Continuous Process Verification 4.0 application in upstream: adaptiveness implementation managed by AI in the hypoxic bioprocess of the cell factory.

The experimental approach developed in this research demonstrated how the cloud, the Internet of Things (IoT), edge computing, and Artificial Intelligence (AI), considered key technologies in Industry 4.0, provide the expected horizon for adaptive vision in Continued Process Verification (CPV), the final stage of Process Validation (PV). producing lipase 1 under the regulation of the constitutive promoter was selected as an experimental bioprocess.

Synergic kinetic and physiological control to improve the efficiency of Komagataella phaffii recombinant protein production bioprocesses.

The yeast Komagataella phaffii (Pichia pastoris) is currently considered a versatile and highly efficient host for recombinant protein production (RPP). Interestingly, the regulated application of specific stress factors as part of bioprocess engineering strategies has proven potential for increasing the production of recombinant products. This study aims to evaluate the impact of controlled oxygen-limiting conditions on the performance of K.

CPV of the Future: AI-Powered Continued Process Verification for Bioreactor Processes.

According to the standard guidelines by the FDA, process validation in biopharma manufacturing encompasses a life cycle consisting of three stages: process design (PD), process qualification (PQ), and continued process verification (CPV). The validity and efficiency of the analytics methods employed during the CPV require extensive knowledge of the process. However, for new processes and new drugs, such knowledge is often not available from Process performance qualification and Validation (PPQV).

Innovative Bioprocess Strategies Combining Physiological Control and Strain Engineering of to Improve Recombinant Protein Production.

The combination of strain and bioprocess engineering strategies should be considered to obtain the highest levels of recombinant protein production (RPP) while assuring product quality and process reproducibility of heterologous products. In this work, two complementary approaches were investigated to improve bioprocess efficiency based on the yeast . Firstly, the performance of two lipase 1 producer clones with different gene dosage under the regulation of the constitutive were compared in chemostat cultures with different oxygen-limiting conditions.

Source of fungus contamination of hydrophilic soft contact lenses.

Fungus infiltration within hydrophilic lenses has been a rare finding. This case report confirms previous findings that fungal contamination of hydrophilic contact lens is possible. The present report, to our knowledge, is the first demonstration of the association of fungus from contaminated cosmetics with hydrophilic contact lenses.

Lamellar keratoplasty in the treatment of keratoconus: conectomy.

The first 52 eyes of 48 keratoconus patients treated with conectomy and followed for a period of time ranging from 6 to 48 months are included in this study. An average change in the refractive power of the cornea of 10.3 diopters was found after conectomy.

A comparison of penetrating keratoplasty and lamellar keratoplasty in the surgical management of keratoconus.

A retrospective study of patients who underwent keratoplasty for keratoconus was done in 100 consecutive cases, of which 50 were penetrating keratoplasty procedures, and 50 were lamellar keratoplasty procedures. Each case was done by the same surgeon in both series. Criteria for patient selection were essentially the same.

Aphakic soft contact lens update.

Problems with the N series were mainly due to poor or viable visual acuity that could not be rectified by correcting the residual refractive error in spectacle overrefraction. The error lay mainly in the design of the lens and the fitting rationale. The introduction of lenses (B3 and F3) with base curve and power that adequately covered a wider range of aphakic eyes has solved the fitting problems in most cases.

Keratoconus and atopic diseases.

In a survey of 162 keratoconus patients, we set out to investigate individual conditions, such as asthma, hay fever, connective tissue syndromes, and eye rubbing, and to determine their relationship of keratoconus. It was found that the prevalence of asthma rises from 0.4% to 1% in the control group to 17.

Genetics in keratoconus: A, B, O blood groups.

A, B, O blood group frequencies and Rh factors were studied in 69 white keratoconus patients and compared with 1,465 healthy white individuals. We did not detect a significant excess of any particular blood group among keratoconus patients. It was concluded that blood groups were not associated with keratoconus.

Hard contact lens wear as an environmental risk in keratoconus.

We studied 162 keratoconus patients in an attempt to clarify the role of hard contact lens wear in the development of keratoconus. Forty-three (26.5%) of these 162 patients developed keratoconus while wearing hard contact lenses.

Benzalkonium chloride toxicity to the human cornea.

A 36-year-old woman fitted with a soft contact lens after an uneventful extracapsular cataract extraction was wearing her aphakic lens successfully until she switched her lens-soaking solution to an isotonic solution of boric acid, potassium chloride, and sodium carbonate preserved with benzalkonium chloride and edetic acid. After three days her eye became inflamed and vision decreased. No endothelial damage was apparent and the anterior chamber showed 2+ cell and flare reaction.

Simplified soft contact lens treatment in corneal diseases.

The advantages and disadvantages of the newly introduced Plano-T soft contact lens for the treatment of corneal diseases were evaluated. The physical characteristics, base curve, diameter, and thickness account for the fitting advantages which make it a versatile lens. The assumption that one lens fits almost any eye and that it may be used in most instances where a bandage lens is indicated proved correct, except for corneas of extreme measurements as in keratoconus.

Embryopathic effect of ophthalmic EDTA.

Studies on the potential teratogenic effect of topically applied EDTA (0.1% and 3%) were undertaken because of its proven teratogenic effects when administered systemically and because of its wide use as an ophthalmic drug. Although no teratogenic effect was found for either 0.

HLA antigens and keratoconus.

Significant associations have been found between the HLA antigens or haplotypes and certain diseases and deficiencies. These associations have opened up new areas of clinical investigation. In man, associations have been shown between the presence of Hodgkin's Disease and a number of cross-reacting HLA types (BW5, BW15, BW18), between systemic Lupus erythematosus and HLA type BW15 in Caucasians and BW35 in blacks, between HLA B37 and ankylosing spondylitis in Caucasians, between HLA B8 and gluten-sensitive enteropathy and between HLA B13 and psoriasis, a disease having a strong hereditary element.

Pharmacogenetics in keratoconus.

Genetic markers such as phenylthiourea (PTC) taste has been used as a simple test in genetically determined diseases. A solution of 8.1 mg PTC in 100 ml of water was used as the antimode.

Permanent wear of soft contact lenses in aphakic eyes.

In a five-year study, permanent wear of soft contact lenses was achieved by selecting patients and lenses properly, and offered a viable and probably safer alternative to intraocular lenses. Twenty-five of these 49 patients wore their initial lens or a similar lens continuously for over three years. A visual acuity of 6/12 (20/40) or better was obtained in 45 (91.

Teratogenicity of adenine arabinoside (Ara-A).

The potentially teratogenic effect of antiviral drugs, particularly when given systemically, prompted the evaluation of the teratogenic effect of Ara-A when given systemically in doses significantly higher than those used clinically. Under the conditions of this study, neither teratogenic nor embryocidal effects of Ara-A were observed.

The effect of 10-0 running nylon versus 8-0 silk on the healing of corneal gragts.

A previously reported well standardized tensile strength model in rabbits was sued in order to answer whether or not monofilament nylon does in fact delay corneal wound healing in general, and in particular, in corneal grafts. The tensile strength of penetrating keratoplasty wounds closed with either 10-0 running monofilament nylon or 8-0 interrupted black silk was measured in rabbits. The tensile strength of wounds closed with either suture was comparable in all groups.

[The effect of Actihaemyl on epithelial regeneration (author's transl)].

After well-defined chemical and mechanical removal of the corneal epithelium of 40 rabbit eyes 20 eyes were treated with Actihaemyl-Augengel 4 times daily. The epithelial regeneration was compared with the untreated contralateral eye. Under Actihaemyl treatment the healing rate was not accelerated.

Antiviral drugs and corneal wound healing.

Using a previously described well standardized wound strength model, the fate of different antiviral drugs from corneal wound healing was evaluated. While 1.0 per cent trifluorothymidine and 0.

Hydrogen peroxide sterilization of hydrophilic contact lenses.

A new, simple, and effective procedure for the sterilization of soft contact lenses utilizes hydrogen peroxide, an inexpensive and readily availiable solution.

Thermokeratoplasty in the treatment of keratoconus.

Of 59 keratoconus eyes treated with the thermokeratoplasty procedure and followed for as long as two years visual acuity improved to better than 20/30 in most. Despite the varied procedures, temperatures, sites and duration of application, sizes and shapes of the probe, as well as follow-up periods, the results were satisfactory and compared favorably with the results of penetrating keratoplasty. Thermokeratoplasty did not preclude later penetrating keratoplasty.