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BAL is CGMP Compliant!

BAL is CGMP Compliant!

CGMPBAL is excited to announce that we are now fully CGMP-compliant to current pharmaceutical requirements. The first question you may be asking yourself is what does CGMP compliant mean? It means that our pharmaceutical clients can rely upon Brooks Applied Labs for our technical acumen and quality as well as the documentation and system demands of the Code of Federal Regulations (21 CFR Parts 210, 211, and 11) and International Council on Harmonization (ICH Q7, Q9), especially as related to our compliance with data integrity requirements. This also means that our clients no longer need different laboratories to support CGMP, R&D, and MS&T facets of their business cycles, which equates to increased efficiencies and standardized high data quality throughout their enterprise. Browse our updated Pharmaceuticals Website for additional information. You can also quickly and easily request a quotation through our website!

Welcome Chuck Bagi!

Welcome Chuck Bagi!

Chuck BagiWe are thrilled to announce that Chuck Bagi has joined Brooks Applied Labs as a Technical Sales Specialist. As a key member of our Business Development team, Chuck is responsible for identifying and capturing new opportunities to collaborate with our pharmaceutical market clients as well as supporting our clients working on Department of Energy sites. He works closely with our business development and project management teams to ensure that the client’s objectives are met and the best possible analytical solution is selected for each project. Chuck is originally from Michigan where he received his BS degree in chemistry from Oakland University in Rochester. In his free time, Chuck enjoys playing guitar and riding motorcycles. Welcome to the Brooks Applied Labs family, Chuck!

Elemental Quality Perspectives for Chemically-Defined Media

Elemental Quality Perspectives for Chemically-Defined Media

BioPharma SolutionsWhen an out-of-specification (OOS) event is encountered, investigative teams often direct their initial focus on physical attributes of the production cycle. Sifting through temperature logs, calibration data, and personnel training records can only get you so far when pursuing a root cause analysis. An often-overlooked fact is that biologically-derived pharmaceutical drugs rely upon controlled chemical environments for both production and drug viability.  Minute differences in both micronutrients and contaminants play a key role in mitigating OOS events, as well as optimizing yield and maintaining drug efficacy. To protect their investments and maximize profitability, pharmaceutical companies must incorporate chemistry quality testing beyond what their supply chain can typically support. Brooks Applied Labs has been supporting the pharmaceutical industry for over a decade in not only understanding complex chemical systems but also providing analytical services at highly specialized levels.

Micronutrients and contaminants play antagonistic roles for all organisms, which is why it is imperative to monitor for small changes in concentrations in each lot of chemically-defined media. Chemically-defined media contains a plethora of components, from salts to amino acids and transition metals, and each chemical must be monitored for both the target concentration of metal and metalloid micronutrients but also non-target (contaminants) elements which can be cytotoxic.

The first step to integrating chemistry into quality systems is requiring that each lot for every component applied to chemically-defined media has a subsample that is retained for future investigative analyses. The next stage is to ascertain if the appropriate acid-cleaned container was used for storage (also offered by BAL). By working with in-house scientists, as well as the experts at BAL, a list of elements can be generated that includes both micronutrients and possible contaminants. Understanding that the concentration of elements in the final chemically-defined media is cumulative and impacted by each component, analytical data objectives must be defined. Validated methods must then be referenced to ensure compliance. Finally, a rigorous testing regimen needs to be defined and adhered to.

Of course, the aforementioned approach to the modification of a quality system is simplistic and the actual implementation will require significant resources. However, the outcome will be a more robust quality system with an increased confidence in profitability for current and future lines of drugs. If you are currently in a state of duress over an OOS event or are compelled to mitigate future ones, contact us today. In the world of pharmaceutical drug manufacturing, time is money, and our job at BAL is to advance your interests as fast as possible.

USP 232/233 Analysis for Compliance to ICH Q3D

USP 232/233 Analysis for Compliance to ICH Q3D

In order to standardize the approach for compliance analyses to support the ICH Q3D Guideline for Elemental Impurities, the U.S. Pharmacopeia (USP) generated the guidance methods USP 232 and 233. The ICH guideline applies to new finished drug products (as defined in ICH Q6A and Q6B) along with new drug products containing existing drug substances. Brooks Applied Labs is a CRO specializing in elemental and metalloid speciation analyses, period. Our focus makes your decision regarding partnering on ICH Q3D compliance an easy one.

The guideline, not the associated USP monograph, stipulates exactly how to address spectral interferences associated with mass spectrometric measurements. Elements in the mid-range mass region (30 amu -114 amu) are more prone to positive biases than heavier elements using mass spectrometry.  Brooks Applied Labs uses some of the most advanced analytical technologies, inductively coupled plasma triple quadrupole mass spectrometry (ICP-QQQ-MS), to deliver results of unparalleled quality. Research at Brooks Applied Labs has identified that operating ICP-MS instruments in KED mode, which most other laboratories are limited to, cannot properly remove all relevant spectral interferences. In addition, by using acid cleaned labware integrated into a robust quality system, biases are documented and mitigated on a continual basis reducing your risk when selecting a CRO.

Brooks Applied Labs has been audited by our pharmaceutical clients, third party accreditation services, as well as the FDA, which play an invaluable role in our desire to continue to improve our quality systems and support our clients’ needs.

The elements included in the ICH Q3D guideline are placed in three classes based on their toxicity and likelihood of occurrence in the drug product. The table below delineates the classifications:

Classification Elemental Impurities
Class 1 As, Cd, Hg, and Pb
Class 2A Co, Ni, and V
Class 2B Ag, Au, Ir, Os, Pd, Pt, Rh, Ru, Se, and Tl
Class 3 Ba, Cr, Cu, Li, Mo, Sb, and Sn
Other Elements
Al, B, Ca, Fe, K, Mg, Mn, Na, W, and Zn

 

The ICH Q3D guideline should be consulted with regards to performing a risk assessment for the listed elemental impurities. Tables presenting the permitted daily exposures and extrapolated permitted concentrations are listed in the tables below. The tables are for reference purposes only and reflect the ICH Q3D Guideline as of January 1, 2019.

Permitted Daily Exposures for Elemental Impurities1

Element Class Oral PDE (μg/day) Parenteral PDE (μg/day) Inhalation PDE (μg/day)
Cd 1 5 2 2
Pb 1 5 5 5
As 1 15 15 2
Hg 1 30 3 1
Co 2A 50 5 3
V 2A 100 10 1
Ni 2A 200 20 5
Tl 2B 8 8 8
Au 2B 100 100 1
Pd 2B 100 10 1
Ir 2B 100 10 1
Os 2B 100 10 1
Rh 2B 100 10 1
Ru 2B 100 10 1
Se 2B 150 80 130
Ag 2B 150 10 7
Pt 2B 100 10 1
Ll 3 550 250 25
Sb 3 1200 90 20
Ba 3 1400 700 300
Mo 3 3000 1500 10
Cu 3 3000 300 30
Sn 3 6000 600 60
Cr 3 11000 1100 3

1Values in this table have beeb taken from Table A.2.1 from ICH Q3D. Please see the respective ICH guidelines for additional information.

Permitted Concentrations of Elemental Impurities2

Element Class Oral PDE (μg/day) Parenteral PDE (μg/day) Inhalation PDE (μg/day)
Cd 1 0.5 0.2 0.2
Pb 1 0.5 0.5 0.5
As 1 1.5 1.5 0.2
Hg 1 3 0.3 0.1
Co 2A 5 0.5 0.3
V 2A 10 1 0.1
Ni 2A 20 2 0.5
Tl 2B 0.8 0.8 0.8
Au 2B 10 10 0.1
Pd 2B 10 1 0.1
Ir 2B 10 1 0.1
Os 2B 10 1 0.1
Rh 2B 10 1 0.1
Ru 2B 10 1 0.1
Se 2B 15 8 13
Ag 2B 15 1 0.7
Pt 2B 10 1 0.1
Ll 3 55 25 2.5
Sb 3 120 9 2
Ba 3 140 70 30
Mo 3 300 150 1
Cu 3 300 30 3
Sn 3 600 60 6
Cr 3 1100 110 0.3

2Values in this table have been taken from Table A.2.2 from ICH Q3D. Please see the respective ICH guideline for additional information.

Brooks Applied Labs has been audited by our pharmaceutical clients, third party accreditation services, as well as the FDA, which play an invaluable role in our desire to continue to improve our quality systems and support our clients’ needs. Our approach to quality is dynamic with the understanding that the regulatory environment can, and will, change necessitating a proactive approach by both our clients and Brooks Applied Labs.

Contact us to find out how your quality and process objectives can be met more efficiently than ever.

BAL is On the Road Again…

EWCPS - Pau, France 2019BAL’s methods are predominantly based on ICP-MS technology so it should surprise no one that the Winter Conference on Plasma Spectrochemistry is one of the highlights of our year. This year’s conference takes place February 3-8 in Pau, France, and Dr. Nausheen Sadiq will be presenting exciting new research on iodine isotopic ratio analysis in kelp samples. BAL’s Dr. Hakan Gürleyük and CEO Michelle Briscoe will also be attending this year’s conference. Please contact us if you will be attending and you’d like to connect, or if you would like more information about this new method!

Battelle’s Conference on Remediation and Management of Contaminated Sediments will be held February 11-14 in New Orleans and BAL’s  Dr. Stephen Springer and Jamie Fox will be attending. Stephen will be presenting a poster on an exciting new method that he developed for the determination of elemental mercury in soils. Please contact us if you will be attending or if you would like more information about this new method!

ACCBIOBAL’s Business Development Director, Russ Gerads, will be attending the International Conference on Accelerating Biopharmaceutical Development in Carlsbad, CA from February 17-20. Schedule a meeting with Russ to learn more about our novel technologies for not just advancing biopharmaceutical development but achieving greater yield and reducing risk in your current operations through chemistry.

A Busy Month for BAL’s Road Warriors

BAL’s Technical Sales Manager, Jamie Fox, is headed to Las Vegas to attend the 2018 Department of Energy Analytical Services Program (DOE ASP) Workshop. This annual training workshop will be held from August 29-30 and covers the validity, reliability, and defensibility of environmental data services. Please contact us if you would like to learn more or connect with Jamie while he is in the area.

Business Development Director, Russ Gerads, will be on his way to Boston to attend the BioProcess International Conference & Exhibition. During this 3-day event, September 5-7, Russ will be networking, learning, and sharing his knowledge on how trace metals can impact biopharmaceutical manufacturing. If you would like to arrange a time to visit with Russ or learn more about this topic, please contact us.

Canadian Mineral AnalystsFrom September 9-13, Ben Wozniak, BAL’s Technical Services Specialist, is headed north to Trail, BC to attend the Canadian Mineral Analysts (CMA) Conference and Exhibition. While there, Ben will be presenting on the topic of “Critical Considerations for Ensuring Data Quality”. Be sure to let us know if you would like to connect!