Featured Bioprocessing Editorial

  1. FDA’s New Population Pharmacokinetics Guidance — What Drug/Biologic/Device Makers Need To Know

    The draft guidance calls for sponsors of new drug and biologics license applications to apply population PK analysis, which is frequently used to guide drug development and inform recommendations on therapeutic individualization. It also includes common applications of population PK analysis, the FDA’s current thinking on the data and model requirements needed to support regulatory decisions, recommendations to sponsors on drug labeling based on population PK analysis, and general expectations.

  2. Analyzing FDA’s Draft Guidance On Premarket Review Of Combination Products

    The new EU draft guidance, Guideline on the quality requirements for drug-device combinations, and U.S. draft guidance, Principles of Premarket Pathways for Combination Products, are the latest attempts by each body to adequately regulate combination products. In this two-part series, we examine the two guidances in detail. Part 1 covers the U.S. regulatory guidance.

  3. FDA Takes Aim At Regenerative Medicine Compliance With New Rapid Inquiry Program

    Regenerative medicine holds a lot of promise for patients, while many current therapies being used have an underwhelming amount of evidence to back claims being made. A June 2019 FDA announcement for a time-limited program, the Tissue Reference Group (TRG) Rapid Inquiry Program (TRIP), focuses attention once again on the FDA’s comprehensive regenerative medicine policy framework. Through Dec. 31, 2019, the TRIP aims to provide a three-day turnaround on responses to manufacturers who wish to obtain a “gut check” on the regulatory pathway of their product.

  4. Recovery Studies: Common Issues & Using Statistical Tools To Understand The Data

    This article is the first in a series of articles that will explore some of the typical issues that may be encountered during recovery studies and show how the use of statistical tools for assessing the recovery data can provide greater insight into the results and enable data-driven decisions concerning recovery studies. In this installment, we will look at three case studies.

  5. FDA’s Top 5 Drug GMP Inspection Citations In FY2018 — With FDA Analysis

    In Part 1 of this two-part article, FDA supervisory consumer safety officer Dell Moller, Office of Pharmaceutical Quality Operations (OPQO) Division 3 program director Art Czabaniuk, and OPQO Division 3 investigator Lindsey Schwierjohann presented #10 through #6 of the top drug GMP inspection citations for FY2018 and provide insight into the observations. This part counts down citations #5 through #1.

  6. Think A Quality Culture Doesn’t Affect Your Bottom Line? Think Again

    Maintaining quality is everyone’s job and a team effort. And when it is overlooked, bad things happen. News of a pharmaceutical company receiving an FDA Complete Response Letter and Form 483 — citing data manipulation and breaches — drove this point home recently. Based on the FDA observations made in this case, there is clear evidence that components of a voluntary quality assurance (VQA) culture were missing.

  7. Does Blockchain Make Sense For The Cell & Gene Therapy Supply Chain?

    Understanding the impact and requirements for a clearly defined supply chain strategy and implementing this into the complex environment of cell and gene therapies is not a simple task. It requires dedication and participation from all the stakeholders across the development-to-delivery life cycle. All the details need to be defined, simulation models developed, and risk assessed — and remediation plans put in place. 

  8. 5 Barriers To Blockchain Adoption In The Rx Supply Chain — And How To Overcome Them

    Blockchain has already started to find fit-for-purpose use cases in the pharmaceutical industry. Some of the largest pharma companies in the world are now conducting pilots and are expected to move towards production cases in the coming year. But for blockchain to succeed, several remaining obstacles must still be overcome.

  9. 7 Speed Bumps To Avoid When Outsourcing Clinical Supply Manufacturing

    Any company with successful Phase 1 study data must ensure sufficient and consistent supply of drug product for possible Phase 2 and Phase 3 trials. For this reason, Phase 1 companies planning to outsource manufacturing of their clinical supply should take some essential steps early in the clinical manufacturing campaign to assure a timely and reliable supply of material throughout their clinical trials.

  10. What Celgene Corp. v. Peter Means For Biosimilar Developers

    A recent decision by the U.S. Court of Appeals for the Federal Circuit has indicated that pharmaceutical makers with patent protection are unlikely to receive any compensation from the government for the loss of their patents during inter partes review (IPR) decisions by the Patent Trial and Appeal Board (PTAB).