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Pharma Drug Development

    
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Wockhardt  From development to high-volume commercial manufacture, they utilise more than twenty-five years of contract manufacturing experience to ensure your product is professionally managed all the way to market. The employment...
 
Formulation Services Alyante – is a Wockhardt Business Initiative focused on delivering timely and quality based development services to help improve your research efficiencies...
 
Tablets With over twenty-five years of experience, Wockhardt is equipped with all the expertise necessary to supply quality solid dose formats to our clients. Our...
BioVectra Inc.   Contract Manufacturing Organization (CMO). GMP Fermentation and chemical synthesis of API's, PEGylation reagents, highly potent compounds. Reducing and oxidizing reagents for protein chemistry.
 
Contract API Manufacturing FDA Inspected Facilities
 
MPEG Maleimide Polymer for Drug Delivery
 
Baxter's BioPharma Solutions business  As a parenterals specialist, Baxter's BioPharma Solutions business offers unique delivery systems and a variety of contract manufacturing solutions to meet complex and traditional sterile manufacturing challenges.
 
cephalosporins/ penicillins Baxter's Round Lake, Illinois facility has the capabilities and controls for manufacture of cephalosporins, penicillins and non-cephalosporin in GALAXY...
 
Formulation & Development Services Helping to overcome technical challenges, including process and formulation development, technology transfer, and analytical methods development, BioPharma...
 
Capsugel  Capsugel has emerged as a global leader creating innovative dosage forms for the pharmaceutical and dietary supplements industries. Companies look to their leadership to help them formulate new products, enhance existing...
 
Manufacturing & Technical Services Capsugel is committed to providing full manufacturing support – including onsite problem resolution – for our capsule products and equipment. From...
Metrics Contract Services  Metrics Contract Services is a CDMO offering contract pharmaceutical research, pharmaceutical development, clinical trial and commercial manufacturing services. Metrics provides FTIM development and Phase I, II and III...
 
Formulations Development Metrics provides pharmaceutical product development including pre-formulation studies, formulation development, Clinical trial batch manufacturing and...
 
Potent and Cytotoxic Drug Handling Metrics’ dedicated and top-of-the-line potent facility and equipment allow us to offer greater services to clients that greatly mitigate potential for...
Capralogics Inc.  Custom polyclonal antibody services, including host cell protein, single chain llama, goat antibodies, rabbit polyclonals, sheep antibodies, llama antibodies, camelid antibodies, bulk antibodies, chicken antibodies
 
HCP Antibody Production HCP Antibodies
WuXi AppTec, Inc.  Leading outsourcing company for pharmaceutical, biologics, and medical device with operations in China and the US; Biopharmaceutical, Pharmaceutical Discovery & Development, Toxicology, Bioanalytical, GMP Manufacturing,...
 
Chiral Separation Services Systematic method development approach column/mobile phase screening technology by SFC and HPLC Preparative separations using SFC and HPLC platforms AD,...
 
Method Development and Validation Method Development and Validation Development and validation of analytical methods for APIs and formulated products. API -Potency and Impurities;...
 
Pacific BioLabs (PBL)  Pacific BioLabs is a contract research organization (CRO) offering testing and research support services to its clients in the medical device, pharm/biopharm, and other industries. Specializing in the biological sciences,...
 
Combination Product Testing Testing to support the development of pharmaceutical devices.
 
Custom Bioscience Studies Please contact BizDev@PacificBioLabs.com for more information. They will have one of our technical experts call you.
Avomeen Analytical Services  DEA Licensed, cGMP Compliant, and FDA Registered testing laboratory. Specializes in deformulation, materials identification, pharmaceutical development, cosmetics product testing, litigation support. Instrumentation...
 
Custom Synthesis Services Avomeen’s team provides inorganic and organic synthesis services for a variety of industries. With fast turnaround times and accurate results, our product...
Myriad RBM, Inc.  Myriad RBM is a CLIA-certified biomarker testing laboratory specializing in cost-effective, high-quality multiplexing services. Our protein immunoassays benefit drug discovery & development from preclinical through Phase...
 
Services Provided Myriad RBM, Inc. is the world’s leading multiplexed immunoassay testing laboratory, providing comprehensive protein biomarker services based on its...
HERMES PHARMA  HERMES PHARMA is a contract research & manufacturing organization that specializes in developing and manufacturing user-friendly solid oral dosage forms - effervescents, chewable tablets, lozenges, ODT and instant drinks.
 
HERMES PHARMA specializes in developing and manufacturing user-friendly solid oral dosage forms We offer expert advice and practical customized solutions at every point along the pharmaceutical value chain: - New product design - Formulation and...
LGM Pharma  LGM Pharma is focused on providing our clients with the latest news and updates on compounds and molecules required in the Research & Development arena. Most importantly, we are constantly updating our inventory offering...
 
Adalimumab LGM Pharma is an Adalimumab CAS# 331731-18-1 API supplier based in the USA. Inquire about DMF, cGMP, price, availability, delivery, purity, and more.
SEPS Pharma  Welcome to SEPS Pharma SEPS Pharma is a privately held pharmaceutical company with a hybrid business model engaged in drug delivery and development combining internal product development programs and drug product...
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Pharma Drug Development - Product Reviews

ABC Labs focuses on “phase-appropriate” drug-development services
Jeff Kelly, Online Industry Editor

Not all stages of the drug-development process are created equal. So scientists at Analytical Bio-Chemistry Laboratories don’t treat them the same.

“At different points in the development process, you’re looking to determine different types of information,” said Kristein King, vice president of strategy and workforce development at the Columbia, Mo.-based firm. “We help clients devise a strategy to make the most use of their money.” ... Read More


BIOCIUS focuses on speeding up drug screening
Jeff Kelly, Online Industry Editor

For BIOCIUS, speed is everything. Well, just about everything.

The Wakefield, Mass.-based firm specializes in drug screening and discovery technology and services. Its RapidFire platform can determine the chemical make-up of a given compound in a matter of seconds, according to Jennifer Rossi, director of marketing and corporate communications at BIOCIUS. That’s significantly faster than using high-pressure liquid chromatography, a more common approach to drug screening, which can take up to 10 minutes, Rossi said ... Read More


New partnerships in drug development spur trust as well as cost efficiency.

With the rise of biotech firms, the establishment of new compounds in the early drug development pipeline, and outsourcing to Pharmaceutical Drug Development services have become commonplace. Yet, these firms are emerging as trusted partners in regulatory matters internationally, experts in specific diagnostic trials, and proficient in streamlining early phase trials. And, with typical drug development from discovery to market ringing at just short of $1 billion USD and 12 years, drug development services become an attractive option to offset the costs of time and resources.

Best in Class Pharmaceutical Drug Development feature:

  • Full-scale simulations for physiological and economical modeling
  • The ability to take over development projects mid-phase and integrate data and results
  • Regulatory expertise to ensure compliance at all levels of bureaucratic and governmental oversight

Top Considerations Before Outsourcing Pharmaceutical Drug Development:

Many vendors espouse the virtues of outsourcing drug development to free up cash and resources to allocate to more core competencies for drug company clients, such as manufacturing. If this is your reason for buying, it is crucial to ensure a financial plan that sees the redeployment of internal resources to those critical areas. A modeling of the outsourced plan and budget should include a boost in productivity in a corresponding business unit due to the resources reallocation. 

Key Vendors to Consider

1. Based in Miami, Cetero’s Central Laboratory anchors their Clinical Pharmacology unit. The Clinical Laboratory is licensed in areas including Hematology, Chemistry, Coagulation, Urinalysis, Special Chemistry, Serology, and Viral Markers. Focusing heavily in allergy and asthma research, Cetero is the only professional CRO that has developed and fully validated models in the Environmental Exposure Chambers (EEC) for cGCP compliant studies. The EEC Model is a validated, rapid and FDA-accepted clinical solution for the development of small molecule drugs, immunotherapies and therapeutic devices.

2. With their Clinical Trial Simulation, Archimedes, Inc. aims to save clients valuable cash assets by modeling outcomes prior to full phase execution. Archimedes enables clients to conduct realistic clinical trial simulations to distinguish their drug’s clinical and economic benefits from standard treatments and competitor drugs. Additionally, the firm focuses on comparative effectiveness of one drug to an emerging solution, and helps clients more accurately answer questions regarding costs and target markets through healthcare modeling.

3. Specializing in antibodies, Covance prides itself on delivering solutions to client’s clinical challenges with unique solution sets, including biopharmaceutical services, clinical and nonclinical services, strategic partnering and other strategies for development. The company asserts that it generates more drug development data for the regulatory evaluation of efficacy than any other firm in the world. As so, Convance maintains a long history of successful collaborative relationships to drive down R&D costs. 

4. Symyx Isentris for SharePoint is a collection of Microsoft SharePoint Web parts that improves project team data collaboration in analysis and gives scientists access to real-time project information. Additionally, Symyx provides a host of software solutions that aid in database access, decision support, lab execution and analysis, cheminformatics and others. Symyx is dedicated to supporting their product offerings through a variety of portals for quick problem resolution. The firm will also consult on software implementation and correct solution choosing.

5. Therapure Biopharma’s Drug Development focuses on the development of therapeutic proteins – representing one-third of all new drug developments. The firm provides end-to-end trial services, process and test development, as well as final release testing, filling, packaging and shipping services. Therapure has compiled an extensive listing of proprietary products based on hemoglobin—most designed to treat infectious disease, anemia, and cancer. Protein modifica-tion technology allows clients to boost efficacy and half-life.

Pharmaceutical Drug Development
Definition: Pharmaceutical Drug Development offers "outsourced" research support to the pharmaceutical and biotechnology industries. These “outsourced” firms provide clients with research services to aid in the drug and medical device research and development process, including product development, formulation and manufacturing; clinical trial management (preclinical through phase IV); clinical, medical and safety monitoring; preclinical, toxicology, and clinical laboratory services for processing trial samples; data management, biostatistics and biomedical writing services, especially in preparation for an FDA New Drug Application or NDA. See also Clinical Research Organizations or CROs.

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Pharma Drug Development Research Library

White Paper - A New HPMC Capsule
Capsugel
A New HPMC Capsule for Optimum Formulation of Pharmaceutical Dosage Forms abstract Hypromellose (HPMC) capsules were originally formulated with a secondary gelling agent. This agent can delay dissolution in some circumstances and lead to unwanted issues during product development. In this article, we discuss the rationale for developing Capsugel’s Vcaps® Plus capsules without a gelling agent. ...
 
Myriad RBM, Inc. Document
Myriad RBM, Inc.
Myriad RBM has assembled the largest available collection of quantitative immunoassays to aid in the discovery of new biomarkers and biomarker patterns for various aspects of oncology research. See how this menu is being applied to advance researchers' understanding of cancer. Oncology is an immensely complex field that must contend with random causal events, multiple cell types, and the ...
 
Dissolution of a Phosphate Prodrug from  Hard Gelatin Capsules: A Case Study
Metrics Contract Services
Dissolution of a Phosphate Prodrug from Hard Gelatin Capsules: A Case Study Thomas B. Gold, Jennifer G. Warren, and David R. Collier OBJECTIVE To compare dissolution of a phosphate prodrug from three capsule shell types. BACKGROUND Clinical studies often include an active comparator (an active control) in the specific study design. The respective design compares the standard therapy ...
 
Preclinical Toxicology: Points to Consider in Program Design
Pacific BioLabs (PBL)
Drug development is a high-risk enterprise. The typical new drug takes 10-12 years to get to market and costs up to $500 million. Pharmaceutical companies face continually increasing challenges in drug development— shorter product life cycles, global competition, as well as daunting technical and regulatory hurdles. Meanwhile, as a result of the Human Genome Project and high throughput drug ...
 
Executing Exploratory Clinical Development Studies
SGS Life Science Services - Clinical Research
Too often insufficient predictivity of early clinical data leads to unnecessary expenses at later stages of development. Explore the benefits of considering new approaches to clinical drug development. Why consider new approaches to clinical drug development? In a standard clinical development program, the confidence level of making the best decision (go, no-go) prior to conducting a first- ...
 

Pharma Drug Development Video

Pacific BioLabs - A Bioscience Contract Research Organization Pacific BioLabs (PBL) Pacific BioLabs offers GLP/cGMP testing services to the biopharmaceutical, medical device, and combination product industries. PBL services include ...
 
Meet Metrics Contract Services Metrics Contract Services
 
Pharma Drug Development Baxter's BioPharma Solutions business Information

Pharma Drug Development News

Pharma Drug Development BioVectra Inc. Information
Pharma Drug Development Metrics Contract Services Company
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