Services

Qualified Person (QP) Release Services

Cubi-Tech employs a range of Qualified persons (QP), who are experienced industry veterans, trained in a wide range of technical knowledge pharmaceutical formulation, manufacturing and development. Cubi-tech aims to manufacture the products under contract manufacturing and investigational medicinal products (IMP) after successful MHRA inspection. Each QP, who shall be named on the site license takes personal responsibility for the quality of our client’s materials. Our qualified persons will:

• Provide clients with easy to follow release procedures, implementing consistent, intelligently designed, streamlined guidelines which have been the subject to repeated reviews.
• Providing consultancy on good manufacturing practices (GMP), proactively ensuring continued, up-to-date compliance.
• Auditing of all third party manufacturing, supplying, packaging, testing and labelling facilities, ensuring compliance with QP declarations and responsibilities.
• Providing advice on project validation can be supported as required.

Quality Assurance and Quality Control (QA/QC) testing

We know how essential it is for our clients to ensure product quality and performance consistency of all materials, so at Cubi-Tech we make sure to offer a diverse range of techniques allowing us to provide exhaustive QA/QC testing of all pharmaceutical products.

Our experts will work closely with the clients to develop quality assurance programs, to ensure batch uniformity and performance tailored to your criteria.

Cubi-Tech have comprehensive quality assurance programmes to ensure that every step of the process of requesting, sampling, analysing and reporting – is monitored to ensure the correct tests are performed, that reliable results are produced and communicated with our clients in a cost-effective and timely manner.

Microbiological Testing

Microbiological testing services are a pivotal requirement for a number of industries where processes or products are at risk of becoming contaminated by the presence of bacteria, pathogens, moulds and other micro-organisms. Ensuring the safe consumption of pharmaceuticals is a number one priority at all stages of pharmaceutical production, so Cubi-Tech is proud to offer comprehensive microbiology testing services operated by our world class team of experienced experts. Our aim is to provide reliable, rapid and microbiological results to not only help your product meet statutory safety requirements, but also protect the health of consumers. Cubi-Tech labs have a range of test methods available and comply with specific retailer standards.

Pathogens Testing

Our microbiological testing is able to identify a huge number of common Bacteria, Viruses, Parasites, protozoa, Fungi and the toxins they produce, Including:

• Salmonella
• Listeria
• E.coli
• Campylobacter
• Shigella
• Vibrio
• Cl. perfringens
• Coliforms
• Enterobacteriaceae
• Pseudomonas aeruginosa
• Staphylococcus aureus
• Yeast & Moulds

In addition to identifying pathogens on food and pharmaceuticals, we will also be able to offer Total viable count, to give you a quantitative estimate of the concentration of microorganisms within your samples.

As well as routine microbiological analysis of foods and drugs, Cubi-Tech offers microbiological support options including:

• Shelf life evaluations: Using either standard storage conditions, such as refrigerated, frozen or ambient, Cubi-Tech labs are equipped to accurately determine and provide guidelines on the shelf life of your product to best protect against pathogens. In addition to this we also offer bespoke trials, tailored to your needs, to mimic consumer use. For example, this can include package opening or storage temperature change.
• Environmental monitoring: Utilizing swab samples, contact plates or settle plates, cubi-tech is equipped to evaluate the relationship between your sample and its surrounding environment.
• Hand Swabbing: To evaluate the likelihood of infection during handling.

Process Development & Validation

At Cubi-Tech We use our experience, expertise in combination with our world-class facilities to effectively bring your APIs and small molecule intermediates from early phase clinical development to large scale, commercial production.

Our Capabilities

Our pharmaceutical process development services combine creative solutions to early phase challenges with a thorough knowledge of the rigours of validation. As a result, we can help you to avoid late stage process changes, which could impact your time to launch. The result is more efficient preparation of your APIs and intermediates and greater confidence in your project’s success. These process development services include:

• Analytical method development: At Cubi-Tech, have the ability to optimize methods using a wide range of analytical techniques such as DSC, XRPD, Particle size analysis, NMR and many more allowing us to analyse how to best process your sample. We follow detailed Standard operating procedures and stringent quality assurance practices to comply with cGMP standards
• ICH stability studies: Cubi-tech can provide a number of stability testing and storage services in accordance with ICH and WHO guidelines for a variety of APIs, pharmaceuticals, biopharmaceuticals, organics, medical devices and more. Using this information we are able to tailor your drugs to meet your shelf life needs.
• Literature/database/patent searches: Cubi-Tech employees an experienced team of scientists from industrial and research backgrounds. As such we are able to complete full literature checks of existing pharmaceutical forms, to ensure we produce a unique designs for our clients
• Process manufacture development: Cubi-tech offers a complete GMP Twin-Screw Extrusion line and well-equipped tablet development Lab as well as a number of in-line monitoring tools to generate data on your product manufacture real time. Our team of renown experts are able to Quality by Design (QbD) principals we are able to design the most efficient and cost-effective methods to produce your products and with the help of in-line process monitoring, can identify and optimize the critical-process parameters to ensure we are developing the best methodology for our clients.
• Pharmaceutical Release services: Cubi-Tech offers the capacity and a breadth of capabilities to test your drug product, intermediary or in-process materials in a timely manner. Testing against specification for identity, potency, impurities, physical properties and safety under strict GMP compliance, we are able to validate your materials are being released as intended.
• Process Validation: Cubi-Tech provides a complete validation package according to regulatory and GMP guidelines. With us, you’ll have everything you need to ensure the reliability of your supply with consistently high quality. These include:
  • Process validation with critical parameters
  • Validation of analytical assays
  • Impurity Testing
  • Full material physiochemical characterization
  • Stability Studies
  • Product release testing

Drug Product Development

Cubi-Tech operates State-of-the-Art, custom designed GMP facilities to develop your clinical products into a range of desired solid dosage forms, tailored to your needs. This allows Cubi-Tech to address the increasing demand to bring clinical candidates thorough the drug development pipeline faster, while maintaining quality.
The following details Cubi-Techs range of manufacturing techniques to bring your clinical candidates to completed drug product realization:

• Twin Screw Extrusion: Cubi-Tech is equipped with a GMP grade Pharma 11 Twin-screw Extruder, which can be utilized to produce a number of dosage forms. The twin screw extruder contains Co-Rotating twin screws, placed inside a temperature controlled barrel, where material is fed in and processed under tightly controlled conditions. Our extruder is able to process over 1kg worth of materials per hour In batch sizes up to 20kg. Our GMP facilities are able to perform screening work, manufacture prototypes and produce clinical batches, with a range of materials. We are able to work with OEB class 4 materials. Cubi-Tech is proud to offer:
  • High Shear Granulation (Dry and wet granulation capabilities)
  • Multi-Component drug production (cocrystals, Salts, Hydrates ect.)
  • Cream Production
  • Polymer Filament Manufacture
  • Film extrusion
  • Solid Dispersion manufacture
  • Drug Coating
  • Pellatization
  • Taste Masking
• Tableting: Cubi-Tech operates a well equipped GMP tableting lab, fully equipped with an automatic tablet press. Utilizing this we are able to process up to 15,000 tablets per hour in batch sizes of up to 50kg. We can achieve this through direct compression techniques or through combination with our materials, we can Pharma 11 Twin screw extruder in cases where prior granulation is needed. Cubi-tech has the capabilities to work with OEB class 5 materials, meaning no matter the potency of your handle it.
• Co-milling/Cutter Milling: Cubi-Tech has the capacity to process and manufacture a number of specialized products which require particle size reduction. Our specialized machinery can perform dry milling or take a liquid or slurry and break down particles and increase dispersion. Our technicians have experience working in particle size reduction, formulation development, agglomeration and filtration working with different materials of various viscosity’s.
• V-Blending: Cubi-Tech operates a modern, GMP V-blending lab to assist any business which requires fast blend times, while maintain the highest standards of product consistency, uniformity and homogeneity, whilst also preventing unwanted product aggregation. Our V blender operates at a batch capacity of anywhere between 1.5-25L and our trained staff know how exactly to optimise it for peak performance.

Elemental Impurities (EI)Testing

Elemental impurities are trace amounts of metals that can be found in finished products and can originate from several sources during the drug development process, most often arising during interactions with processing machinery, from catalysts or from containment vessals. As these can effect drug efficacy and in some cases be directly toxic for patients.
Cubi-Tech offers GMP certified elemental impurity analysis services, in accordance with USP <232> and ICH Q3D guidelines to our customers. These recent requirements demand stringent EI testing, to determine any metallic impurities in an API during product manufacture. To meet these demands Cubi-Tech offers:

• Define the required impurities to test for
• Define the required limits to test for
• Determine at what stage during processing, your material comes into contact with impurities
• To guide you through the challenges from EP, USP and ICH Q3D, and manage these challenges on our clients behalf accordingly
• Prepare a fully validated, tailored approach for EI testing, based on your specification

Our elemental impurity experts are experienced across a range of modern techniques provide method development, validation and routine testing in a reliable, rapid and cost-effective manner.

Impurity Isolation, Identification & Characterization

A key step in solving the many hurdles encountered during pharmaceutical development is the ability to Isolate and Structurally characterizing small amounts of material. Afterall, the more you know about impurities in your sample, the better you can optimize its development to remove them.

Impurity Isolation: Impurity isolation is often required at different stages during the drug development process, to identify and characterize them so it can be understood from where they are occurring and how to remove them. Cubi-Tech has a number of techniques developed for impurity isolation, with multiple modes of separation including normal and reverse phase High Performance Liquid Chromatography (HPLC), to enable isolation of materials as necessary.

Impurity Identification and Characterization: Cubi-Tech has a vast verity of analysis equipment to understand all there is to know about impurities in your materials. Areas of expertise and capabilities include XRPD, NMR, DSC and SEM. The most difficult structure elucidation challenges require an integrated approach that utilizes advanced analytical techniques in concert. Cubi-Tech excels at tackling such problems efficiently and providing concise professional reports suitable for inclusion in regulatory filings.

Technology Transfer

Cubi-Tech know technology transfers are important step in the drug manufacturing process and as such wish to carry out this stage efficiently and effectively to give our clients a significant strategic and financial advantage. Even when the transfer is urgent, we can execute it quickly and effectively to get your project back on track and preserve the supply of product.

In all cases, we are able to work to your deadlines, are flexible in our approach are able to provide you with our full and consistent support through every stage of the process. Dependent on your batch size, cubi-tech are able to offer significant scale-up services as well, and are happy to work through this in detail with our customers.

Cubi-Tech experts are experienced in Technology transfer processes and are provided with ongoing training and support to provide you with a detailed, smooth and problem free Tech-Transfer plan.