Avid Bioservices is your CMO partner offering a suite of fully integrated, comprehensive biomanufacturing services that support the development and cGMP production of clinical and commercial-stage monoclonal antibodies, recombinant proteins, and enzymes. Our client’s success is our main focus. With over 15 years of experience, Avid provides services that support every phase of development: cell line optimization, process development, analytical methods development, clinical and commercial cGMP manufacturing, and regulatory support.
As the wholly owned subsidiary of Peregrine Pharmaceuticals, a clinical-stage biotechnology company, Avid manufactures products for Peregrine’s ongoing clinical trials as well as for clients. Our first-hand experience with Peregrine’s clinical products — combined with an accomplished management team in the field of development and commercialization of therapeutic proteins — provides clients with a unique insight into managing the process development, scale-up, and validation ch...
Bosch Packaging Technology has been supplying the pharmaceutical industry with final fill solutions for over 30 years. During that time, Bosch has continued to focus on quality and industry-leading customer-focused solutions that provide the best return on investment over time.
Filling Systems
Bosch is the premier supplier of final fill–finish solutions to the pharmaceutical industry. As a single-source supplier with the industry’s widest portfolio of solutions, Bosch can supply the type and scale of equipment you require. We offer systems for bulk syringes, vials, ampules, cartridges, and prefilled syringes from laboratory scale to high-speed production. Our project management team will work with you as your system is pretested in our facility to ensure that it performs as promised before delivery.
Sterilization Systems
With the acquisition of SBM, Bosch now offers a full line of sterilizations systems. Specially made for the rigors of the pharmaceutical industry, Bosch sterilizers are designed for maxim...
Expertise
Cobra Biologics is a rapidly expanding international contract manufacturing organization (CMO) of biologics and pharmaceuticals for clinical and commercial supply. Cobra has three good manufacturing practice (GMP) approved facilities, each with expertise tailored to serving our customers across the world. We offer a broad range of integrated and stand-alone contract services, stretching from cell line and process development through to fill and finish for the supply of investigational medicinal products and commercial production.
Experience
For over 15 years, we have taken pride in being a trusted manufacturing provider, delivering what we promise and helping our customers to develop medicines for the benefit of patients. Cobra provides manufacturing technologies, platforms, and solutions to the pharmaceutical industry covering antibodies, recombinant proteins, viruses, phage, DNA, whole cell vaccines, and therapeutics as well as biologics and small molecule API lyophilization and fill–finish.
O...
The commercial prefilled syringe line at Cook Pharmica can process up to 600 syringes per minute, 36,000 syringes per hour, or 70 million syringes per year. The automated, high-speed syringe line is fully enclosed in a barrier isolator to provide the highest level of aseptic processing available by removing the human element from the entire process. With the ability to operate in smaller batches or full-scale campaigning, the prefilled syringe line is capable of bridging clinical programs into commercial production.
The process starts in a separate tub-loading room where tubs are loaded onto a pass-through conveyor and sent into the isolator for automatic debagging. After the tub is removed from the bag, it passes through a tunnel utilizing E-beam technology for tub decontamination. When it exits the E-beam tunnel, robotic arms remove the lid and liner to prepare the syringes for denesting and filling.
The line is capable of time-pressure or peristaltic filling, with temperature-compensating recirculation...
Mesenchymal stem cells (MSCs) are an attractive target for clinical study as therapeutic agents. However, current multilayer flatbed culture-expansion paradigms are cumbersome, time consuming, and typically limited in the ability to monitor cell characteristics during the growth process.
We have used the Mobius
®
CellReady 3-L bioreactor in combination with microcarriers and human mesenchymal stem cells (hMSC) as a model. Following expansion, we have comprehensively compared the characteristics of cells grown in the bioreactor with those grown in standard two-dimensional (2D) cultures. It has been demonstrated that MSCs grown on microcarriers in a stirred-tank bioreactor showed the same phenotypic and genetic markers as cells grown in standard 2D cultures:
Millipore’s Mobius
®
CellReady 3-L bioreactor is a single-use, stirred-tank bioreactor ideal for cell culture process development. Arriving preassembled and gamma irradiated, the CellReady 3-L bioreactor significantly reduces the assembly time, downti...
Georgia’s strong and growing fill and finish sector includes access to an extremely talented workforce and world-class global infrastructure for cold chain, logistics and transportation.
World-Class Distribution and Logistics Infrastructure
Cold-Chain Storage in Georgia
Hartsfield–Jackson Atlanta International Airport
Talented Workforce
Georgia’s public colleges and universities awarded more than 4,700 bachelor of science degrees in biotechnology and health-related programs in fiscal year 2012.
The University of Georgia’s regulatory affairs graduate-education programs prepare regulatory affairs professionals for careers in the medical device, pharmaceutical, biologics, and animal health business. The program covers
Biomedical engineering graduate students at the Georgia Institute of Technology can earn an online graduate certificate from the University of Georgia’s Regulatory Affairs (RA) Fast Track Initiative.
Ranked number one in the United States for workforce training and part of the Technical College...
Kemwell Biopharma is a single-source service provider supporting early product development to commercial supplies of biopharmaceutical products.
Founded in 1980, Kemwell is a 100% customer-oriented company with expertise in contract development and manufacturing services for pharmaceutical and biopharmaceutical products. Throughout its journey, Kemwell has maintained its pure-play status as a 100% contract services provider. Their core values and work culture being: “Customer Comes First.
Always.
” Kemwell has been successfully serving Big Pharma customers, including AstraZeneca, Bayer, GSK, Merck, Novartis, Pfizer, and many small and mid-pharma companies from its FDA and EMA certified facilities in India and Sweden.
Kemwell now extends its reach to allow the biotechnology industry to take better advantage of the eastern promise of cost savings combined with the support and technology of the west. To offer these services, Kemwell has built a new 135,000- ft
2
biopharmaceutical development and manufactur...
NNE Pharmaplan has developed a new facility concept called Bio on demand™, which enable facilities to be established in one to two years. The result is a flexible facility that is fully operational and locally compliant, with functioning quality systems. Bio on demand™ involves a high degree of single-use technology to ensure cost-effective production and fast establishment.
Facilities based on our Bio on demand™ concept can be delivered globally, but they are primarily intended for growth markets where time to market is particularly essential.
Full Package for Full Predictability
Bio on demand™ includes engineering and supply of a facility as well as related quality systems, standard operating procedures and coordination of necessary quality tests.
When executing a project, NNE Pharmaplan’s overall objective is that the customer develops new capabilities and grows existing ones. And by not only providing a facility, but also a full turn-key solution, we allow our customers to focus on creative aspects ra...
Technology transfer (TT), the transfer of technical know-how from a product sponsor company to a contract development and manufacturing organization (CDMO), is the cornerstone of a fruitful working relationship between the parties. It is critical for successful advancement of the sponsor’s product development and commercialization efforts. Having worked with more than 100 clients over 14 years, PCT has performed nearly as many TT programs, underscored by the key success factors listed below.
Communication:
Upon establishing a collaborative sponsor– CDMO staff “team,” it is crucial to identify which communication and project management models work best for the relationship, to agree on frequency and nature of communication, and to establish the most effective communication resources, information exchange platforms, and progress/decision tracking mechanisms.
Clear Expectations:
A program charter should be developed to clearly define the overall goals, deliverables, success/acceptance criteria, timelines, ...
CRM197 is a nontoxic mutant of diphtheria toxin containing a single amino-acid substitution of glutamic acid for glycine. CRM197 is a well-characterized carrier protein used in a number of approved and highly successful conjugate vaccines including Pfizer’s Prevnar
®
pneumococcal vaccine, a multibillion-dollar franchise; HibTiter
®
(
Haemophilus influenzae
b) vaccine, and Novartis’ Menveo
®
meningococcal vaccine.
Traditionally, CRM197 is produced by fermentation of a
Corynebacterium diphtheriae
C7 (β197) tox (–) strain, which secretes it into the culture supernatant. It is then recovered after separation of biomass and purified using filtration and chromatographic steps. Typically, titers and overall yields are relatively low.
Pseudomonas fluorescens
is a useful host for high-level production of recombinant proteins. Pfenex Inc. has developed a BSL-1
P. fluorescens
production strain that produces high levels of CRM197, along with corresponding purification methods. Both cGMP and preclinical grade...
Identifying the most appropriate contract manufacturer that is most likely the best match for your lead pharmaceutical candidate is a true challenge. Rentschler is a biopharmaceutical manufacturer with over 35 years proven track record. Focused on mammalian cell lines, our experience covers the development, production, and aseptic filling of recombinant proteins such as cytokines, enzymes, monoclonal antibodies, and fusion proteins in compliance with international GMP standards (EMA/FDA). We don’t just claim to be reliable and experienced; our many successful projects and long-lasting client relationships show that we are.
Innovative Technology
Rentschler’s proprietary TurboScreen platform enables the simultaneous production of up to 20 early stage drug-candidate variants in stable CHO cell lines. With this technology, the selection of the most suitable drug candidate is very fast and easy. In a standard 16-day fed-batch cultivation process, a sufficient amount of material can be supplied within just six ...
Sandoz is one of the leading specialists in biotech development and manufacturing. Comprehensive know-how is based on more than two decades in microbial and mammalian cell culture production at commercial scale. Today Sandoz offers a broad variety of integrated services including innovative expression systems, process development, scale-up, and production of recombinant products derived from microbial systems and mammalian cell culture in state-of-the-art facilities.
Our expertise is based on numerous projects successfully performed in collaboration with our customers. Currently, Sandoz is manufacturing more than 25 different recombinant products for well-known pharmaceutical and biotechnology companies located in USA, Europe, and Japan. Our FDA approved facilities fulfill worldwide quality requirements.
Services Offered
Production of Recombinant Peptides and Proteins:
150-L, 1,300-L, 3,000-L, 13,000- L, and 40,000-L fermentors are available in our facility in Kundl, Austria. Each fermentation unit is fu...
Contract manufacturing of biologics is more than having superior technology — it’s having experienced people who are passionate, responsive, and committed to developing and manufacturing your biotherapeutics to improve patient care. As a fully integrated contract development and manufacturing organization (CDMO), Therapure Biomanufacturing has the scientific and technical expertise to successfully deliver at every stage of product development (preclinical, clinical, and commercial). Our 130,000-ft
2
(12,000-m
2
) CGMP manufacturing facility meets FDA, EMA, and HPFB regulatory standards and includes flexible clinical and commercial production suites.
Development Services
Therapure appreciates the complexity of the development process. Our range of services is supported by a deep scientific understanding of process and analytical development. Our development services include
Cell Line:
generation of well-characterized, stable mammalian cell lines
Upstream:
development of scalable cell culture processes
D...
Vetter, a leading provider of aseptically prefilled drug-delivery systems, operates a state-of-the-art facility at the Illinois Science + Technology Park in suburban Chicago, IL. The site offers a central US location with a domestic and international airline hub. It is uniquely situated in a thriving biopharmaceutical region that offers an established infrastructure and prominent research institutions.
The company’s Chicago site supports preclinical through phase 2 development projects. The 27,000-ft
2
facility’s functional areas include microbiology and chemical analysis laboratories; materials preparation; compounding; aseptic cGMP filling for vials, syringes, and cartridges; quality assurance; and seamless transfer to Vetter Commercial Manufacturing.
DeveIoped at the urging of Vetter’s North American clients, the Chicago site supports small-batch, early stage products. Vetter has extensive experience working with biologics, including monoclonal antibodies, peptides, interferons, and vaccines.
Supporti...
Wacker Biotech is a dedicated contract manufacturer of biopharmaceuticals with over 20 years of experience in microbial systems. Our customers benefit from a comprehensive service for the development of robust and highly efficient production processes and GMP-compliant manufacturing for clinical trials and commercial supply.
Service
Wacker Biotech’s services cover the whole process chain: from construction and optimization of host/vector systems to delivery of the bulk API. A well-equipped quality control department supports characterization of master and working cell banks and development of fermentation and downstream processing as well as GMP-manufacturing. Apart from routine lot-release testing, the quality control department also performs ICH-compliant stability studies. For more flexibility, we can develop the entire production process and analytical methods or transfer projects at each stage.
Projects are managed by dedicated project managers assigned to each project. They coordinate cross-departme...
Analytical techniques that measure protein quantity and quality are used in nearly all stages of research, process development and manufacturing of biotherapeutics. Biopharmaceutical companies have enthusiastically adopted Pall ForteBio’s Octet systems due to their broad utility in protein quantitation and functional characterization combined with no need for labels, real-time monitoring, enhanced throughput, decreased sample preparation requirements, and low cost of operation.
Concentration Measurement
The Octet platform uses ForteBio’s proprietary Biolayer Interferometry (BLI) technology to measure concentration in 96-well and 384-well microplate formats. Biosensors coated with a capture molecule (called the ligand) are dipped into analyte solutions to measure binding interactions. A standard curve is generated using known amounts of the protein analyte, and unknown sample concentrations are interpolated from the standard curve.
Quantitation Applications in Drug Development Using Octet Systems
Research ...
As the pharmaceutical industry continues to accelerate its focus on developing biological drugs derived using cell culture processes, the ability to accurately monitor osmolality throughout each phase of development, production, and finished product quality control (QC) becomes increasingly important. Osmolality is arguably one of the most important physical parameters to monitor in mammalian cell cultures because of its fundamental implications to the growth, viability, yield, and the close relationship between cells and media. Freezing point osmometers are considered the gold-standard method in the pharmaceutical industry because of their accuracy and broad applicability for almost any liquid sample type, including complex media mixtures.
Application of Freezing Point Osmometry
The desirability of osmometer system features often can be remarkably different, depending on the research environment. Cell culture media optimization studies, for example, typically involve multiple experiments using smaller bi...
Switching to single-use systems can have financial and performance benefits. However, one critical challenge for complete acceptance of single-use systems is assurance of bag integrity — and in turn, product sterility and operator safety. The main risk with single-use technology is associated with leaks that can be induced by transport and handling (
1
). The second greatest concern regarding the use of disposables is bag breakage and related loss of production materials (
2
).
Limitations of Pressure-Decay Testing
Pressure decay is the most commonly used integrity test method for flexible containers. A test bag is filled with high-pressure gas. Then the test part is isolated from the gas supply, and after a stabilizing period, its internal pressure is monitored over time. The pressure drop (Δp) is measured in the time (Δt).
Independent third-party laboratories performing bacterial challenge testing on single-use bags have concluded that bacterial ingress can occur through pinholes as small as 15 µm, wher...
Host-cell protein (HCP) analysis is a big issue when it comes to early clinical testing, design of downstream processes, and quality control of biopharmaceuticals. The decision to use an off-the-shelf generic HCP assay or spend a considerable amount of money for development of a specific HCP assay is often not an easy one. In theory, generic HCP assays should be suitable for all HCP determinations of a specific cell line — independent of cell line modifications, fermentation conditions, and the design of the purification process. But in most cases, generic HCP assays do not show the desired specificity and sensitivity.
Enhanced Generic Assay to Detect Host Cell Proteins
BioGenes has developed an enhanced generic CHO 360-HCP assay that is demonstrably superior to current generic HCP assays, allowing sponsors and biotech companies to postpone the development of a cost-intensive specific HCP assay until a more informed decision on the success of a biologic in development can be made.
The CHO 360-HCP assay em...
Flexibility has been the key driving force behind the success and growth of Eurofins Lancaster Laboratories’ viral clearance program.
“When we introduced four levels of service solutions for viral clearance studies, our clients responded well,” says Dr. Kate Bergmann, manager of viral safety and clearance. “They appreciate that we can tailor our program to meet their specific needs. They can use any of our service levels to address all their scientific, safety and scheduling challenges.”
To provide additional capacity, the group is expanding to include four additional viral clearance suites. This growing capacity — along with four flexible service models — enhances the client’s experience and provides significant time and cost savings. Here’s why:
Viral clearance studies are a critical element toward ensuring that an acceptable level of viral safety has been achieved for biological products. The goal of these studies is to demonstrate that the manufacturing purification process has the ability to inactiva...
The ultimate objective in the development of any new therapeutic candidate is the validation of its mechanism of action and therapeutic efficacy in a clinical setting. Three important areas of product development are critical in determining the success of a new drug candidate: manufacturing, safety, and delivery of the product to patients. Early attrition observed during preclinical and initial stages of clinical development fundamentally resides in problems with manufacturing, stability, or safety issues.
A Potential Risk for Everyone: The Cost of Failure
The probability of failure for any new therapeutic candidate during development is extremely high. The Pharmaceutical Research and Manufacturers of America (PhRMA) reports as few as one in 250 candidates in preclinical development will ever be approved for commercial use, and payer constrains on the reimbursement of new therapeutics adds an additional challenge. In this context, the financial impact of preclinical and clinical attrition is often not suf...
