Contract Analytical Testing Laboratory

Whether it is for routine analytical release testing or the development of challenging or specialized analytical methods for your large or small molecule,

Bedfordshire Biotech Limited’s team of highly experienced analytical chemists use up-to-date, compliant laboratory infrastructure to meet your quality standards. By integrating analytical method development and validation services with API and dosage form manufacturing, we reduce turnaround times for your drug development program and achieve key milestones faster.

Bedfordshire Biotech Limited’s comprehensive analytical services support our integrated services including drug discovery, drug development, process development, contract cGMP API synthesis, and cGMP finished dose manufacturing. Our on-site microbiology services lab is part of our complete analytical service offering.

Analytical Laboratory

Our Analytical Services area was architecturally designed to house a wide array of analytical equipment. The analytical lab supports the cGMP manufacturing services with analytical method development services, method validations, raw material release testing, in-process testing, finished product release testing as well as stability testing. Dalton utilizes current industry standard equipment including HPLC, GC, LC-MS, SEC-MALS, KF and others to support our customer requirements.

contract analytical lab services include:

Analytical Development Services
Accelerated Stability Services
Stability Storage and Testing
Flow Chemistry
SEC-MALS
ICP-MS Elemental Analysis
Microbiology Services
Chiral analysis (HPLC and GC) and preparative HPLC chiral chromatographic separations allowing detailed characterization of a diverse range of pharmaceutical, biopharmaceutical and synthetic chiral compounds
Raw Material / Finished Product Testing (including cytotoxic material)
Reference Standards Certification
Physical and Wet Chemical Analysis
Process and Cleaning Validations
Container / Packaging Testing
Thin Layer Chromatography (TLC)
Organic Volatile Impurities (OVI)
Arsenic
Melting Point
Residue on Ignition (ROI)
Loss on Drying (LOD)
Elemental Analysis (EA)
Polymorphism Screening

Some of the analytical equipment we use for large and small molecule analysis includes:

LC-MS (Liquid chromatography mass spectrometry) – LCQ Classic, LCQ Duo with Electrospray Ionizer (ESI), LCQ Deca
HPLC
- DAD – Diode Array Detector (UV)
- Variable Wavelength UV Detector
- Conductivity Detection
- Fluorescence Detection
- Evaporative Light Scattering Detection (ELSD)
SEC-MALS
GC (Gas Chromatography)
- Flame Ionization Detector (FID)
- Thermal Conductivity Detector (TCD)
- Headspace techniques (USP-OVI)
Spectroscopy UV / Visible
Infrared (FTIR)
Particle Size Analysis
Polarimetry
Osmolality
Oxygen Headspace Analyzer
Differential Scanning Calorimetry (DSC)
KF (Volumetric & Coulometric)
pH

Analytical Development Services

Bedfordshire Biotech Limited offers a full range of analytical development services to our customers.

We have extensive experience in the development of robust analytical test methods for raw materials, in-process tests, drug substances, APIs / impurities as well as drug products (including complex injectables).

Bedfordshire Biotech Limited also has experience in working with Stress Indicating Assays in support of Stress Degradation Studies.

Our experienced analytical development scientists can accelerate your development program by having the same team work on development of analytical methods for both API and finished products, thereby minimizing the overall development time.

Upon completion of the development, Bedfordshire Biotech Limited can qualify or validate the analytical test methods to your rigorous standards, including challenging the linearity, accuracy and precision of the methods, ensuring that the method performs over the desired range.

Bedfordshire Biotech Limited is your full service provider of Analytical Development Services.

Structure Elucidation of Impurities

With over 2,000 high quality research molecules in our catalogue, Bedfordshire Biotech Limited has over 30 years of expertise in structure elucidation of unknown synthetic impurities, intermediates, degradants, and excipient-related impurities.

Impurity Screening:
Identification of Unknown impurities of >0.05% abundance using internally developed or client supplied method.

Structure Elucidation Capabilities:
LC/MS/MS, FTIR, HRMS, 1D& 2D NMR, Chiral Chromatography

Isolation Techniques: Preparative HPLC, SPE, SPME, and wet chemistry procedures.

Custom Synthesis:
Our creative and highly skilled synthetic chemists can quickly turn around custom synthesis in projects to verify the final structure of the impurity.

Impurity Reference Standards:
Identified compounds can be ultra-purified for use as reference standards for QC analysis and stability impurity monitoring studies.

Timeline:
Reliable preliminary screening in 2-3 weeks or less per sample. Projects can be extended to custom synthesis, structure verification, process development, and small and medium scale production. (Expedited services available upon request).

Deliverables:

Compliant data and executed documents. CoA available upon request.

Microbiology Services

As an integrated manufacturer of API and finished dose products, including sterile injectables, we understand the critical importance of reliable microbiology testing. Bedfordshire Biotech Limited offers a full range of microbiology testing services to support every product need.

Bedfordshire Biotech Limited offers the following Microbiological Services:

Bioburden Analysis
Environmental Monitoring
Microscopic Procedures
Water Testing
Bacterial Endotoxin Testing
Bacterial Retention Validation
Particulate Matter
Sterility Testing

Microbiology Laboratory

This 350 square foot (32.5 square meter) laboratory accommodates the necessary staff and equipment to support Bedfordshire Biotech Limited’s rigorous environmental monitoring program for the GMP area. Biological safety cabinets and incubators are used for on-site bioburden testing, microbial identification and environmental monitoring of the cGMP area.

Accelerated Stability Testing

Bedfordshire Biotech Limited supports its customers’ products with our in-house stability services including full stability services from protocol development for accelerated stability, intermediate term stability and long term stability programs. Data and trending analysis performed by Bedfordshire Biotech Limited’s stability experts, means results you can rely on. We even offer stability testing programs for your controlled drug products (scheduled drugs).

Our modern laboratory and experienced analysts ensure your stability pulls are performed on time and that the high-quality test results are provided to you on schedule. We can compile and generate detailed stability reports that meet your reporting requirements for commercial products as well as programs designed to support your clinical programs.

All stability programs are maintained in qualified in-house stability chambers that are controlled and monitored 24/7 for any change in Temperature and Humidity and are fully supported with our alarm notification system and backup generator keeping your stability studies safe and secure.

Bedfordshire Biotech Limited offers a wide range of ICH compliant stability conditions including:

25°C ± 2°C / 60% RH ± 5% RH
30°C ± 2°C / 65% RH ± 5% RH
40°C ± 2°C / 75% RH ± 5% RH
5°C ± 3°C
-20°C ± 5°C
Photo-stability ICH Q1B: 14,000 Lux Vis and 200 W/m2 U

We offer a wide range of stability and analytical services:

Protocol Development
Development and Evaluation of Stability indicating methods
Long-Term Stability Testing
Intermediate Stability testing
Accelerated Stability Testing
Formulation Evaluation Stability Testing
Forced Degradation Studies
Data and trending analysis
Controlled Drug Products Stability Testing
Commercial Product Stability Testing
Comparator Stability Testing
Photostability

Let Bedfordshire Biotech Limited be your trusted partner for all of your stability and analytical testing needs.

SEC-MALS

SEC-MALS (Size Exclusion Chromatography – Multi Angle Light Scattering)

GMP/GLP Large Molecule Testing Services

With the growing number of large molecule products in development, it is more important than ever to be able to characterize your large molecule product with confidence.

That is why Bedfordshire Biotech Limited has added GMP/GLP Size Exclusion Chromatography – Multi Angle (Laser) Light Scattering (SEC-MALS) to its analytical services offering.

SEC-MALS is an established analytical method for the absolute determination of molar mass of large molecules. This approach is ideal for molecules with molar masses ranging from 10³ to 10⁹ g/mol, and is suitable for many molecule types such as:

Proteins
Peptides
Conjugates
Polymers
Biopolymers

SEC-MALS Advantages

SEC-MALS can replace a number of traditional techniques, such as viscosity, electrophoresis and retention times by HPLC, with a single absolute test.

Fast –Results in as little as one hour making it viable as an in-process test
Absolute – Molar mass is an absolute measure, not relative to a standard
Automated – Efficient and can process multiple samples quickly
Reliable – Precise and accurate molar mass results
Established – Accepted GMP/GLP test, no additional regulatory hurdles for validated methods

Bedfordshire Biotech Limited SEC-MALS Services

We Develop, Validate and Test:

GMP/GLP Compliant Services
Analytical Method Development
Method Validation
Release Testing
In-Process Testing
Stand-Alone Analytical Testing

With a rapid turnaround time and an automated process, Bedfordshire Biotech Limited’s GMP/GLP SEC-MALS services can provide you with the accurate and precise molecular mass results you need for your large molecule.

Bedfordshire Biotech Limited uses state of the art Wyatt MALS (light scattering) and Refractive Index (RI) detectors in combination with Agilent HPLCs in our GMP/GLP analytical laboratories. The automated system allows for the efficient testing of multiple samples. With rapidly available test results, SEC-MALS can be a viable option for both your in-process and product testing requirements.

ICP-MS Elemental Analysis

In accordance with the updated ICH Q3D Guideline for Elemental Impurities, Bedfordshire Biotech Limited now offers ICP-MS testing services.

Drug Products have the potential to contain contaminants or elemental residues that may be harmful to the consumer, even in small quantities. It is the responsibility of the manufacturer and distributor to ensure that any hazardous chemicals including heavy metal or elemental impurities meet the current regulatory guidelines for finished products.

With ICP-MS, we can detect:

Most elements from Li to U except C, N, O, Cl, Br, I and S
With an optimal detection range from 0.1 ppm to 1% wt & sample size as small as 0.01 g.
Parts per trillion (ppt) range for many elements in aqueous solutions

The instrument, an Agilent 7800 ICP-MS quadrupole analyzer, is currently validated and ready for use.

We Develop, Validate and Test; Dalton offers: