White Paper: Extractables and Leachables Testing in the Pharmaceutical Industry

Alcami has recently authored a white paper on extractables and leachables testing in the pharmaceutical industry.

Requirements from regulatory agencies have become increasingly rigorous, with regards to the detection, dentification and quantification of extractable and chable compounds in pharmaceuticals, drug delivery systems, and biomedical devices. This increased scrutiny is the result of several well-documented incidents of contaminants leaching from containers and packaging, resulting in a potential or real risk to humans.  As a result, regulatory agencies, such as the US Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA), have increased regulations on potential extractables and leachables in drug product container and closure systems. 
Topics: Extractables & Leachables White Paper / eBook

Bringing the Light to Photostability in Three Parts - Part Two

Part II: Forced Degradation Studies to Support Photostability  

In Part One of this photostability blog series, a high level review on the background of photostability was presented.  In this second part, work leading up to the execution of a photostability study on Active Pharmaceutical Ingredient (API) and pharmaceutical products will be discussed. 

Prior to execution of a photostability study, the analytical test procedures (TP) must demonstrate the ability to detect degradants caused by photolysis (photodegradation).  Not all compounds are susceptible to photolysis; a molecule must absorb the UV or visible light energy to be susceptible to this phenomenon.  For example, if the absorption spectrum of a molecule has a maximum of ~254 nm and with minimal or no absorption above 300 nm, this molecule would not be susceptible to photodegradation during an ICH photostability study as the lowest wavelength of exposure is ~320 nm. 

Topics: Stability Blogs

Alcami Announces Extended Workbench Offering for Analytical Services

Alcami, a leading provider of custom development and manufacturing services for the pharmaceutical and biotechnology industries, announces an extended, comprehensive service program that allows clients the flexibility, freedom and consistent control of outsourced laboratory needs. Our Extended Workbench is a Full-Time Equivalent (FTE) program tailored to  a client’s needs. The Extended Workbench program is effective across any pharmaceutical arena with its capacity that can vary greatly in size, management and scope.

Topics: News & Events

Editorial: Formulation Development & Manufacturing — CDMOs Offer Speed, Advanced Technologies, & the Ability to Handle More Potent APIs

Alcami recently contributed to a special feature in Drug Development and Delivery magazine titled "Formulation Development & Manufacturing — CDMOs Offer Speed, Advanced Technologies, & the Ability to Handle More Potent APIs." 

The article includes Alcami, along with other CDMOs, highlighting their capabilities in the areas of speed, quality, technology, and handling of complex APIs.

Topics: Editorials Development

Bringing the Light to Photostability in Three Parts

Part 1: Basic Requirements – Setting the Stage

ICH Guidance Q1B was published in 1996 describing a harmonized approach to photostability studies.  Although it has been 20+ years since its publishing, questions still arise on how to execute a photostability study and how to interpret the results.  In this blog series, I will address common questions and detail how a photostability study is executed.  At Alcami, photostability is conducted at three laboratory sites: Wilmington, NC; Edison, NJ; and St. Louis, MO.

A photostability study is performed using either a full spectrum light source that produces a spectrum similar to D65/ID65 emission standard, or two separate light sources: one for near UV radiation with a spectral distribution from 320 nm to 400 nm with a maximum energy emission between 350 nm and 370 nm, and a second light source that is a cool white fluorescent lamp designed to produce an output similar to that specified in ISO 10977.  Regardless of which approach is taken, the objective is to expose samples to an integrated amount of NLT 200 Watt·hrs/m2 of near-ultraviolet energy and NLT 1.2 million lux·hours of visible light. 

Topics: Stability Blogs

Elemental Impurities – Highlights of the Coming Regulation

Replacement of the wet chemistry “heavy metals” limit tests with more modern analytical methodology and conformance to new and specific limits for individual elements was a dramatic, although anticipated, change in the regulation.

The ICH recognized that prior to the Q3D Guidance, regulation of elemental impurities fell under Guideline Q3A for inorganic impurities. Existing pharmacopoeial procedures included the Heavy Metals test, Residue on Ignition/Sulfated Ash test and other wet chemistry tests. The problem with these procedures was that they were non-specific and were never intended to detect the low-level residual metal catalysts and reagents used in some modern synthetic processes. In addition, the acceptance criteria were based upon historical precedent and, although risk factors for metal contamination had changed significantly throughout the 20th century, the existing limits had not changed accordingly and had little toxological basis.

Topics: Regulatory Compliance Elemental Impurities