Steven P. Stodghill, Ph.D.
The current field of thermal analysis is both diverse and dynamic. Although not a new field, more advanced instrumentation, techniques and applications are constantly appearing on the market and in the literature.
Anthony Severdia, Satej Bhandarkar, Daniel Fogarty, William L. Rocco
Different polymorphic forms of an API can have substantially different physical properties, e.g., solubility, stability, and ease of compaction.
Anastasia Lolas, Patricia Hughes, Ph.D, Kalavati Suvarna, Ph.D., Bo Chi, Ph.D.
Biologics are licensed under Section 351 of the Public Health Service (PHS) Act. The PHS Act requires that biological products be safe, pure, and potent, and manufactured in facilities designed to ensure the continued safety, purity and potency of such products. Under the Federal Food, Drug, and Cosmetic Act (FD&C Act) “biological products” are also drugs. A subset of biologics, specified biologics (21 CFR 601.2(a)(3) & (4)), are regulated by the Center of Drug Evaluation and Research (CDER). The Biotechnology Manufacturing Team (BMT) in the Division of Manufacturing and Product Quality in CDER’s Office of Compliance evaluates the Chemistry, Manufacturing and Controls (CMC) section of Biologics License Applications (BLAs) for monoclonal antibody and therapeutic recombinant DNA-derived products (therapeutic biological proteins) and conducts pre-license/pre-approval inspections of establishments engaged in their manufacture.
Michael N. Eakins, Ph.D.
A number of trends can be identified in the delivery of parenteral drugs in the last decade. Amongst these is the increase in popularity and sales of pre-filled syringes, a growing availability of ready-to-fill plastic pre-fillable syringes, and the outsourcing of the final preparation of primary packaging components from the pharmaceutical companies to the component vendors. Annual global sales of pre-filled syringes are currently estimated to be over 2.2 billion globally, with over 50% of the units being supplied in nests (tubs) as ready-to-fill components [1]. Here washing, siliconization and sterilization of the components is already completed (nested) as against being supplied in bulk where these steps are the responsibility of the pharmaceutical company.
Christoph Saal, Ph.D.
Within the pharmaceutical research and development field, the selection of a suitable solid-state form represents a crucial step. Selecting a solid-state form comprises several decisions, mainly the selection of a salt form and the selection of a polymorph or pseudo-polymorph of the respective salt. During the last decade, co-crystals have been added to the set of tools available for the Medicinal Chemist, Pharmaceutical Developer or Analytical Chemist.
James M. Roberts, Ph.D., Steve R. Cole, Ph.D., Helen E. Weston, William K. Young, Ph.D., Jay Spadie
Two common approaches to sample analysis exist in the pharmaceutical industry. Drug discovery organizations often employ open-access analysis, in which medicinal chemists submit their samples to automated analytical instrumentation and the analysis and reporting is performed automatically. The instrument is a shared resource used by multiple scientists. By contrast, pharmaceutical development organizations heavily favor custom analyses carried out by skilled analytical chemists using instruments dedicated to the exclusive use of a small number of analysts or projects. While NMR and LC-MS are frequently used as self-service, open-access instruments in both discovery and development, the vast majority of HPLC-UV analyses in development have not employed the open-access approach.
Nicholas Warne, Ph.D.
I recently had the privilege of chairing the 3rd Annual Lyophilization Conference held February 25-26 in Boston, MA. The conference was well organized and offered thoughtful insights for attendees who were relatively new to the field of lyophilization as well as to those who had been working in the field for decades. This article is a brief summary of the conference.
Dr. Chris Moreton, Ph.D.
To many people, the specification defines the material. However, we all know that products made with APIs and excipients properly conforming to their specifications in all respects can sometimes fail, for reasons we do not fully understand. Sometimes the cause is human; for example, there was an error in operating the process, or taking samples. Sometimes there is no explanation, and sometimes it becomes apparent on investigation that there is some property of a component that needs to be added to the specification. This component can be the API, or it can be an excipient.
Shelly Li, Ph.D.
Off-line analysis by various chromatographic techniques has traditionally been the major approach to in-process controls during the early stage of drug development. On the other hand, on-line/at-line technology such as Infrared (IR) and Raman spectroscopy has become increasingly useful tools for reaction monitoring [1-10]. The advantages of in-situ monitoring includes the capability of gaining a large amount of real time data in a non-contact manner, the analysis is nondestructive in nature, and no sampling, quenching or workup is needed that may alter the composition of the reaction mixture. A Reaction Monitoring (RM) Lab was recently established within the Research and Science Technology Division in Pfizer, where online reaction monitoring tools have been utilized for in-situ monitoring of a variety of chemical reactions in support of project progression.
Karen C. Thompson, Ph.D.
Regulatory changes have resulted in the inclusion of clinical studies with pediatric patients as an integral part of pharmaceutical product development. In the US, the FDA guidance for pediatric drug development is provided by the BPCA [1] and PREA [2]. These regulations [3] apply to any NDA, new indication, new pharmaceutical form, or new route of administration. The product specific requirements are outlined in a written request which is issued by the FDA. The EU pediatric regulations [4,5] apply under similar product filing conditions but require the submission of a pediatric investigational plan (PIP) no later than upon completion of human pharmacokinetic studies in adults.