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Eric Langer

Creating Effective Leachables and Extractables Testing: Whose Responsibility Is It?

The problem of leachables and extractables (L&E) in single-use devices continues to hound both suppliers and end-users, and remains one of the more challenging issues inhibiting regulatory acceptance of single-use devices.

by: Eric Langer
Published: April 20, 2015
Tags: leachables, extractables, leachables and extractables testing, single-use devices, Eric Langer, 12th Annual Report and Survey of Biopharmaceutical Manufacturing, biomanufacturing


Eric Langer

A Fully Disposable Bioprocessing Facility: Is it on the horizon?

Single-use, disposable bioprocessing reached the Billion-Dollar club this year, and judging by suppliers’ sales growth, it continues to gain broad industry acceptance. The many advantages offered to CMOs and biotherapeutic developers have been well documented.

by: Eric Langer
Published: February 12, 2015
Tags: single-use, disposable bioprocessing


Eric Langer

Single-use Disposables are Future Proofing Biopharmaceutical Manufacturing

Biopharmaceutical companies that get stuck with legacy technologies, including older stainless steel equipment, and older processes, end up watching as competitors transition to more efficient, cost-effective platforms. In this column Eric Langer breaks down the trends in the biomanufacturing industry and shows that the addition of single use systems is adding flexibility.

by: Eric Langer
Published: October 23, 2014
Tags: biomanufacturing, single use systems, disposable solutions, pharma manufacturing, Eric Langer


Eric Langer

Biopharma Suppliers’ Budgets Increase: Bellwether for Better Times

Biopharmaceutical companies have weathered a rough recession, layoffs, and budget trimmings. These cutbacks have affected their vendors as well. In BioPlan Associates’ 8th Annual Report and Survey of Biopharmaceutical Manufacturing, we surveyed 352 biotherapeutic manufacturers, and 180 of their vendors, in 32 countries. The substantial budget cuts at vendors that started in 2008 have begun to turn around. We measured 10 budget areas for vendors to this industry. Sales budgets, the only area that did not take a downturn, continued to increase, this year, by an average of 5% globally.

by: Eric Langer
Published: December 15, 2011
Tags: Eric Langer, manufacturing, surve, biopharmaceutical, BioPlan Associates, R&D


Eric Langer

Single Use Device Adoption Impacted by Slow Standards Setting

Leachables and extractables category, (which also leads the 2011 list of Factors Restricting Use of Disposables) are a key concern. Worries over “leachables and extractables” have increased for both groups over the past 4 years.

by: Eric Langer
Published: October 10, 2011
Tags: Eric Langer, BioPlan Associates, leachables, extractables, disposables, CMOs, single use systems, disposables, disposable biomanufacturing, biomanufacturing, disposable solutions


Eric Langer

Higher Tech Outsourcing Repositions CMOs

While many biomanufacturers continue to view outsourcing as part of their cost reduction approach, more are considering how they can incorporate outsourcing of the technical more complex upstream and downstream operations as part of their business strategy. If biopharma companies hold to these plans, the outsourcing arena may change considerably over the next few years.

by: Eric Langer
Published: September 7, 2011
Tags: Eric Langer, biomanufacturing, outsourcing, CMOs, CMO, contract manufacturing, biopharmaceutical manufacturing, BioPlan Associates


Eric Langer

Single Use Bioreactors Lead in New Use and Market Penetration

Single use technologies are strong change agents in biopharma manufacturing. Disposable devices emerge once again as a top new technology of interest among the 352 surveyed biomanufacturers in BioPlan Associates, Inc.’s 2011 8th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.

by: Eric Langer
Published: August 8, 2011
Tags: Eric Langer, single use bioreactors, biopharma manufacturing, disposable devices, single-use systems, biopharmaceutical manufacturing, bioreactor adoption, BioPlan Associates, production bioreactors, disposable bioreactor systems


Eric Langer

BioPharma Budget Bump—2011 Sees Spending Upswing

Budgets for the biomanufacturing sector of biotech show a significant upswing from recent years’ freezes and cuts. In fact, respondents to BioPlan’s 8th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production projected only increases in 2011. This budget bump reverses the previous 2 years’ slashes. While a single year does not define ongoing trends, responses register a positive change from recession-reduced allocations in all areas.

by: Eric Langer
Published: June 8, 2011
Tags: Eric Langer, BioPlan Associates, Inc