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318 McCullough Ave. , San Antonio, TX, 78215, US
A look at in vitro release testing for semi-solid topical dosage forms and recent changes in testing standards.
Released By DPT
QbD is a systematic approach to pharmaceutical drug manufacturing development. QbD is built on a deeper understanding of the causes and effects of variability in the manufacturing process. This understanding is based on sound science and risk management. Without QbD, quality must be “inspected in” to a product at the end of the manufacturing cycle. […]
Is your development or manufacturing operation experiencing cost over-runs and unproductive delays? Do you want to optimize your development dollars and ensure a robust commercial process? You are not alone. The conventional development process uses an empirical approach that requires continuous end product testing and inspection to determine quality. The processes that create the end […]
This paper describes the approach and benefits of using DPT Labs’ QbD Scale Up service and follows the third paper in our Thought Leadership Series, “QbD Based Process Development Services – The DPT Labs Approach.” In that paper, we emphasized the importance of DPT’s approach to process development, in particular the rigorous analysis of both […]
This paper describes the approach and benefits of using DPT Labs’ QbD Process Development service and follows the second paper in our Thought Leadership Series, “QbD Based Formulation Services – The DPT Approach.” In that paper, we emphasized the importance of DPT’s approach to formulation, in particular the manner in which it establishes a robust […]
This paper describes the approach and benefits of using DPT Labs’ QbD Formulation service and follows the previous paper in our Thought Leadership Series, “What is QbD and Why Should You Care?” DPT Labs’ QbD Formulation service leads a customer through a rigorous process that minimizes risks to development success. Beginning with a Quality Target […]
With the increased globalization and complexity of the pharmaceutical supply chain, managing the sourcing of materials has become extremely challenging. Reducing time and costs are important goals of sourcing, but increased regulations and more rigorous enforcement make these goals difficult to achieve. These trends have forced life science industry companies to optimize sourcing activities for […]
SAN ANTONIO, TEXAS, Oct. 16, 2013 – Pharmaceutical contract development and manufacturing organizations (CDMOs) DPT Laboratories , based in San Antonio, Texas, and Confab , based in Saint-Hubert, Quebec, today announced the integration of the organizations under the leadership of P aul Johnson, Group President and COO. Both DPT and Confab are owned by Renaissance […]
This document explains how and why a contract development and manufacturing organization (CDMO) can help your business thrive under changing market conditions. It also provides tips for initiating, building and maintaining a service provider relationship that benefits both parties. THIS IS AN EBOOK!
The role of sterility is a simple one–it is to protect people against infection and contamination, which is a particular issue when sterile products are used in seriously ill people whose immune systems are already compromised. Because of the risk of infection, sterility is particularly important for injectables and eye products, and the primary challenge […]
The objective of the research was to assess the feasibility of delivery of Iron-Dextran via transdermal route with the aid of microneedles to treat Iron Deficiency Anemia in hairless rat model. Technology used in the research has the potential to replace injectables and, in doing so, increase patient compliance.
This study shows how high-resolution measurements of human usage (“ergonometrics”) of a commercially available nasal spray pump device vary between different age groups of people, including the effect of dominant vs. non-dominant hand, and how these ergonometrics are related to in vitro performance. The QbD approach used in the study was designed to fit with […]
R&D experts explain why particle size analysis is of paramount importance in pharmaceutical product development and why light scattering and optical microscopy methods are typically employed for particle size analysis in drug development and quality control activities.
Controlled substances are highly regulated and must be vigilantly monitored from the laboratory to the marketplace to prevent theft and illicit sale in the black market, a growing trend. In 2011 there were 36 cases of pharmaceutical cargo theft in the United States at an average value of more than $500,000 per incident. Abundant federal […]
SAN ANTONIO, TX – DPT Laboratories, a contract development and manufacturing organization (CDMO), announced today that it ha s added two new members to its sales team. Timothy J. O’Neill has been named Busine ss Development Manager for DPT’s Midwest Sales Territory, where he will manage and implement the sales process for the company’s drug […]
SAN ANTONIO – DPT Laboratories, a contract development and manufacturing organization (CDMO), announced today that Kuljit S. Bhatia, Ph.D., has been named Vice President of Research & Development. Bhatia, who has more than 15 years of pharmaceutical experience in drug product development, previously was Vice President of Research & Development and Technical Operations at Fougera […]
With more than $30 million in recent enhancements complete, DPT’s Center of Excellence for Sterile and Specialty Products provides our customers comprehensive pharmaceutical development and manufacturing services for drug products with sterile requirements. Aseptic Manufacturing Services Aseptic processing and filling suites for small volume parenterals, ophthalmic preparations, nasal sprays and ointments Pilot, clinical trial material […]
In our dedicated cGMP manufacturing facility, we provide innovative solutions to the unique challenges of manufacturing aerosol formulations. Manufacturing Capabilities for Aerosol Formulations cGMP compounding batch sizes from 0.3 kg to 25,000 kg cGMP filling from pilot to clinical to commercial scale Controlled substances Schedule III – V Extensive range of canister and bottle sizes […]
In response to growing market needs for a flexible solution provider with small and clinical scale capabilities, DPT now offers comprehensive development, manufacturing and testing services for pMDIs. Manufacturing Capabilities for pMDIs: Clinical trial materials Batch sizes from 1 liter Dymel® (HFA 134a), Pharma 227, blended and other propellant options Single and dual phase filling […]
For more than 30 years, DPT has supported customers’ sourcing strategies by providing technology and site transfers. DPT can help whether your organization is rationalizing its pharmaceutical manufacturing operations, you’re making a transition from your CRO for later-stage clinical trial materials, or you’re looking for a highly specialized capability. Site and Technology Transfer Services Formulation […]
DPT’s Center of Excellence for Semi-solids and Liquids includes three cGMP pharmaceutical manufacturing facilities supported by in-house quality and microbiology labs, robust quality systems and a team of highly skilled technicians and customer service representatives to support your manufacturing needs. Semi-solid and Liquid Pharmaceutical Manufacturing Services Pilot, clinical trial material and commercial-scale manufacturing cGMP batch […]
In addition to DPT’s comprehensive pharmaceutical development capabilities, we provide specialized testing services for nasal sprays and pressurized metered-dose inhalers (pMDI). Specialized testing services for nasal sprays and pressurized metered-dose inhalers include: Device robustness Spray pattern Plume geometry Spray content uniformity Droplet size (laser diffraction) Tail-off characteristics Priming and repriming Repriming/effect of resting time Effect […]
DPT combines an extensive understanding of the regulatory approval process with an exemplary regulatory history to fully support our customers’ pharmaceutical development programs. Our customers benefit from in-house preparation of Modules 2 and 3 (CMC) drafts of the Common Technical Document (CTD) as part of their pharmaceutical development projects. Key Customer Benefits CMC preparatory services […]
DPT scientists develop scalable formulations that help our customers expedite their pharmaceutical development programs from benchtop to clinical trial materials to market. Our formulation scientists and manufacturing teams can work directly with you or your CRO to assist with technology transfers for later phase clinical trial materials, registration batches and commercial launch. Clinical Trial Materials […]
Each DPT Center of Excellence is supported by a full-service, in-house microbiology laboratory. Microbiology testing and services performed by these labs include: Microbial Limits Assay Development, Testing and Validation Microbial limit testing Test method validation/suitability Bioburden test validation/determination Bacterial and fungal identification Antimicrobial Effectiveness Testing Minimum inhibitory concentration Bacterial Endotoxin Testing Gel clot method Validation-inhibition […]
DPT’s development teams have extensive expertise designing and conducting stability studies for pre-market and commercial pharmaceutical products, including products containing controlled substances. At our Centers of Excellence in San Antonio, Texas, and Lakewood, New Jersey, we offer stability studies under ICH conditions or custom conditions that your product may require. Stability Services Informal, formal, accelerated […]
DPT begins each development project with the commercial manufacturing process in mind. Our formulation scientists work closely with our manufacturing groups to develop formulations that are scalable from pilot batches to clinical trial materials to commercial supplies. DPT has the expertise to optimize your pharmaceutical manufacturing process whether your product is a new formulation, you […]
Whether you’re developing a new pharmaceutical product or improving an existing drug delivery system, DPT’s pharmaceutical packaging services help you identify and source the best drug packaging for your product. Pharmaceutical Packaging Services Identification and sourcing of relevant packaging options Design input to initial concepts Packaging specification development Formulation and package compatibility assessment Proof-of-concept demonstration […]
DPT provides comprehensive analytical development and analytical validation services to support drug development projects as well as commercial drug manufacturing. Analytical method development and assessment for small molecules, peptides and proteins Stability-indicating assays Diffusion studies (Franz cell) Gas and liquid chromatography, including UPLC, GC/MS and LC/MS/MS UV-Vis and IR spectroscopy Wet chemistry In-vitro release studies […]
Raw material sourcing Solubility profile (in buffers and non-aqueous solvents) and partition coefficient of API API compatibility with excipients Stability of API and factors affecting stability (including heat, light and pH) Method development and method transfer for particle size of wet and dry particles by laser diffraction (for both API and the formulation) API characterization […]
“Validation of a Particle Size Determination Method for Nano-particles by Dynamic Laser Light Scattering”. R&D experts explain why particle size analysis is of paramount importance in pharmaceutical product development and why light scattering and optical microscopy methods are typically employed for particle size analysis in pharmaceutical product development and quality control activities.
“Comparing Size Distribution of Particles Using Spraytec™ and Mastersizer™” DPT’s R&D experts provide findings in their study to determine if Malvern Spraytec™ could be used to measure both droplet size distribution of aerosols emitted from sprays and measure particle size distribution of wet or dry products.
The International Conference on Harmonization (ICH) Common Technical Document (CTD) format is the submission standard for new and abbreviated drug product applications in the United States, the European Union and Japan. One of the significant sections of the CTD is the Pharmaceutical Development Report (PDR). A complete PDR is essential to provide a comprehensive understanding […]
Collaborative partnering between Contract Development and Manufacturing Organizations (CDMO) and the drug product submission applicants (Applicant) is becoming increasingly important with the emphasis on product design by regulatory agencies. The CDMO can provide the appropriate resources to build the scientific knowledge base for the product and the depth of science-based information for the drug design […]
Contract Development and Manufacturing Organization (CDMO) that understands customer needs, regulatory requirements and has a proven track record for developing and validating analytical methods can minimize developmental costs and reduce the time to market. Properly validated drug product characterization methods are necessary for regulatory filings, but can also reduce overall turnaround time during scale-up, clinical […]
Drug delivery via the inhalation route is an efficient, safe and efficacious method for local and systemic administration of certain therapeutic agents.This white paper provides insight into the aspects of formulation development, packaging development and analytical development associated with inhaled drug delivery as it relates to pressurized metered dose inhalers (pMDI).
Industry reports identify a growing competitive landscape internationally, which has created a greater demand for outsourced services; but how does one find a contract development and manufacturing organization (CDMO) with the appropriate capabilities, expertise, readiness and proven ability to transition from concept to commercialization? This white paper provides key elements to consider when selecting a […]
There are many factors to take into consideration when selecting or designing a packaging component. Steps involved during the initial stage of the process are extremely important in ensuring that the most optimal packaging is identified. Working with a contract development and manufacturing organization (CDMO) early in the process helps eliminate packaging problems that may […]
Because the efficacy of the drug product depends on the ability of the spray device to deliver reproducible plumes and uniform dose content, some aspects of nasal spray development are unique such as formulation, container closure system, plume characterization, manufacturing and stability testing. Therefore, these aspects need to be carefully considered during the development program.
With the FDA’s heightened focus on safety, regulatory agencies are increasing their presence in the manufacturing arena to ensure Current Good Manufacturing Practices cGMP are top of mind, and sponsors are placing greater responsibility for meeting cGMP requirements onto their outsourcing partners.
Controlled substances are highly regulated and must be vigilantly monitored from the laboratory to the marketplace to prevent theft and illicit sale in the black market, a growing trend. In addition to abundant federal and state regulations, increased globalization – with its stringent import and export restrictions, permits and declarations required for controlled substances – […]
A Contract Development and Manufacturing Organization DPT is a contract development and manufacturing organization (CDMO) providing companies the best solutions to their sterile and non-sterile pharmaceutical development and manufacturing needs through innovation, technology and service. Specializing in semi-solid and liquid dosage forms, DPT has a reputation for quality, unmatched technical expertise, extensive manufacturing capabilities and […]
“Enhancing the Solubility of Poorly Water-Soluble Drugs in the Presence of Nano-Emulsion Particles” – DPT’s R&D experts explain the effects of different types of nano-emulsions and the particle size of the nano-emulsion on the solubility of different APIs.
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