arthur D. Little) say China is in the middle of a transformation as the country is rapidly transitioning towards a new stage of its development where quality of life and environmental considerations are increasingly superseding the quest for GDP growth at all costs.

Next on tap, Grand River Aseptic Manufacturing (GRAM), a fast-growing contract development and manufacturing organization (CDMO) based in Grand Rapids, MI, offers its expertise on what it takes to build effective pharma partnerships. Beginning here, Judy Meyers, senior business development manager at GRAM, highlights the keys to forming and maintaining successful relationships. Tune in as she shares her viewpoints on how to earn—and keep—your spot atop corporations’ short lists of CDMOs.

Our next article adresses a timely and controversial topic: vaccines. Today’s vaccine developers are currently under pressure as the uptake of vaccines falls in most middle and high-income countries as a result of negative comments in press articles or misinformed social media exchanges. In this article, Adrian Wildfire, scientific director at SGS Life Sciences says this downplaying of the benefits and exaggeration of adverse events associated with vaccination programs has coalesced into an “anti-vax movement” and he makes the case for why the general public needs to be better informed.

Shifting to supply chain trends, serialization data resulting from global regulatory requirements has created the ideal opportunity to establish end-to-end value networks that generates transformative value from this data across all segments of the pharmaceutical supply chain. In “The Future of the Pharmaceutical Supply Chain,” John Hogan, senior vice president of engineering at TraceLink, discusses how serialization has opened the door for digitally enabled visibility, how other market shifts are heightening the demand for a more streamlined, integrated, and responsive end-to-end supply chain and how a network platform can enable this demand.

Lastly, regenerative medicine is one of modern science’s most exciting developments. However, according to Rich Quelch, global head of marketing at Origin, accomplishing the goal of widespread use of regenerative medicine doesn’t come without its challenges. In this article he says offering regenerative medicine therapies at scale requires one of the biggest shake-ups to the global pharmaceutical supply chain ever seen. Without it, the world risks missing out on the curative promises of this next-generation medical technology.

These are just some of this issue’s editorial highlights. There is, of course, much more! If you have any ideas for article topics, or are interested in authoring a piece, feel free to contact me anytime!

Tim Wright, Editor
twright@rodmanmedia.com